Scheduled In-house

Pharmaceutical Training Courses

Discovery, development and manufacture of drugs are central to the pharmaceutical industry. Keeping up to date with the latest regulations and new discoveries in this fast-paced environment is essential for all professionals working within this industry. Our pharmaceutical industry training courses have been designed to focus on latest developments and best practice, presented by industry experts on key topics across the pharmaceutical lifecycle, including clinical, regulatory, pharmacovigilance, medical writing and biopharma.

By attending our pharmaceutical industry training courses online or in person, you will also gain the opportunity to network and discuss topics with other like-minded pharmaceutical professionals.

  • Next: 5-6 Oct 2022 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours
  • Presented by Dr John Price
  • Next: 6-7 Oct 2022 Live online

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 10-11 Oct 2022 Live online

The FDA Drug Approval Process

Live online
Focused

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 10 Oct 2022 Live online

Data Integrity and Document Management

Live online
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 11-12 Oct 2022 Live online

Biosimilars

Live online
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 11-12 Oct 2022 Live online

Effective Technology Transfer

Live online
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 13-14 Oct 2022 Live online

Variations to Marketing Authorisations

Live online
Focused

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • + 2 more
  • Next: 14 Oct 2022 Live online

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 17-18 Oct 2022 Live online

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 18-19 Oct 2022 Live online

EU Pharmaceutical Regulations & Strategy

Live online
Focused

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 2-4 Nov 2022 Live online

European Post Marketing Pharmacovigilance

New for 2022

Live online
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Presented by Dr Graeme Ladds
  • Next: 4 Nov 2022 Live online

Drafting and Negotiating Clinical Trial Agreements

Live online
Focused

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

  • 6 CPD hours
  • Presented by Alex Denoon
  • Next: 7-8 Nov 2022 Live online

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 8-10 Nov 2022 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 9-11 Nov 2022 Live online

The Pharma Mini MBA

Live online
Focused

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

  • 18 CPD hours
  • Presented by Dr Laura Brown
  • and Oguz Ozden
  • Next: 14-15 Nov 2022 Live online

Positive Persuading and Influencing Skills for Pharma Professionals

Live online
Focused

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

  • 12 CPD hours
  • Presented by Mr Robert Hersowitz
  • Next: 14-15 Nov 2022 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 16-17 Nov 2022 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 16-17 Nov 2022 Live online

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 17-18 Nov 2022 Live online

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 17-18 Nov 2022 Live online

Understanding Active Pharmaceutical Ingredients (APIs) - A Comprehensive and Practical Introduction

New for 2022

Live online
Focused

This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 21 Nov 2022 Live online

Root Cause Analysis (RCA) and Critical Thinking

New for 2022

Live online
Focused

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 21-23 Nov 2022 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

New for 2022

Live online
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 22-23 Nov 2022 Live online

Pharmaceutical Regulatory Affairs in China

Live online
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 23-25 Nov 2022 Live online

Drafting Commercial Contracts for the Pharmaceutical Industry

Live online
Focused

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

  • 18 CPD hours
  • Presented by Graham Roberts-Phelps
  • + 13 more
  • Next: 23-24 Nov 2022 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • Next: 28-29 Nov 2022 Live online

The Common Technical Document

Live online
Focused

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 28-29 Nov 2022 Live online

Understanding Computer System Validation (CSV) - A Comprehensive and Practical Introduction

New for 2022

Live online
Focused

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 29-30 Nov 2022 Live online

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 29 Nov 2022 Live online

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2022

Live online
High impact

‘Better regulation…for better trials…for better health’ The Medicines and Healthcare products Regulatory Agency (MHRA) have set far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. This webinar will bring you up-to-date with the current position regarding the proposals and the potential implications and opportunities for the industry.

