Scheduled In-house

Pharmaceutical Training Courses

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

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.

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  • Next: on request

Borderlines between Medicines and Food

Bespoke
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
  • Next: on request

Pharmaceutical Packaging, Labelling and Artwork Origination

Bespoke
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
  • Next: 17 May 2023 Live online
  • Also: 25 Jul 2023 Live online
  • Also: 6 Oct 2023 Classroom

A Practical Guide to Producing and Maintaining the PSMF

Live online, 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: 20-21 Apr 2023 Live online
  • Also: 24 Jul 2023 Live online
  • Also: 5 Oct 2023 Classroom

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online, 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: 22-24 Mar 2023 Live online
  • Also: 7-9 Jun 2023 Classroom
  • Also: 20-22 Sep 2023 Live online
  • Also: 11-15 Dec 2023 Live online

Advanced Pharmacovigilance

Live online, 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: 2-3 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Live online
  • Also: 20-21 Nov 2023 Live online

Agile Leadership for Pharma and Biopharma Professionals in a hybrid 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 Jun 2023 Live online
  • Also: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Updated for 2023

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: 31 Jan 2023 Live online
  • Also: 18 May 2023 Live online
  • Also: 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: 29 Mar 2023 Live online
  • Also: 10-11 Jul 2023 Live online
  • Also: 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: 12 May 2023 Live online
  • Also: 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: 31 Jan-3 Feb 2023 Live online
  • Also: 23-25 May 2023 Live online
  • Also: 27-29 Sep 2023 Classroom

An Introduction to Pharmaceutical Packaging

Live online, Classroom
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: 27 Mar 2023 Live online
  • Also: 14 Jun 2023 Live online
  • Also: 14-15 Sep 2023 Live online
  • Also: 1 Dec 2023 Live online

An Introduction to Quality Management for Managers

New for 2023

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: 28 Apr 2023 Live online
  • Also: 17 Jul 2023 Live online
  • Also: 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: 12-13 Jul 2023 Live online
  • Also: 30-31 Oct 2023 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: 26-28 Apr 2023 Classroom
  • Also: 26-30 Jun 2023 Live online
  • Also: 27-29 Sep 2023 Classroom
  • Also: 4-8 Dec 2023 Live online

Biotechnology for the Non-Biotechnologist

Live online, Classroom
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: 27 Apr 2023 Live online
  • Also: 18 Jul 2023 Live online
  • Also: 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
  • Next: 2-3 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Live online
  • Also: 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: 8-9 Feb 2023 Live online
  • Also: 21-22 Jun 2023 Live online
  • Also: 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: 16-17 Mar 2023 Live online
  • Also: 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: 24 Feb 2023 Live online
  • Also: 2 Jun 2023 Live online
  • Also: 6 Oct 2023 Live online

Clinical Research - A Different Approach to Successful Project Delivery

New for 2023

Live online

Project management is not standing still, new ideas and ways of looking at project delivery are constantly changing. This workshop is designed to help you think differently about clinical research projects. Some of the concepts like System Thinking, the Theory of Constraints and Agile Project Management are not new but are often untried in our heavily regulated environment. Other techniques like Relational Risk and Complexity are very much at the forefront of current research. This course will provide you with key techniques to apply during your clinical research project to aid successful delivery.

  • 6 CPD hours
  • Presented by Mr Roger Joby
  • Next: 5-6 Jun 2023 Live online
  • Also: 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: 25-26 May 2023 Classroom
  • Also: 18-19 Sep 2023 Live online

Clinical Trial Regulatory Requirements

Live online, 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 one year on and a brief review of key FDA requirements.

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 15-16 May 2023 Live online
  • Also: 19-20 Sep 2023 Live online

Consultative Selling for Pharma Professionals

New for 2023

Live online

In this two-day workshop, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.

  • 12 CPD hours
  • Presented by Mr Robert Hersowitz
  • Next: 22-23 Jun 2023 Live online

Cosmetovigilance

Updated for 2023

Live online
Focused

This course will provide a comprehensive overview to Cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will cover the applicable legislation, the regulatory requirements, what needs to be reported, the role of the Responsible Person, borderline products and promotional claims. Essentially it will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 21 Apr 2023 Live online
  • Also: 24 Jul 2023 Live online
  • Also: 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: 27-28 Jun 2023 Live online
  • Also: 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: 11 May 2023 Live online
  • Also: 21 Jul 2023 Live online
  • Also: 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: 8-9 Mar 2023 Live online
  • Also: 26-27 Jul 2023 Classroom
  • Also: 2-3 Nov 2023 Live online

Drafting and Reviewing Supply, Distribution and Master Service Contracts for the Pharma Industry

New for 2023

Live online, Classroom
Focused

This intensive two-day programme will equip you to be able to successfully draft and review these contracts for the pharma and healthcare industry.

