Regulatory affairs courses, webinars, conferences and meetings

We offer a comprehensive programme of training courses, conferences, meetings and webinars on a wide range of regulatory affairs topics.

Our courses 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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17/07/2024Regulatory 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. OnlineMSCM524O
17/07/2024Regulatory 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.LondonUnited KingdomMSCM52024
06/08/2024Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS0824F
06/08/2024Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.Online BAS0824ON
04/09/2024CRED 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 KingdomCMCF2F24
09/09/2024Registering Biological Biotech & 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.Online MSCM92024O
09/09/2024Registering Biological Biotech & 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.LondonUnited KingdomMSCM924F
11/09/2024Regulatory Careers Live 2024 - UK In-PersonRegulatory Careers Live is your opportunity to meet with potential future employers and get essential advice from some of the most respected and influential leaders in the field of regulatory affairs.LondonUnited KingdomRCL24UK
17/09/2024CRED Regulating Medical Technology and Health SoftwareRegulation on electrical, electronic and software medical devices. OnlineUDHON24
17/09/2024TOPRA in Sweden: Combination ProductsDevelopment of combination products or when drugs and medical devices and/or in vitro medical devices are combined, have its own special challenges. An EU common regulation 536/2014 (also called Clinical Trials Regulation, CTR) applies to clinical trials of medicinal products for humans. A single application for the drug is sent to an EU-wide web portal and database (CTIS) and results, after an EU-wide investigation process, in a national decision. For a combined clinical investigation, the medical device or in vitro medical device must be applied for and approved nationally using different processes in different EU countries. We will hear how different combination products are handled to regulatory approval, about COMBINE, a project to facilitate combined studies, about what rules and guidelines exist and practical experiences. We also get to hear some news about TOPRA. You get the opportunity to meet colleagues in a relaxed and pleasant environment. The meeting is open to anyone who works with and is interested in regulatory affairs.LundSwedenSWESEP24
24/09/2024CRED 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 KingdomSSCS24
25/09/2024CRED 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 KingdomSMPC24F2F
25/09/2024CRED 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 SMPC24O
30/09/2024Veterinary Medicines Symposium 2024The Veterinary Medicines Symposium will concentrate on how we can improve animal health with veterinary medicines by looking at how we collaborate now and in the future, what strategies could be put in place and how we can work together towards new solutions.RotterdamNetherlandsVSYMP2024
30/09/2024Human Medicines Symposium 2024Join us at the forefront of regulatory affairs at our upcoming conference, where industry leaders will delve into the latest developments and challenges facing the sector. This premier event will cover crucial topi, including navigating the changes to the EU Health Technology Assessment (HTA) Regulation, the status of the clinical trials ecosystem in Europe and implementation of the Clinical Trial Regulation (CTR), the impact of artificial intelligence on regulatory professionals and the state of the electronic product information (ePI) pilot project. Listen to and interact with discussions on the future of regulatory affairs with the ever-changing landscape from representatives from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Dutch Medicines Evaluation Board (MEB) and industry. Network with experts and enhance your knowledge to stay ahead of the curve. Don’t miss this opportunity to elevate your expertise and drive forward-thinking strategies in your organisation. Register now to secure your spot!RotterdamNetherlandsHSYMP2024
01/10/2024Medical Devices/IVDs Symposium 2024The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and the clinical requirements.RotterdamNetherlandsMDSYM2024
02/10/2024Regulatory Updates for Start-ups, SMEs and Academia 2024Designed for start-ups, SMEs and Academia, our 2024 regulatory update is a one-day event which will take place on 2 October as part of the 2024 TOPRA Annual SymposiumRotterdamNetherlandsSME2024
07/10/2024Regulatory 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.LondonUnited KingdomMSCM62024F
07/10/2024Regulatory 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.Online MSCM62024O
14/10/2024Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS1024F
14/10/2024Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.Online BAS1024O
15/10/2024CRED 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 KingdomCD24
23/10/2024Post-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 life cycle of a medical device. This course will focus on meeting European requirements.LondonUnited KingdomMSCMD16F
23/10/2024Post-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 life cycle of a medical device. This course will focus on meeting European requirements. OnlineMSCMD16O
31/10/2024Biotech SPIN Webinar: Risk Based Approach To ATMPsFollowing on from the successful series of webinars on ATMPs in 2021, Dr Bridget Heelan returns with an updated presentation on the risk based approach to ATMPs. OnlineBIOOCT24
05/11/2024CRED IVD Regulatory Affairs for Global MarketsIncrease your impact as a regulatory professional and expand your IVD expertise beyond Europe with this two and a half day course.LondonUnited KingdomIVDGM24
05/11/2024CRED IVD Regulatory Affairs for Global MarketsIncrease your impact as a regulatory professional and expand your IVD expertise beyond Europe with this two and a half day course. OnlineIVDGON24
12/11/2024Overview of EU Pharmaceutical Regulatory AffairsModule 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.LisbonPortugalIC22024
19/11/2024Regulatory Strategy for a NAS: Global Clinical DevelopmentRegulatory Strategy for a New Active Substance: Global Clinical Development  is also Module 4 of the MSc and will help you to understand and develop regulatory strategies for all aspects of global clinical research, as well as address practical regulatory issues in this area.BerlinGermanyMSCM42024
19/11/2024Regulatory Strategy for a NAS: Global Clinical DevelopmentRegulatory Strategy for a New Active Substance: Global Clinical Development  is also Module 4 of the MSc and will help you to understand and develop regulatory strategies for all aspects of global clinical research, as well as address practical regulatory issues in this area. OnlineMSCM42024O