  • 1.5 CPD hours
  • Presented by Dr David Jefferys
  • Next: 1 Dec 2022 Live online

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by Mr Brian Kelly
  • and Ms Penny Viner
  • Next: 1 Dec 2022 Live online

An Essential Overview of Medical Information

Live online
Focused

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 2 Dec 2022 Live online

An Essential Overview of the Medical Device Industry

Live online
Focused

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • Next: 5-9 Dec 2022 Live online

Biotechnology for the Non-Biotechnologist

Live online
Focused

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

  • 18 CPD hours
  • Presented by Dr Adekunle Onadipe
  • + 6 more
  • Next: 7-9 Dec 2022 Classroom

Advanced Pharmacovigilance

Classroom
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 8-9 Dec 2022 Live online

Project Management for Pharma Professionals

Live online
Focused

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health Includes: Interactive workshop sessions

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 12 Dec 2022 Live online

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 12-13 Dec 2022 Live online

Pharmaceutical Packaging, Labelling and Artwork Origination

Live online
Focused

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

  • 12 CPD hours
  • Presented by Mr Christopher Waterhouse
  • + 6 more
  • Next: 13 Dec 2022 Live online

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 13 Dec 2022 Classroom

An Introduction to Quality Management for Managers

New for 2022

Classroom
Focused

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 14 Dec 2022 Classroom

Effective Technical Writing & Editing

Classroom
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • Next: 14-16 Dec 2022 Live online

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 4 more
  • Next: 14-15 Dec 2022 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 14-16 Dec 2022 Live online

The Pharma Mini MBA

Live online
Focused

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

  • 18 CPD hours
  • Presented by Dr Laura Brown
  • and Oguz Ozden
  • Next: 16-17 Jan 2023 Live online

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 17-18 Jan 2023 Live online

Process Validation with Qualification

Live online
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 18-19 Jan 2023 Live online

GMP Fundamentals

New for 2023

Live online
Focused

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

  • Presented by Rob Hughes
  • Next: 19 Jan 2023 Live online

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 20 Jan 2023 Live online

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 20 Jan 2023 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 23-24 Jan 2023 Live online

Clinical Trial Regulatory Requirements

Live online
Focused

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and key difference it compares with the Clinical Directive requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 23-26 Jan 2023 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 24-25 Jan 2023 Live online

Effective Technology Transfer

Live online
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 26 Jan 2023 Live online

Quality Management Refresher

New for 2023

Live online
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 30-31 Jan 2023 Live online

MBA Strategic Thinking for Pharma and Biopharma Professionals

Live online
Focused

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 30-31 Jan 2023 Live online

Regulatory Affairs for Support Staff

Live online
Focused

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 31 Jan 2023 Live online

An Essential Overview of Pharmacovigilance

Live online
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 31 Jan-3 Feb 2023 Live online

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • Next: 1-3 Feb 2023 Live online

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 4 more
  • Next: 1-2 Feb 2023 Live online

Effective Technical Writing & Editing

Live online
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • Next: 2-3 Feb 2023 Live online

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 3 Feb 2023 Live online

Drafting and Negotiating Clinical Trial Agreements

Live online
Focused

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

  • 6 CPD hours
  • Presented by Alex Denoon
  • Next: 6-9 Feb 2023 Live online

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 7-9 Feb 2023 Live online

Drafting Commercial Contracts for the Pharmaceutical Industry

Live online
Focused

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

  • 18 CPD hours
  • Presented by Graham Roberts-Phelps
  • + 13 more
  • Next: 8-10 Feb 2023 Live online

The Pharma Mini MBA

Live online
Focused

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

  • 18 CPD hours
  • Presented by Dr Laura Brown
  • + 2 more
  • Next: 8-9 Feb 2023 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours
  • Presented by Dr John Price
  • Next: 9-10 Feb 2023 Live online

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 20-23 Feb 2023 Live online

EU Pharmaceutical Regulations & Strategy

Live online
Focused

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 20-21 Feb 2023 Live online

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 20-21 Feb 2023 Live online

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 22-24 Feb 2023 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 27 Feb 2023 Live online

