Upcoming regulatory affairs courses & webinars

We offer a comprehensive programme of training courses and webinars on a wide range of regulatory affairs topics. Our courses and webinars are delivered by highly regarded experts from industry and government agencies and are suitable for professionals at all stages of their regulatory career.

Read more about the different regulatory affairs course categories and how these relate to your own career.

Our commitment to quality

TOPRA is proud to have provided gold standard training for regulatory affairs professionals for more than 40 years. Our commitment to the profession, to everyone who attends our training and to employers who entrust their staff development to us, is given in our Quality Statement.

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02/09/2025CRED Getting the CMC Dossier RightThis course workshop led by agency and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information in Module 3 of the regulatory dossier. This course will focus on synthetic molecules.LondonUnited KingdomCMCF2F25
02/09/2025CRED Getting the CMC Dossier RightThis course workshop led by agency and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information in Module 3 of the regulatory dossier. This course will focus on synthetic molecules.Online CMCO25
04/09/2025Sponsored Webinar-Understanding the EU CTRFREE SPONSORED WEBINAR - A comprehensive overview of the EU CTR (Regulation (EU) No 536/2014) now that the transition period has fully ended (January 31, 2025), and its current implications for clinical trial conduct across EU/EEA Member States. OnlineSPWBARR25
08/09/2025Design Development and Certification of Medical DevicesThis Masterclass will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices. OnlineMSC142025O
08/09/2025Design Development and Certification of Medical DevicesThis Masterclass will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.LondonUnited KingdomMSCM142025
11/09/2025Sponsored Webinar-Navigating AI Innovation in RAFREE SPONSORED WEBINAR - This webinar will give an overview of how AI is being used in Regulatory Affairs (RA) and where RA professionals can begin effectively navigating the use of AI in their departments. The importance of forming a strong cross functional team and human oversight will also be discussed. OnlineSPWCOR25
16/09/2025Regulatory Requirements for Cell Tissue & Gene TherapiesAdvanced therapy medicinal products (ATMPs), including cell, tissue, and gene therapies, present unique regulatory and scientific challenges. This course explores the complexities of ATMP development and examines the regulatory frameworks in the EU and UK, with comparisons to other major jurisdictions such as the US and Japan. Participants will consider classification, quality, clinical and non-clinical requirements, and the scientific principles that underpin these innovative therapies.LondonUnited KingdomM220225F2F
16/09/2025Regulatory Requirements for Cell Tissue & Gene TherapiesAdvanced therapy medicinal products (ATMPs), including cell, tissue, and gene therapies, present unique regulatory and scientific challenges. This course explores the complexities of ATMP development and examines the regulatory frameworks in the EU and UK, with comparisons to other major jurisdictions such as the US and Japan. Participants will consider classification, quality, clinical and non-clinical requirements, and the scientific principles that underpin these innovative therapies. OnlineM222025O
23/09/2025CRED Successful and Skilful CommunicationSkilful communication and negotiation skills are essential for effective regulatory professionals. Learn to recognise and use different negotiation strategies whilst maintaining trust and respect with complex groups of stakeholders. Develop and deliver impactful presentations and documents that deliver the results you need.LondonUnited KingdomSSCS092025
24/09/2025CRED An Overview of Regulatory Product InformationThis one-day workshop with expert speakers from health authorities and industry will give you an understanding of the strategic development of the regulatory product information in Europe and UK. From company core data sheet to Summary of Product Characteristics (SmPC), Labelling and the Package Leaflet (PL). This is a hands-on workshop covering not just the theoretical approach to creating product information in Europe, but also includes practical exercises for the preparation and implementation of Labelling. You will also hear an overview on what in the pipeline on future digital advancements for labeling.LondonUnited KingdomSMPC25F2F
24/09/2025CRED An Overview of Regulatory Product InformationThis one-day workshop with expert speakers from health authorities and industry will give you an understanding of the strategic development of the regulatory product information in Europe and UK. From company core data sheet to Summary of Product Characteristics (SmPC), Labelling and the Package Leaflet (PL). This is a hands-on workshop covering not just the theoretical approach to creating product information in Europe, but also includes practical exercises for the preparation and implementation of Labelling. You will also hear an overview on what in the pipeline on future digital advancements for labeling.Online SMPC25O
08/10/2025CRED Prescription To Non-Prescription Medicines Switch in EUThe course will provide a comprehensive overview of the regulatory framework on Rx to OTC switch in Europe and the specificities of non-prescription medicines. It will also provide a number of examples and concrete cases to help understanding and turning theory into practice.Online CREDPNP25
14/10/2025CRED Understanding Clinical DevelopmentThis two-day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I through phases II, III and even clinical trials considerations beyond drug marketing approval.Online CD25O
14/10/2025CRED Understanding Clinical DevelopmentThis two-day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I through phases II, III and even clinical trials considerations beyond drug marketing approval.LondonUnited KingdomCD25
20/10/2025Regulation of In-Vitro Diagnostics Medical DevicesThis module primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions.LondonUnited KingdomMSCM1925
20/10/2025Regulation of In-Vitro Diagnostics Medical DevicesThis Masterclass primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions.  MSCM1925O
28/10/2025Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS1025
28/10/2025Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.Online BAS1025ON
30/10/2025CRED Optimising Regulatory Strategies for Orphan DrugsThere are regulatory processes and procedures to expedite approval and access, and to help support the development of medicines for the treatment of rare diseases. This course will provide key information about those regulatory processes and first-hand insights on how to get the best out of them.LondonUnited KingdomOD25
30/10/2025CRED Optimising Regulatory Strategies for Orphan DrugsThere are regulatory processes and procedures to expedite approval and access, and to help support the development of medicines for the treatment of rare diseases. This course will provide key information about those regulatory processes and first-hand insights on how to get the best out of them.Online OD25O
04/11/2025Overview of EU and UK Pharmaceutical Regulatory AffairsThis course covers all aspects of the product development process, and provides a sound overview of EU and UK legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.LondonUnited KingdomIC0112025
04/11/2025Overview of EU and UK Pharmaceutical Regulatory AffairsThis course covers all aspects of the product development process, and provides a sound overview of EU and UK legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies. OnlineIC21125O
10/11/2025Leadership and Strategic Management in Regulatory AffairsThis Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This Masterclass is also Module 10 of the MSc.LondonUnited KingdomMSCM1025
10/11/2025Leadership and Strategic Management in Regulatory AffairsThis Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This Masterclass  is also Module 10 of the MSc.Online MSCM1025O
18/11/2025Data Management and Digitalisation in Regulatory AffairsThis Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance). This Masterclass is also Module 12 of the MSc. OnlineMSCM12225O
18/11/2025Data Management and Digitalisation in Regulatory AffairsThis Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance). This Masterclass is Module 12 of the MSc.LondonUnited KingdomMSCM1225
26/11/2025Essentials of European Medical Device Regulatory AffairsThis course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment.LondonUnited KingdomMDB1125
26/11/2025Essentials of European Medical Device Regulatory AffairsThis course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment.Online MDB1125O
27/11/2025The Awards for Regulatory Excellence 2025Join us at Plaisterers' Hall, London on 27 November for the Awards for Regulatory Excellence to celebrate the achievements of individuals, teams and organisations in the regulatory affairs community.LondonUnited KingdomAWARDS2025
02/12/2025Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impaally debate the commercial implications and the impact of the regulations on product stakeholders.LondonUnited KingdomMDM202025