  • 12 CPD hours
  • Presented by Mrs Rachel Corder
  • Next: 9 Feb 2023 Live online
  • Also: 10-12 Jul 2023 Classroom
  • Also: 22-24 Nov 2023 Live online

Drafting Commercial Contracts for the Pharmaceutical Industry

Live online, 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 Dr Ben Thomas
  • + 14 more
  • Next: 11-12 May 2023 Live online
  • Also: 21-22 Sep 2023 Live online

Drug Discovery: A Step-by-Step Introduction

New for 2023

Live online
Focused

The course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful discovery project.

  • 12 CPD hours
  • Presented by Dr Peter A. Lowe
  • Next: 23 Jun 2023 Live online
  • Also: 3 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: 19-20 Apr 2023 Live online
  • Also: 18-19 Jul 2023 Classroom
  • Also: 12-13 Oct 2023 Classroom

Effective Technology Transfer

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Mr Bruce Davis
  • Next: 20-21 Mar 2023 Live online
  • Also: 20-21 Jul 2023 Live online
  • Also: 16-17 Nov 2023 Live online

Effective Training Skills and Processes in the Pharma Industry

Updated for 2023

Live online

Interactive course ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).

  • 12 CPD hours
  • Presented by Dr Laura Brown
  • Next: 23-24 Feb 2023 Live online
  • Also: 22-23 May 2023 Live online
  • Also: 13-14 Jul 2023 Live online
  • Also: 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 and update from Go Live from 2022 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: 20-23 Feb 2023 Live online
  • Also: 13-14 Jun 2023 Classroom
  • Also: 16-17 Oct 2023 Live online

EU Pharmaceutical Regulations & Strategy

Live online, 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: 6-10 Mar 2023 Live online
  • Also: 27-29 Jun 2023 Live online
  • Also: 6-10 Nov 2023 Live online

European Post Marketing Pharmacovigilance - Including the EMA/PRAC deliberations and Brexit implications

New for 2023

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: 24 Apr 2023 Live online
  • Also: 21 Jul 2023 Live online
  • Also: 17 Oct 2023 Live online

Filing eCTD Submissions

Live online
Focused

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

  • 6 CPD hours
  • Presented by Hans van Bruggen
  • + 3 more
  • Next: 10 Mar 2023 Live online
  • Also: 3 Jul 2023 Live online
  • Also: 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: 19-20 Apr 2023 Live online
  • Also: 29-30 Jun 2023 Live online
  • Also: 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: 7 Mar 2023 Live online
  • Also: 9 Jun 2023 Live online
  • Also: 6 Oct 2023 Live online

Licensing & Acquisitions in the Pharmaceutical & Healthcare Industry

New for 2023

Live online
Focused

An insider's view of the business development process of licensing and acquisitions in the pharmaceutical & healthcare industry.

  • 6 CPD hours
  • Presented by Mrs Rachel Corder
  • Next: 19-20 Apr 2023 Live online
  • Also: 10-11 Jul 2023 Live online
  • Also: 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: 30-31 Jan 2023 Live online
  • Also: 15-16 May 2023 Live online
  • Also: 25-26 Sep 2023 Classroom

MBA Strategic Thinking for Pharma and Biopharma Professionals

Live online, 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: 8 Mar 2023 Live online
  • Also: 27 Sep 2023 Live online

Metrics and Earned Value in Clinical Research Projects

New for 2023

Live online
Masterclass

The above quotation from Michael Hammer is as valid today as it was when he first said it. This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. The session will look at deliverables and the important part that they play in the calculation of the Earned Value (EV), which is the ultimate leading metric and key performance indicator (KPI) for project progress. A valuable master class for anyone involved in clinical research.

  • 3 CPD hours
  • Presented by Mr Roger Joby
  • Next: 6-9 Feb 2023 Live online
  • Also: 20-21 Jun 2023 Live online
  • Also: 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: 9-10 Mar 2023 Live online
  • Also: 25-26 Jul 2023 Live online
  • Also: 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 Feb 2023 Live online
  • Also: 14-16 Jun 2023 Live online
  • Also: 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: 17-18 Apr 2023 Live online
  • Also: 13-14 Jul 2023 Live online
  • Also: 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: 9-10 Feb 2023 Live online
  • Also: 26-29 Jun 2023 Live online
  • Also: 5-6 Oct 2023 Classroom

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online, 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: 24-25 Apr 2023 Live online
  • Also: 19-20 Jul 2023 Live online
  • Also: 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: 14-16 Jun 2023 Live online
  • Also: 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: 17 Mar 2023 Live online
  • Also: 12 Jul 2023 Live online
  • Also: 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: 22-24 Feb 2023 Live online
  • Also: 30 May-1 Jun 2023 Live online
  • Also: 2-4 Oct 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge