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 2-3 Mar 2023 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • Next: 2-3 Mar 2023 Live online

Agile Leadership for Pharma and Biopharma Professionals in a virtual world

Live online
Focused

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 2-3 Mar 2023 Live online

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

Live online
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 6-9 Mar 2023 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 6-10 Mar 2023 Live online

European Post Marketing Pharmacovigilance

Live online
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Presented by Dr Graeme Ladds
  • Next: 10 Mar 2023 Live online

GCP and Clinical Research Update - Hot Inspection Topics

Live online
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 16-17 Mar 2023 Live online

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 16 Mar 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 17 Mar 2023 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 22-23 Mar 2023 Live online

Positive Persuading and Influencing Skills for Pharma Professionals

Live online
Focused

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

  • 12 CPD hours
  • Presented by Mr Robert Hersowitz
  • Next: 22-24 Mar 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

Live online
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 23 Mar 2023 Live online

Root Cause Analysis (RCA) and Critical Thinking

Live online
Focused

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 27 Mar 2023 Live online

An Introduction to Quality Management for Managers

Live online
Focused

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 29 Mar 2023 Live online

An Essential Overview of the Medical Device Industry

Live online
Focused

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • Next: 29-31 Mar 2023 Live online

Advanced Pharmacovigilance

Live online
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 30-31 Mar 2023 Live online

Project Management for Pharma Professionals

Live online
Focused

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health Includes: Interactive workshop sessions

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 17-18 Apr 2023 Live online

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 17-18 Apr 2023 Live online

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 17-18 Apr 2023 Live online

Pharmaceutical Regulatory Affairs in China

Live online
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 19-20 Apr 2023 Live online

GMP Fundamentals

New for 2023

Live online
Focused

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

  • Presented by Rob Hughes
  • Next: 19-21 Apr 2023 Classroom

Successful Medical Writing

Classroom
Focused

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours
  • Presented by Ms Barbara Grossman
  • + 2 more
  • Next: 19-20 Apr 2023 Live online

Effective Technology Transfer

Live online
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 20-21 Apr 2023 Live online

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 21 Apr 2023 Live online

Data Integrity and Document Management

Live online
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 24-25 Apr 2023 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 26-27 Apr 2023 Live online

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by Mr Brian Kelly
  • and Ms Penny Viner
  • Next: 26-27 Apr 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Live online
Focused

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 27 Apr 2023 Live online

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 27-28 Apr 2023 Live online

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 28 Apr 2023 Live online

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 3-5 May 2023 Live online

The Pharma Mini MBA

Live online
Focused

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

  • 18 CPD hours
  • Presented by Dr Laura Brown
  • + 2 more
  • Next: 3-5 May 2023 Classroom

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

Classroom
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 8-9 May 2023 Live online

Quality Management Refresher

New for 2023

Live online
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 9-10 May 2023 Classroom

Regulatory Affairs for Support Staff

Classroom
Focused

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 11 May 2023 Live online

Drafting and Negotiating Clinical Trial Agreements

Live online
Focused

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

  • 6 CPD hours
  • Presented by Alex Denoon
  • Next: 12 May 2023 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 15-16 May 2023 Live online

MBA Strategic Thinking for Pharma and Biopharma Professionals

Live online
Focused

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 17-18 May 2023 Classroom

Process Validation with Qualification

Classroom
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 18 May 2023 Classroom

An Essential Overview of Pharmacovigilance

Classroom
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 22-23 May 2023 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 22-23 May 2023 Live online

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 23-24 May 2023 Live online

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • Next: 25-26 May 2023 Classroom

Clinical Trial Regulatory Requirements

Classroom
Focused

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and key difference it compares with the Clinical Directive requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 1 Jun 2023 Classroom

An Essential Overview of Medical Information

Classroom
Focused

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 5-6 Jun 2023 Live online

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 7-9 Jun 2023 Classroom

Advanced Pharmacovigilance

Classroom
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 9 Jun 2023 Live online

