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.

Download our Courses & Conferences calendar for 2021 (PDF)

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26/01/2021An Overview of the Chinese Medical Device RegulationsThis webinar will outline the regulatory environment for medical devices and give an overview on the pre-market and post-market processes in China. OnlineWEBMDCN
04/02/2021Gene Therapy: Fundamentals of the FDA's Regulatory FrameworkThis webinar will look at the fundamentals of the FDA’s regulatory framework for the development of gene therapy products and discuss key topics, precedence, and current thinking in how to approach gene therapy development from a regulatory perspective. OnlineWEBFDAGT
04/02/2021Essentials of European Veterinary Regulatory AffairsThe world of veterinary regulatory affairs can be a confusing and complex place, particularly if you have no formal veterinary or regulatory affairs background. The purpose of this course is to provide you with a clear and concise understanding of the role played by regulatory affairs in obtaining and maintaining marketing authorisation for veterinary medicinal products. OnlineVETBAS21
08/02/2021Drug–Device Combinations and Other TechnologiesModule 18 of the MSc and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product. OnlineMC1820210
22/02/2021Clinical Trial Regulation in Australia & New ZealandThis webinar will enable you to understand the regulatory requirements for the approval of clinical trials in Australia and New Zealand. OnlineWEBCTAUSNZ
24/02/2021CRED Practical Document Writing and ManagementA skills-based course on the theory and practice of writing optimal regulatory documents and communications for those working in the pharmaceutical industry. OnlineDOC2021
03/03/2021US Regulation of Medical DevicesModule 21 of the MSc and Masterclass: this will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. OnlineMC212021O
08/03/2021CRED 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. OnlineORPHAN21
17/03/2021CRED European IVD Regulatory AffairsThis two and a half day course will cover all the key topics and areas of responsibility for professionals taking on the Person Responsible for Regulatory Compliance role under the IVDR. It will also provide comprehensive information for anyone responsible for implementing the necessary changes to be ready when the IVDR comes into force. OnlineIVD121
22/03/2021Registering Biological Biotech and Advanced Therapy ProductsModule 9 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation and scientific principles underpinning development of biological, biotechnology and advanced therapy products, which provide challenges with their inherent complexities. The module includes consideration of the data requirements for clinical trial applications and marketing applications. OnlineMSCM921O
25/03/2021Essentials of European Pharmaceutical Regulatory AffairsThis course will provide an overview of pharmaceutical regulatory affairs in a relaxed and interactive environment. OnlineBAS2503
08/04/2021Webinar: Regulatory Career Path DevelopmentThis webinar will provide an overview of how regulatory affairs fits into the bigger picture of the drug development process and public health, as well as exploring different regulatory career options to help delegates build a durable regulatory career pathway and fulfil their potential. OnlineWEBREGDEV
14/04/2021The Spring Introductory Course (Pharmaceuticals)Module 0 of the MSc:  This course covers all aspects of the product development process, and provides a sound overview of EU legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies. OnlineIC12021
21/04/2021Leadership and Strategic Management in Regulatory AffairsModule 10 of the MSc and Masterclass: This 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.BrusselsBelgiumMSCM1021
21/04/2021Leadership and Strategic Management in Regulatory AffairsModule 10 of the MS and Masterclass: This 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. OnlineMSCM1021O
29/04/2021Essentials of European Medical Device Regulatory AffairsThis online course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment. OnlineMDBAS21
29/04/2021Essentials of European Medical Device Regulatory AffairsThis face-to-face course will provide an overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment. United KingdomMDBAS21F2F
06/05/2021Essentials of European Pharmaceutical Regulatory AffairsThis online course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment. OnlineBAS0605
06/05/2021Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.BrusselsBelgiumBAS0605F2F
12/05/2021CRED 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 KingdomCOMM211
26/05/2021CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical. OnlineVAR21
26/05/2021CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical.LondonUnited KingdomVAR21F2F
01/06/2021Regulation of In Vitro Diagnostics Medical DevicesModule 19 of the MSc and 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.LondonUnited KingdomMC192021
01/06/2021Regulation of In Vitro Diagnostics Medical DevicesModule 19 of the MSc and 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.OnlineOnlineMC1920210
09/06/2021CRED Project Management for Regulatory Affairs ProfessionalsA two-day, skills-based course on the theory and practice of managing project teams to produce optimal regulatory documents and communications for those working in the pharmaceutical industry.LondonUnited KingdomPM21
11/06/2021CRED An Overview of Regulatory Product InformationThis one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.LondonUnited KingdomSMPC21
11/06/2021CRED An Overview of Regulatory Product InformationThis one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view. OnlineSMPC21VIR
23/06/2021Compiling Successful Clinical Trial ApplicationsThis online course will equip you with the key knowledge on Clinical Trials applications you need as a regulatory professional.OnlineOnlineCT21
23/06/2021Compiling Successful Clinical Trial ApplicationsThis face-to-face course will equip you with the key knowledge on Clinical Trials applications you need as a regulatory professional.LondonUnited KingdomCT21F2F
30/06/2021Strategic Planning in Regulatory AffairsModule 1 of the MSc and Masterclass: This Masterclass will help you understand the practical and strategic aspects of global regulatory affairs, and enable you to develop your knowledge and skills to provide advice to your company to help develop a regulatory strategy.RotterdamNetherlandsMSCM12021