New for 2023

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 May 2023 Live online
  • Also: 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: 27-28 Mar 2023 Live online
  • Also: 5-6 Jul 2023 Live online
  • Also: 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: 15-16 May 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2023

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: 17-18 May 2023 Live online
  • Also: 27-28 Sep 2023 Classroom

Process Validation with Qualification

Live online, 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: 13-14 Mar 2023 Live online
  • Also: 19-20 Jun 2023 Classroom
  • Also: 28-29 Sep 2023 Live online
  • Also: 4-5 Dec 2023 Live online

Project Management for Pharma Professionals

Live online, 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: 18-19 May 2023 Live online
  • Also: 28 Sep 2023 Classroom

Quality Management Refresher

New for 2023

Live online, 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: 15-16 May 2023 Classroom
  • Also: 26-29 Sep 2023 Live online

Regulatory Affairs for Support Staff

Live online, 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: 26 Jun 2023 Live online
  • Also: 27 Oct 2023 Live online

Regulatory Strategies for Orphan Drugs

Live online
Focused

This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

  • 6 CPD hours
  • Presented by Joanne Roza
  • and Mr Andrew Willis
  • Next: 9 Mar 2023 Live online
  • Also: 9 Jun 2023 Live online
  • Also: 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: 24 Mar 2023 Live online
  • Also: 25 Jul 2023 Live online
  • Also: 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: 17-18 Apr 2023 Live online
  • Also: 3-4 Jul 2023 Live online
  • Also: 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 Mar 2023 Live online
  • Also: 12 Jul 2023 Live online
  • Also: 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: 6-9 Mar 2023 Live online
  • Also: 13-14 Jul 2023 Live online
  • Also: 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: 19-21 Apr 2023 Classroom
  • Also: 2-4 Aug 2023 Classroom
  • Also: 6-8 Dec 2023 Live online

Successful Medical Writing

Live online, 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: 13-14 Mar 2023 Live online
  • Also: 10-11 Jul 2023 Live online
  • Also: 27-28 Nov 2023 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: 6-7 Feb 2023 Live online
  • Also: 14-15 Jun 2023 Live online
  • Also: 2-3 Oct 2023 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
  • + 3 more
  • Next: 8-10 Feb 2023 Live online
  • Also: 3-5 May 2023 Live online
  • Also: 2-4 Aug 2023 Live online
  • Also: 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: 15-16 Mar 2023 Live online
  • Also: 19-20 Jul 2023 Live online
  • Also: 20-21 Nov 2023 Live online

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

New for 2023

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: 28-29 Mar 2023 Live online
  • Also: 26-27 Jul 2023 Live online
  • Also: 27-28 Nov 2023 Live online

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

New for 2023

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: 24 Apr 2023 Live online
  • Also: 25 Jul 2023 Classroom
  • Also: 4 Dec 2023 Live online

Understanding Pharma Contracts - the Legal and Compliance Lifecycle of a Pharma Product

New for 2023

Live online, Classroom
Focused

A one-day intense review of contracts from each stage of the legal and compliance lifecycle of a pharma product

  • 6 CPD hours
  • Presented by Mrs Rachel Corder
  • Next: 6 Mar 2023 Live online

Update - Latest Position on the New UK Clinical Trial Proposals

New for 2023

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: 28 Feb 2023 Live online
  • Also: 8 Jun 2023 Live online
  • Also: 20 Oct 2023 Live online

US FDA - Understanding Key Factors When Working with the FDA

New for 2023

Live online
Focused

This course has been designed to provide an essential overview of the key factors when working with the FDA.  It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes when making applications to the FDA.

  • 6 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 6-7 Jun 2023 Live online
  • Also: 12-13 Oct 2023 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 Mr Andrew Willis
  • and Marloes van der Geer
  • Next: 20 Feb 2023 Live online
  • Also: 26 Jun 2023 Live online
  • Also: 16 Oct 2023 Live online

Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry

Updated for 2023

Live online
Focused

"What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman

  • 6 CPD hours
  • Presented by Dr Laura Brown
  • Self-paced

The Pharma 'Mini-MBA' On-line Learning Programme

Self-paced

A 14 module self-managed, flexible, online learning course: Focus on the essential MBA theory, practice and technique needed to be a high-performing manager in the field of pharmaceutical with this 14 module course allowing 3 to 4 hours per module to be completed in your own time.

  • Mark Thomas
  • + 6 more
  • Self-paced

Understanding the Pharmaceutical Industry

Self-paced

A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.

  • Mr John Ansell