TOPRA 2025

Our wider stakeholder community Development and deployment of safe and effective treatments and innovative therapies for patients involves extensive collaboration across a broad range of disciplines. As regulatory affairs professionals are drawn from a wide variety of backgrounds – eg, biologists, chemists, pharmacists, physicians, veterinarians, engineers (and many others) – TOPRA members reflect this diversity. Individually, and as a whole, the profession embraces a widespread network of stakeholders around the globe; engaging with healthcare practitioners, professional bodies, academic researchers, patient groups, and charities. At governmental level (both national and international), this extends beyond primary interactions with regulators to include payers, eg, health technology assessment (HTA) and reimbursement. All have common cause in advancing the science of medicines, medical device and diagnostics regulation.

At the forefront of regulatory professionalism In the late 1970s as regulatory affairs began its journey as a separate function in the pharmaceutical arena, people involved in delivering the registration of medicines started to come together to share experiences and develop regulatory training that addressed their specialist needs. In the UK, BIRA (British Institute of Regulatory Affairs), the precursor to TOPRA, was born. In the following decade a companion organisation ESRA (the European Society of Regulatory Affairs) was set up. Ultimately both amalgamated to form TOPRA in 2004 bringing together a significant legacy of delivering symposia, introductory, postgraduate and continuing regulatory education courses focused on European regulatory affairs. The foundation of The Organisation for Professionals in Regulatory Affairs, which incorporated a global remit, was a cornerstone of recognising the professionalisation of its membership. All members demonstrate a commitment •8

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TOPRA 2025 – Aspire | Adapt | Achieve