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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07/02/2023Compiling 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.BrusselsBelgiumCT23
07/02/2023Compiling Successful Clinical Trial ApplicationsThis course will equip you with the key knowledge on clinical trials applications you need as a regulatory professional.OnlineOnlineCT23O
14/02/2023MedTech SPIN Webinar: EU-MDR New Rule 21In this webinar, Theresa Jeary will shed some light on rule 21, its intent and how manufacturers can develop an effective regulatory strategy to successfully navigate conformity assessments and ensure Annex I to Directive 2001/83/EC requirements are met. OnlineMEDTJAN23
14/02/2023TOPRA in Sweden: Medical Devices-Combination ProductsThis evening is an excellent opportunity to discuss experiences with the new regulations MDR and IVDR which were fully implemented from 26 May 2021 and 26 May 2022 respectively. How have they affected the work at the Medical Products Agency and the companies? How have they affected clinical trials? What applies to combination products, when a medicine contains a medical device component (Article 117)? And what does consultation mean for a medical device with medicinal substance? Open to anyone working with and interested in regulatory issues for pharmaceuticals and medical devices.UppsalaSwedenSWEFEB23
15/02/2023Sponsored: Ensuring promotional materials' compliance in EUFREE SPONSORED WEBINAR -  In this webinar, Insuvia will discuss the granularity of requirements in various EU markets and how to plan compliance strategy to navigate the differences. We will explore what constitutes promotion and how to avoid common pitfalls in decision making, especially when global/regional materials and communication plans are being adapted to local markets. OnlineSPWINSUV23
22/02/2023Essentials 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 authorisations for veterinary medicinal products.LondonUnited KingdomVETBAS23
22/02/2023Essentials 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 authorisations for veterinary medicinal products.Online VETBAS23O
22/02/2023Sponsored: Comparison of China DMF with EU and USFREE SPONSORED WEBINAR -  This webinar is about China Drug Master Filing (DMF) versus EU and U.S DMF. Accestra will provide an overview of the DMF registration systems covering Active Pharmaceutical ingredients (APIs), Excipients & Packaging Materials. Thanks to global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF, CEP and Japanese DMF requirements. However, local regulations and differences still exists and it is essential to understand these to minimize risks and issues further down the line with DMF submissions to China CDE & NMPA. OnlineSPOWEBAS22
15/03/2023Regulatory Strategy for a New Active Substance NonclinicalModule 2 of the MSc and Masterclass: This Masterclass will give delegates an understanding of the practical and legislative requirements for the nonclinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations.  MSCM223O
15/03/2023Regulatory Strategy for a New Active Substance NonclinicalModule 2 of the MSc and Masterclass: This Masterclass will give delegates an understanding of the practical and legislative requirements for the nonclinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations.LondonUnited KingdomMSCRAM223
21/03/2023Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS0323
28/03/2023The 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.BracknellUnited KingdomIC22023P
18/04/2023Regulation 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 KingdomMDM1923
18/04/2023Regulation 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.  MSCM1923O
25/04/2023CRED Regulatory Document Writing and ManagementSkills based course on the theory and practice of writing regulatory documents and communications for optimal impact and effectiveness.LondonUnited KingdomDW23
25/04/2023CRED Regulatory Document Writing and ManagementSkills based course on the theory and practice of writing regulatory documents and communications for optimal impact and effectiveness.OnlineUnited KingdomDW23O
03/05/2023CRED 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.Online PM23O
03/05/2023CRED 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 KingdomPM23
09/05/2023Leadership and Strategic Management in Regulatory AffairsThis course was previously advertised for 8th-10th May, but has been changed due to the new UK Bank Holiday. Module 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.OnlineUnited KingdomMSCM1023O
09/05/2023Leadership and Strategic Management in Regulatory AffairsThis course was previously advertised for 8th-10th May, but has been changed due to the new UK Bank Holiday. Module 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.LondonUnited KingdomMSCRAM1023
15/05/2023Registering 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 KingdomMSCM92023
15/05/2023Registering 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.  MSCM923O
23/05/2023CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical. OnlineLCM23O
23/05/2023CRED 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 KingdomLCM23
07/06/2023Regulation of Electrical, Electronic and Software DevicesModule 20 of the MSc and Masterclass: This 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 impact of the regulations on product stakeholders.LondonUnited KingdomMDM202022
07/06/2023Regulation of Electrical, Electronic and Software DevicesModule 20 of the MSc and Masterclass: This 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 impact of the regulations on product stakeholders.  MSCM2023O
13/06/2023CRED Regulatory Update: Veterinary Variations in the EUThis is a comprehensive overview of how to prepare and submit variations to VMP marketing authorisations. It provides an update on the latest changes and advice on best practice for experienced regulatory professionals. OnlineVETVAR23
14/06/2023Essentials 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 KingdomMEDBAS0623
22/06/2023Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.BrusselsBelgiumBAS0523
27/06/2023The 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 KingdomMD2023