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.

Start dateTitleDescriptionCityCountry
22/04/2020Optimize Your Medical Device Regulatory ProcessesLearn how to ensure sustained compliance with the EU-MDR and IVDR utilizing end-to-end regulatory operations automation. OnlineWEBINSTM20
23/04/2020CRED Successfully Navigating European GMO RegulationsLearn to navigate the EU GMO legislative framework and implementation for successful clinical trial submissions. The course will will also discuss Canadian requirements. This online course includes presentations that can be accessed on demand and a live question-and-answer panel session and case study presentation. OnlineBIOTECH20
28/04/2020CRED Drug-device Combination Products: Major Changes Ahead!Are you developing new pharmaceutical products which include (or are they provided with) any type of administration device? If yes, are you fully aware of the impact the new EU Medical Device Regulation on MAAs will have? This course will explain the current state of developments as MAHs prepare for the new requirements. OnlineDRUG20
29/04/2020Essentials of In-Vitro Diagnostics Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs for IVDs in a relaxed and interactive environment. OnlineIVDBAS20
06/05/2020Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment. OnlineBAS0520
14/05/2020CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical. OnlineVAR20
03/06/2020Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance. OnlineMC152020
10/06/2020CRED 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 KingdomCD20
23/06/2020Essentials of European Medical Device Regulatory AffairsThis course will provide a basic, comprehensive overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment. OnlineMEDBAS620
25/06/2020CRED 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. OnlineORPHAN20
01/07/2020Regulatory Strategy from Development to the MarketplaceThis Masterclass is also Module 6 of the MSc regulatory Affairs, and will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from the development stages to registration and throughout the product lifecycle. You will explore and critically debate the regulatory issues likely to arise prior to and during commercialising of products in order to be able to provide effective advice on such situations.CheshamUnited KingdomMSCM620
08/07/2020The Medical Device Introductory Course(Module 13 of the MSc Medical Devices) Providing those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU.LondonUnited KingdomINTROMD20
06/08/2020Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS0820
02/09/2020Post-Market Surveillance and Vigilance for Medical DevicesThis Masterclass is also Module 16  of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. This course will focus on meeting European requirements.LondonUnited KingdomMC162020
08/09/2020CRED Project Management for Regulatory Affairs ProfessionalsA two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.LondonUnited KingdomPM20
22/09/2020CRED 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 and provide a brief introduction to biologics.LondonUnited KingdomCMC20
23/09/2020Regulatory Strategy for Established Active SubstancesThis Masterclass is also Module 7 of the MSc and is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of the strategic issues to be considered in relation to medicines containing established active substances, including; line extensions, generics and the relevant aspects for OTC products. It will allow them to examine the regulatory requirements imposed on these substances.DublinIrelandMSCM72020
22/10/2020CRED Understanding Digital Health and Electronic ProductsRegulation of electrical, electronic and software medical devices.LondonUnited KingdomEE20
04/11/2020Regulatory and Related Activities Through the LifecycleThis Masterclass is also Module 17 of the MSc Regulatory Affairs and will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures.LondonUnited KingdomMC172020
12/11/2020Essentials of European Medical Device Regulatory AffairsThis course will provide a basic, comprehensive overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment.DublinIrelandMDBASIRE20
17/11/2020The Autumn Introductory Course (Pharmaceuticals)An Introduction to Pharmaceutical Regulatory Affairs (Module 0 of the MSc Regulatory Affairs). 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.BerlinGermanyIC22020
24/11/2020Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS1120
25/11/2020Regulatory Control of Clinical OperationsThis Masterclass is also Module 5 of the MSc and  will provide you with an understanding of the practical and regulatory aspects of global clinical research, in order to offer effective advice on the regulatory issues likely to arise during clinical programmes.CheshamUnited KingdomMSCM52020
31/12/2099Registered Scientist Registration   RSCI