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 13-14 Jun 2023 Classroom

EU Pharmaceutical Regulations & Strategy

Classroom
Focused

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 14 Jun 2023 Classroom

An Introduction to Quality Management for Managers

Classroom
Focused

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 14 Jun 2023 Classroom

Effective Technical Writing & Editing

Classroom
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • Next: 14-16 Jun 2023 Classroom

Pharmacovigilance

Classroom
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 4 more
  • Next: 14-16 Jun 2023 Classroom

Pharmaceutical Regulatory Affairs in Asia

Classroom
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 19-20 Jun 2023 Classroom

Project Management for Pharma Professionals

Classroom
Focused

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health Includes: Interactive workshop sessions

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 20-21 Jun 2023 Classroom

Pharmaceutical Development of ATMPs

Classroom
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 21-22 Jun 2023 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours
  • Presented by Dr John Price
  • Next: 26-29 Jun 2023 Live online

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online
Focused

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 27-28 Jun 2023 Classroom

Development of Combination Products: Critical Interactions

Classroom
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 27-29 Jun 2023 Classroom

European Post Marketing Pharmacovigilance

Classroom
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Presented by Dr Graeme Ladds
  • Next: 29-30 Jun 2023 Classroom

GMP Fundamentals

New for 2023

Classroom
Focused

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

  • Presented by Rob Hughes
  • Next: 3-4 Jul 2023 Classroom

Signal Detection and Regulatory Expectations

Classroom
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 3-4 Jul 2023 Classroom

Agile Leadership for Pharma and Biopharma Professionals in a virtual world

Classroom
Focused

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 5-6 Jul 2023 Live online

Positive Persuading and Influencing Skills for Pharma Professionals

Live online
Focused

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

  • 12 CPD hours
  • Presented by Mr Robert Hersowitz
  • Next: 6-7 Jul 2023 Classroom

Clinical Quality Management Systems

Classroom
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 6-7 Jul 2023 Classroom

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

Classroom
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 10-12 Jul 2023 Classroom

Drafting Commercial Contracts for the Pharmaceutical Industry

Classroom
Focused

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

  • 18 CPD hours
  • Presented by Claire Smith
  • + 13 more
  • Next: 10-11 Jul 2023 Classroom

Managing Vendor/CRO/CMO Oversight

Classroom
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 10-11 Jul 2023 Live online

An Essential Overview of the Medical Device Industry

Live online
Focused

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • Next: 12 Jul 2023 Classroom

Smart Packaging and Electronic Patient Information

New for 2023

Classroom
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 12 Jul 2023 Classroom

Pharmacovigilance Aspects of Licensing Agreements

Classroom
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 13-14 Jul 2023 Classroom

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Classroom
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 13-14 Jul 2023 Classroom

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Classroom
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 13-14 Jul 2023 Classroom

Pharmaceutical Regulatory Affairs in China

Classroom
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 14 Jul 2023 Live online

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by Mr Brian Kelly
  • and Ms Penny Viner
  • Next: 17 Jul 2023 Live online

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 18-19 Jul 2023 Classroom

Effective Technology Transfer

Classroom
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 18 Jul 2023 Live online

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 19-20 Jul 2023 Classroom

Pharmaceutical Regulatory Affairs in the Middle East

Classroom
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 20 Jul 2023 Classroom

GCP and Clinical Research Update - Hot Inspection Topics

Classroom
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 21 Jul 2023 Classroom

Drafting and Negotiating Clinical Trial Agreements

Classroom
Focused

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

  • 6 CPD hours
  • Presented by Alex Denoon
  • Next: 24 Jul 2023 Classroom

Data Integrity and Document Management

Classroom
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 24 Jul 2023 Live online

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 25 Jul 2023 Live online

A Practical Guide to Producing and Maintaining the PSMF

Live online
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 25 Jul 2023 Classroom

