Scheduled In-house

Pharmaceutical Training Courses

By attending our pharmaceutical training courses you will gain access to industry, academic and regulatory authority experts with a wealth of experience.  Our in-person events also provide the opportunity to network and discuss the challenges and developments with our speakers and 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 the industry. Our pharmaceutical training courses have been designed to focus on the latest developments and best practices, presented by industry experts on key topics across the pharmaceutical lifecycle, including clinical, regulatory, manufacturing, GxP, pharmacovigilance, medical writing and biopharma.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

CAPA (Corrective and Preventative Action)

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Pharmaceutical Regulatory Affairs in the Middle East

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

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz

Understanding Pharmacovigilance Regulations in APAC

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours Focused
  • Presented by Ms Marylene Zhan
  • + 4 more

Best Practice for Writing Effective SOPs

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

A Practical Guide to Producing and Maintaining the PSMF

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 Focused
  • Presented by Dr Graeme Ladds

MBA Strategic Thinking for Pharma and Biopharma Professionals

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

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Clinical Trial Monitoring

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown

Pharmaceutical Regulatory Affairs in China

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

  • 12 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer

Data Integrity Auditor Master Class

During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

ICH Q9(R1) Quality Risk Management (QRM)

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • Presented by Bruce Davis

Clinical Trial Regulatory Requirements

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 a brief review of key FDA requirements.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

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

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 Focused
  • Presented by Dr Graeme Ladds

Drafting and Negotiating Clinical Trial Agreements

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 Focused

Drug Discovery: A Step-by-Step Introduction

This drug discovery training 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 Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug 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 drug discovery project.

  • 12 CPD hours Focused
  • Presented by Dr Peter A. Lowe

An Essential Overview of the Pharmaceutical and Biotech Industries

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Regulatory Affairs for Support Staff

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 Focused
  • Presented by Norah Lightowler

Consultative Selling for Pharma Professionals

In this two-day, selling for pharma professionals training course, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.

  • 12 CPD hours
  • Presented by Robert Hersowitz

Understanding and Interpreting the Proposed Changes to EU GMP Annex 11

This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.

  • 3 CPD hours Focused
  • Presented by Dr Bob McDowall

The Pharma Mini MBA

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 Focused
  • Presented by Dr Laura Brown
  • + 2 more

An Essential Overview of Pharmacovigilance

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds

Pharmacovigilance QMS & Inspection Preparation

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

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds

EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

An Introduction to Pharmaceutical Packaging

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 Focused
  • Presented by Chris Penfold

Process Validation with Qualification

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 Focused
  • Presented by Bruce Davis

EU Proposed Pharmaceutical Legislation Changes

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation. This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

  • 3 CPD hours Focused
  • Presented by Norah Lightowler

Clinical Quality Management Systems

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

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Variations to Marketing Authorisations

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 Focused
  • Presented by Andrew Willis

Delivery of Biologics to the Nasal Cavity

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

  • 3 CPD hours Focused
  • Presented by Dr Irene Rossi
  • + 3 more

Advanced Pharmacovigilance

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 Focused
  • Presented by Dr Graeme Ladds

Risk Management for Pharma and Biopharma Professionals

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 Focused
  • Presented by Dr Laura Brown

EU Pharmaceutical Regulations & Strategy

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler

Clinical Research - A Different Approach to Successful Project Delivery

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

  • 6 CPD hours
  • Presented by Roger Joby

The FDA Drug Approval Process

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Pharmacovigilance

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

  • 18 CPD hours Focused
  • Presented by Dr John Parkinson
  • + 3 more

Pharmaceutical Regulatory Affairs in Asia

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 Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer

Effective Training Skills in the Pharma Industry

This interactive training skills and processes in pharma course is 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 Focused
  • Presented by Dr Laura Brown

Practical Requirements of the Arab Pharmacovigilance Guidelines

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

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds

Project Management for Pharma Professionals

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 Focused
  • Presented by Dr Laura Brown

