TOPRA 2025

Healthcare regulatory affairs is a multi-faceted community connecting at all levels: locally, nationally and across the world. TOPRA engages across a broad membership and connects with numerous stakeholder networks involved with medicines, medical device and diagnostics regulation, providing a unique perspective and offering a neutral forum for stakeholder discussions. Our members are the core to TOPRA’s community. Extending beyond our membership is a broader community of individuals from agencies and industry and other stakeholders who engage with TOPRA – as speakers, authors, advisers, supporters and patients. Their collective knowledge, expertise and experience is invaluable to our members. Conversely, our members’ knowledge, expertise and experience is beneficial to our stakeholders in the endeavour to support healthcare providers and practitioners deliver better, safer, more innovative treatments to patients. At a global level, the increasing convergence of regulatory affairs offers opportunities for regulatory professionals to get involved in international partnerships, both governmental and non-governmental, contributing to the widespread improvement of public health and helping build regulatory capacity in developing countries. Role of regulatory affairs Regulatory affairs professionals are at the forefront of protecting the public, helping to ensure that any medicine, medical device or in vitro diagnostic brought to the clinic is safe and effective. Regulatory affairs covers both regulators and regulated – whichever perspective they have, the priority is ensuring innovative treatments go through the regulatory process in a timely way, establishing benefit–risk profiles, meeting unmet patient needs, eg, for rare conditions, and access. Regulatory professionals contribute to all stages of the process – from initial clinical trials, to large-scale global clinical development, registration and approval to post- marketing surveillance of drug products and devices.

At the heart of healthcare Regulatory affairs delivering safe and effective healthcare systems

6

TOPRA 2025 – Aspire | Adapt | Achieve