Root Cause Analysis (RCA) and Critical Thinking

Classroom
Focused

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 25-26 Jul 2023 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • Next: 2-4 Aug 2023 Classroom

The Pharma Mini MBA

Classroom
Focused

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

  • 18 CPD hours
  • Presented by Dr Laura Brown
  • + 2 more
  • Next: 2-4 Aug 2023 Classroom

Successful Medical Writing

Classroom
Focused

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours
  • Presented by Ms Barbara Grossman
  • + 2 more
  • Next: 11-12 Sep 2023 Live online

An Essential Overview of Pharmacovigilance

Live online
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 14-15 Sep 2023 Live online

An Introduction to Quality Management for Managers

Live online
Focused

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 15 Sep 2023 Live online

An Essential Overview of the Pharmaceutical and Biotech Industries

Live online
Focused

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 20-22 Sep 2023 Live online

Advanced Pharmacovigilance

Live online
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 21-22 Sep 2023 Live online

Clinical Trial Regulatory Requirements

Live online
Focused

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and key difference it compares with the Clinical Directive requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 25-26 Sep 2023 Classroom

MBA Strategic Thinking for Pharma and Biopharma Professionals

Classroom
Focused

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 26-29 Sep 2023 Live online

Regulatory Affairs for Support Staff

Live online
Focused

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 27-28 Sep 2023 Classroom

Process Validation with Qualification

Classroom
Focused

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 27-28 Sep 2023 Live online

An Introduction to Pharmaceutical Packaging

Live online
Focused

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours
  • Presented by Mr Chris Penfold
  • Next: 28-29 Sep 2023 Live online

Project Management for Pharma Professionals

Live online
Focused

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health Includes: Interactive workshop sessions

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 28 Sep 2023 Classroom

Quality Management Refresher

New for 2023

Classroom
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 28-29 Sep 2023 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 2 Oct 2023 Classroom

A Practical Guide to Writing Risk Management Plans (RMPs)

Classroom
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 2-4 Oct 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

Live online
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 3 Oct 2023 Classroom

A Practical Guide to Producing and Maintaining the PSMF

Classroom
Focused

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 4-5 Oct 2023 Live online

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Live online
Focused

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

  • 6 CPD hours
  • Presented by Dr John Price
  • Next: 5-6 Oct 2023 Classroom

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Classroom
Focused

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 9-12 Oct 2023 Live online

Development of Combination Products: Critical Interactions

Live online
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 9-10 Oct 2023 Live online

Clinical Trial Monitoring

New for 2023

Live online

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 11-13 Oct 2023 Live online

Pharmaceutical Regulatory Affairs in Asia

Live online
Focused

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

  • 18 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 11-13 Oct 2023 Live online

Pharmacovigilance

Live online
Focused

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 4 more
  • Next: 12-13 Oct 2023 Classroom

Effective Technology Transfer

Classroom
Focused

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 13 Oct 2023 Live online

Risk Management for Pharma and Biopharma Professionals

Live online
Focused

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 16-17 Oct 2023 Live online

Pharmaceutical Development of ATMPs

Live online
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 16-17 Oct 2023 Live online

EU Pharmaceutical Regulations & Strategy

Live online
Focused

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

  • 12 CPD hours
  • Presented by Mrs Norah Lightowler
  • Next: 17-20 Oct 2023 Live online

GMP Fundamentals

New for 2023

Live online
Focused

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

  • Presented by Rob Hughes
  • Next: 19-20 Oct 2023 Live online

Managing Vendor/CRO/CMO Oversight

Live online
Focused

Optimising oversight for inspection compliance

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 19-20 Oct 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Live online
Focused

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 20 Oct 2023 Live online

Effective Technical Writing & Editing

Live online
Focused

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

  • 6 CPD hours
  • Presented by Ms Barbara Grossman
  • Next: 26-27 Oct 2023 Live online