Pharmaceutical Regulatory Affairs in Africa

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 Focused
  • Presented by Makram Nehme
  • and Salma Ismail

Pharmaceutical Development of ATMPs

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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 Focused
  • Presented by Dr John Price

Cosmetovigilance

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). 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 Focused
  • Presented by Dr Graeme Ladds

Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry

This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries. "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 Focused
  • Presented by Dr Laura Brown

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

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 Focused
  • Presented by Anna Harrington-Morozova

Biotechnology for the Non-Biotechnologist

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

  • 18 CPD hours Focused
  • Presented by Mardon McFarlane
  • + 6 more

Regulatory Strategies for Orphan Drugs

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

  • 6 CPD hours Focused
  • Presented by Andrew Willis
  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Development of Combination Products: Critical Interactions

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Pharmaceutical Regulatory Affairs in the Middle East

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

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz

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

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 Focused
  • Presented by Andrew Willis

Effective Technical Writing & Editing

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

  • 6 CPD hours Focused
  • Presented by Barbara Grossman

Signal Detection and Regulatory Expectations

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 Focused
  • Presented by Dr Graeme Ladds

GCP and Clinical Research Update - Hot Inspection Topics

This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Pharmaceutical Regulatory Affairs in China

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

  • 12 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer

New EU GMP Annex 1: Compliant Aseptic Operations

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours
  • Presented by Mustafa Edik

Agile Leadership for Pharma and Biopharma Professionals in a hybrid world

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 Focused
  • Presented by Dr Laura Brown

The Common Technical Document

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Drafting Commercial Contracts for the Pharmaceutical Industry

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

  • 12 CPD hours Focused
  • Presented by Dr Ben Thomas
  • + 8 more

An Essential Overview of the Medical Device Industry

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 Focused
  • Presented by Dr David Jefferys
  • and Theresa Jeary

Understanding Pharmacovigilance Regulations in APAC

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours Focused
  • Presented by Ms Marylene Zhan
  • + 4 more

Biosimilars

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Pharmacovigilance Aspects of Licensing Agreements

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

  • 6 CPD hours Focused
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds

Smart Packaging and Electronic Patient Information

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 Focused
  • Presented by Mr Graham Howieson

The Common Technical Document (CTD) Submission in the MENA Region

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

  • 6 CPD hours
  • Presented by Mohammad Fat'hy Elnadi

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

  • Presented by Greg Thay

Clinical Trial Monitoring

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown

Stability Testing of Pharmaceuticals and Biopharmaceuticals

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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

Metrics and Earned Value in Clinical Research Projects

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

  • 4 CPD hours Masterclass
  • Presented by Roger Joby

An Essential Overview of Medical Information

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 Focused
  • Presented by Dr Graeme Ladds

US FDA - Understanding Key Factors When Working with the FDA

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

  • 6 CPD hours Focused
  • Presented by Andrew Willis

European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications

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.

  • Focused
  • Presented by Dr Graeme Ladds

Effective Technology Transfer

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

  • 12 CPD hours Focused
  • Presented by Bruce Davis

Understanding Active Pharmaceutical Ingredients (APIs)

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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

Best Practice for Writing Effective SOPs

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Drafting and Negotiating Clinical Trial Agreements

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 Focused

CAPA (Corrective and Preventative Action)

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Data Integrity and Document Management

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 Focused
  • Presented by Dr Laura Brown

Root Cause Analysis and Critical Thinking

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 Focused
  • Presented by Dr Laura Brown

Understanding Computer System Validation (CSV)

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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

Data Integrity Auditor Master Class

During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Positive Persuading and Influencing Skills for Pharma Professionals

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

  • 12 CPD hours Focused
  • Presented by Robert Hersowitz

The Leadership and Management Summer School for Pharma Professionals

Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure, is probably one of the most challenging managerial roles of any industry today. This 5-day Summer School has been especially designed to help you transcend these challenges by training you to become equipped to see the bigger picture in all aspects of your role.

