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Discover the strategies and insights needed to navigate orphan drug regulations effectively. This course provides essential guidance on regulatory processes that accelerate development and access, along with first-hand advice on how to maximise opportunities for rare disease medicines.
When: November 16, 2027
Where: Online
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Develop a clear understanding of how effective clinical trials are designed, drawing on practical perspectives from regulators and industry. This course addresses key considerations for planning and conducting clinical trials from phase I through phases II and III, and for supporting regulatory expectations beyond initial marketing approval.
When: November 9, 2027
Where: Online
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Navigating the Rx to OTC switch process in Europe takes more than regulatory knowledge. It requires strategy, market awareness and the ability to turn theory into action. This course equips you with all three, combining a thorough grounding in EU frameworks with practical case studies so you can apply what you learn from day one.
When: October 7, 2027
Where: Online
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Ensure your CMC submissions meet current standards with this course, providing you with practical guidance on data expectations, common pitfalls, and best practices for preparing Module 3 of Marketing Authorisation Applications for synthetic molecules. Gain the insights needed to enhance compliance and streamline the approval process.
When: September 28–29, 2027
Where: London
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Master the strategic development and practical implementation of regulatory product information in Europe and the UK through this hands-on course, featuring expert insights on SmPCs, labelling, and upcoming digital innovations.
When: September 14, 2027
Where: Online
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Gain a comprehensive introduction to the pharmaceutical development pathway and the EU and UK regulatory systems that support it, with insight into the essential contribution regulatory affairs makes across the lifecycle of a medicine.
When: July 14, 2027
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Gain a clear understanding of Clinical Trial Application (CTA) requirements across the EU and beyond, including the latest updates on the EU Clinical Trial Regulation 536/2014 and CTIS. Learn practical strategies for managing CTAs effectively through expert-led, interactive sessions.
When: June 2–3, 2027
Where: London
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Gain a clear understanding of Clinical Trial Application (CTA) requirements across the EU and beyond, including the latest updates on the EU Clinical Trial Regulation 536/2014 and CTIS. Learn practical strategies for managing CTAs effectively through expert-led, interactive sessions.
When: June 2–3, 2027
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Master the communication and negotiation skills every regulatory professional needs. Learn to influence stakeholders, navigate complex interactions, and deliver presentations and documents that achieve results.
When: May 25, 2027
Where: London
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This course provides a clear overview of the EU variations regulation, with a focus on grouping and work-sharing procedures. Attendees will explore how to navigate the categorisation guidelines and discuss other critical actions needed for effective lifecycle management.
When: April 20–21, 2027
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This course is designed for individuals involved in developing European regulatory strategies for projects or wishing to gain the knowledge and skills to contribute to regulatory strategies.
When: December 8–9, 2026
Where: London
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Build regulatory strategies that protect brands and sustain market success. This Masterclass focuses on the real-world regulatory decisions that underpin effective product commercialisation and lifecycle management, enabling you to deliver confident, commercially aligned regulatory advice from development through to the marketplace. This course is also Module 6 of the MSc... Details
When: December 1–3, 2026
Where: London
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Build regulatory strategies that protect brands and sustain market success. This Masterclass focuses on the real-world regulatory decisions that underpin effective product commercialisation and lifecycle management, enabling you to deliver confident, commercially aligned regulatory advice from development through to the marketplace.
When: December 1–3, 2026
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Module 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.
When: November 18–20, 2026
Where: London
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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.
When: November 18–20, 2026
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A two-day course that strengthens your ability to manage regulatory projects, lead teams and deliver high-quality regulatory documents.
When: November 12–13, 2026
Where: Online
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Discover the strategies and insights needed to navigate orphan drug regulations effectively. This course provides essential guidance on regulatory processes that accelerate development and access, along with first-hand advice on how to maximise opportunities for rare disease medicines.
When: November 10, 2026
Where: Online
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Navigating the Rx to OTC switch process in Europe takes more than regulatory knowledge. It requires strategy, market awareness and the ability to turn theory into action. This course equips you with all three, combining a thorough grounding in EU frameworks with practical case studies so you can apply what you learn from day one.
When: November 3, 2026
Where: Online
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Gain a comprehensive introduction to the pharmaceutical development pathway and the EU and UK regulatory systems that support it, with insight into the essential contribution regulatory affairs makes across the lifecycle of a medicine. This course is also Module 0 of the MSc programme.
When: November 3–5, 2026
Where: Vienna
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Gain a comprehensive introduction to the pharmaceutical development pathway and the EU and UK regulatory systems that support it, with insight into the essential contribution regulatory affairs makes across the lifecycle of a medicine.
When: November 3–5, 2026
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Small and medium sized companies (SMEs), academia and start-ups face different regulatory challenges when developing the life science products of the future that meet patients’ needs. This Symposium stream will explore the latest regulatory news, provide updates on recent changes, and highlight the support available for SMEs, academia and start-ups. In 2026, the stream will be extended to 1.5 days, giving you the opportunity to take part in more sessions, join deeper discussions,... Details
When: October 20–21, 2026
Where: Utrecht
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Join us at the forefront of regulatory affairs at the TOPRA Human Medicines Symposium 2026. Hear from industry leaders, engage in interactive discussions, and explore the latest developments and challenges shaping the sector from both regulatory and industry perspectives. Expand your expertise and take away strategies to drive innovation in your... Details
When: October 19–21, 2026
Where: Utrecht
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The 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 (IVDs) needs to keep up to date with both the new EU regulations and the clinical requirements. In 2026, the programme will increase to three full days, providing even more opportunities to learn and... Details
When: October 19–21, 2026
Where: Utrecht
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