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

Live online
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 6 Nov 2023 Live online

Root Cause Analysis (RCA) and Critical Thinking

Live online
Focused

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 6-7 Nov 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 6-10 Nov 2023 Live online

European Post Marketing Pharmacovigilance

Live online
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Presented by Dr Graeme Ladds
  • Next: 7 Nov 2023 Live online

Drafting and Negotiating Clinical Trial Agreements

Live online
Focused

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

  • 6 CPD hours
  • Presented by Alex Denoon
  • Next: 8-10 Nov 2023 Live online

The Pharma Mini MBA

Live online
Focused

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

  • 18 CPD hours
  • Presented by Dr Laura Brown
  • + 2 more
  • Next: 10 Nov 2023 Live online

An Essential Overview of the Medical Device Industry

Live online
Focused

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours
  • Presented by Dr David Jefferys
  • and Ms Theresa Jeary
  • Next: 13-14 Nov 2023 Live online

EU Clinical Trial Regulation 536/2014: Overview and Implementation

Live online
Focused

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 13-14 Nov 2023 Live online

Positive Persuading and Influencing Skills for Pharma Professionals

Live online
Focused

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

  • 12 CPD hours
  • Presented by Mr Robert Hersowitz
  • Next: 13-14 Nov 2023 Live online

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online
Focused

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours
  • Presented by Mr Paul Palmer
  • Next: 14-17 Nov 2023 Live online

Signal Detection and Regulatory Expectations

Live online
Focused

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 16-17 Nov 2023 Live online

Clinical Quality Management Systems

Live online
Focused

A two-day course that will ensure you comply with new regulatory requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 20-21 Nov 2023 Live online

Agile Leadership for Pharma and Biopharma Professionals in a virtual world

Live online
Focused

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 21-24 Nov 2023 Live online

Pharmaceutical Regulatory Affairs in Africa

Live online
Focused

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

  • 12 CPD hours
  • Presented by Mr Makram Nehme
  • and Salma Ismail
  • Next: 22-24 Nov 2023 Live online

Drafting Commercial Contracts for the Pharmaceutical Industry

Live online
Focused

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

  • 18 CPD hours
  • Presented by Graham Roberts-Phelps
  • + 13 more
  • Next: 24 Nov 2023 Live online

GCP and Clinical Research Update - Hot Inspection Topics

Live online
Focused

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 29-30 Nov 2023 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 1 Dec 2023 Live online

Data Integrity and Document Management

Live online
Focused

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 1 Dec 2023 Live online

Borderlines between Medicines and Food

Live online
Focused

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

  • 6 CPD hours
  • Presented by Mr Brian Kelly
  • and Ms Penny Viner
  • Next: 1 Dec 2023 Live online

An Introduction to Quality Management for Managers

Live online
Focused

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Live online
Focused

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 4-5 Dec 2023 Live online

Project Management for Pharma Professionals

Live online
Focused

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health Includes: Interactive workshop sessions

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 6-8 Dec 2023 Live online

Successful Medical Writing

Live online
Focused

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

  • 18 CPD hours
  • Presented by Ms Barbara Grossman
  • + 2 more
  • Next: 11-14 Dec 2023 Live online

Pharmaceutical Regulatory Affairs in the Middle East

Live online
Focused

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 11-15 Dec 2023 Live online

Advanced Pharmacovigilance

Live online
Focused

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 12-13 Dec 2023 Live online

Pharmaceutical Regulatory Affairs in China

Live online
Focused

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

  • 12 CPD hours
  • Presented by Dr Alan Chalmers
  • and Ms Monica Dressler-Meyer
  • Next: 14 Dec 2023 Live online

Best Practice for Writing Effective SOPs

Live online
Focused

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Next: 15 Dec 2023 Live online

CAPA (Corrective and Preventative Action)

Live online
Focused

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

  • 6 CPD hours
  • Presented by Dr Laura Brown