  • 30 CPD hours Intensive
  • Presented by Dr Laura Brown
  • + 3 more

The Pharma Mini MBA

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 Focused
  • Presented by Dr Laura Brown
  • + 2 more

A Practical Guide to Writing Risk Management Plans (RMPs)

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

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds

A Practical Guide to Producing and Maintaining the PSMF

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 Focused
  • Presented by Dr Graeme Ladds

An Essential Overview of Pharmacovigilance

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds

An Essential Overview of the Pharmaceutical and Biotech Industries

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Clinical Trial Regulatory Requirements

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 a brief review of key FDA requirements.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Consultative Selling for Pharma Professionals

In this two-day, selling for pharma professionals training course, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.

  • 12 CPD hours
  • Presented by Robert Hersowitz

Understanding and Interpreting the Proposed Changes to EU GMP Annex 11

This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.

  • 3 CPD hours Focused
  • Presented by Dr Bob McDowall

Advanced Pharmacovigilance

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 Focused
  • Presented by Dr Graeme Ladds

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.

  • Presented by Professor John E. Harrison

EU Proposed Pharmaceutical Legislation Changes

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation. This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

  • 3 CPD hours Focused
  • Presented by Norah Lightowler

Drug Discovery: A Step-by-Step Introduction

This drug discovery training 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 Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug 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 drug discovery project.

  • 12 CPD hours Focused
  • Presented by Dr Peter A. Lowe

Clinical Quality Management Systems

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

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Process Validation with Qualification

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 Focused
  • Presented by Bruce Davis

Regulatory Affairs for Support Staff

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 Focused
  • Presented by Norah Lightowler

An Introduction to Pharmaceutical Packaging

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 Focused
  • Presented by Chris Penfold

Biotechnology for the Non-Biotechnologist

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

  • 18 CPD hours Focused
  • Presented by Dr Adekunle Onadipe
  • + 5 more

ICH Q9(R1) Quality Risk Management (QRM)

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • Presented by Bruce Davis

Project Management for Pharma Professionals

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 Focused
  • Presented by Dr Laura Brown

Pharmacovigilance QMS & Inspection Preparation

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

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds

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

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 Focused
  • Presented by Dr Graeme Ladds

Effective Technical Writing & Editing

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

  • 6 CPD hours Focused
  • Presented by Barbara Grossman

Biosimilars

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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 Focused
  • Presented by Dr John Price

MBA Strategic Thinking for Pharma and Biopharma Professionals

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

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Development of Combination Products: Critical Interactions

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

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 Focused
  • Presented by Anna Harrington-Morozova

Clinical Research - A Different Approach to Successful Project Delivery

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

  • 6 CPD hours
  • Presented by Roger Joby

Effective Technology Transfer

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

  • 12 CPD hours Focused
  • Presented by Bruce Davis

Regulatory Strategies for Orphan Drugs

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

  • 6 CPD hours Focused
  • Presented by Andrew Willis

Risk Management for Pharma and Biopharma Professionals

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 Focused
  • Presented by Dr Laura Brown

Delivery of Biologics to the Nasal Cavity

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

  • 3 CPD hours Focused
  • Presented by Dr Irene Rossi
  • + 3 more

Understanding Pharmacovigilance Regulations in APAC

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours Focused
  • Presented by Ms Marylene Zhan
  • + 4 more

A Practical Guide to Writing Risk Management Plans (RMPs)

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

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds

Pharmaceutical Regulatory Affairs in Asia

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 Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer

Pharmacovigilance

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

  • 18 CPD hours Focused
  • Presented by Dr John Parkinson
  • + 3 more

A Practical Guide to Producing and Maintaining the PSMF

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 Focused
  • Presented by Dr Graeme Ladds

Effective Training Skills in the Pharma Industry

This interactive training skills and processes in pharma course is 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 Focused
  • Presented by Dr Laura Brown

Pharmaceutical Development of ATMPs

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

EU Pharmaceutical Regulations & Strategy

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler

Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry

This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries. "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 Focused
  • Presented by Dr Laura Brown

Cosmetovigilance

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). 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 Focused
  • Presented by Dr Graeme Ladds

Data Integrity Auditor Master Class

During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik
  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Practical Requirements of the Arab Pharmacovigilance Guidelines

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

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds

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

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 Focused
  • Presented by Andrew Willis

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

  • Presented by Greg Thay

European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications

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.

  • Focused
  • Presented by Dr Graeme Ladds

Smart Packaging and Electronic Patient Information

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 Focused
  • Presented by Mr Graham Howieson

Drafting and Negotiating Clinical Trial Agreements

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 Focused

The Pharma Mini MBA

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 Focused
  • Presented by Dr Laura Brown
  • + 2 more

An Essential Overview of the Medical Device Industry

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 Focused
  • Presented by Dr David Jefferys
  • and Theresa Jeary

EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

  • 12 CPD hours Focused
  • Presented by Dr Laura Brown

Positive Persuading and Influencing Skills for Pharma Professionals

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

  • 12 CPD hours Focused
  • Presented by Robert Hersowitz

Stability Testing of Pharmaceuticals and Biopharmaceuticals

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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

Signal Detection and Regulatory Expectations

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 Focused
  • Presented by Dr Graeme Ladds

Agile Leadership for Pharma and Biopharma Professionals in a hybrid world

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 Focused
  • Presented by Dr Laura Brown

Understanding Active Pharmaceutical Ingredients (APIs)

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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

Pharmaceutical Regulatory Affairs in Africa

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 Focused
  • Presented by Makram Nehme
  • and Salma Ismail

Drafting Commercial Contracts for the Pharmaceutical Industry

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

  • 12 CPD hours Focused
  • Presented by Alex Denoon
  • + 10 more

GCP and Clinical Research Update - Hot Inspection Topics

This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Metrics and Earned Value in Clinical Research Projects

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

  • 4 CPD hours Masterclass
  • Presented by Roger Joby

Root Cause Analysis and Critical Thinking

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 Focused
  • Presented by Dr Laura Brown

The Common Technical Document

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Understanding Computer System Validation (CSV)

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 Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

New EU GMP Annex 1: Compliant Aseptic Operations

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours
  • Presented by Mustafa Edik

US FDA - Understanding Key Factors When Working with the FDA

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

  • 6 CPD hours Focused
  • Presented by Andrew Willis

Pharmacovigilance Aspects of Licensing Agreements

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

  • 6 CPD hours Focused
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds

Successful Medical Writing – from Protocol to CTD

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 Focused

Variations to Marketing Authorisations

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 Focused
  • Presented by Andrew Willis

The Common Technical Document (CTD) Submission in the MENA Region

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

  • 6 CPD hours
  • Presented by Mohammad Fat'hy Elnadi

An Essential Overview of Medical Information

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 Focused
  • Presented by Dr Graeme Ladds

The FDA Drug Approval Process

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

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Clinical Trial Monitoring

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.

  • 12 CPD hours
  • Presented by Dr Laura Brown

Biotechnology for the Non-Biotechnologist

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

  • 18 CPD hours Focused
  • Presented by Mardon McFarlane
  • + 6 more

Data Integrity and Document Management

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 Focused
  • Presented by Dr Laura Brown

Project Management for Pharma Professionals

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 Focused
  • Presented by Dr Laura Brown

Pharmaceutical Regulatory Affairs in the Middle East

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

  • 12 CPD hours Focused
  • Presented by Heba Hashem
  • and Ilona Putz

Advanced Pharmacovigilance

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 Focused
  • Presented by Dr Graeme Ladds

Pharmaceutical Regulatory Affairs in China

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

  • 12 CPD hours Focused
  • Presented by Dr Alan Chalmers
  • and Monica Dressler-Meyer

Best Practice for Writing Effective SOPs

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

CAPA (Corrective and Preventative Action)

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

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Understanding and Interpreting the Proposed Changes to EU GMP Annex 11

This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.

  • 3 CPD hours Focused
  • Presented by Dr Bob McDowall