TOPRA 2025

CASE STUDY Helping build regulatory capacity

TOPRA is committed to supporting regulatory agencies in low-income countries to develop regulatory capacity. The creation of the new African Medicines Agency (AMA) is a significant step forwards but it can only be successful if there are regulatory professionals with the knowledge and skills necessary to assess and regulate medicines effectively.

TOPRA was delighted to welcome six regulatory professionals involved in the transition from the African Medicine Regulatory Harmonisation (AMRH) programme to the establishment of the AMA who participated in an Autumn Introductory Course. These delegates were able to attend in person with the assistance of a grant covering travel and accommodation expenses from the Bill &Melinda Gates Foundation. The attendees actively participated in the course, asking questions, sharing their experiences and engaging with other delegates and speakers as well as with each other. As experienced regulatory professionals they were able to compare and contrast the EU systemwith the ones in their countries.

Participation in academic networks across the world TOPRA actively supports a wide number of global initiatives with an academic focus which helps to build networks and leverage a wide range of educational experiences across the world. We have a representative on the Board of the Association of Graduate Regulatory Educators (AGRE), which brings together

targeted at the needs of health regulators, the biomedical industry, pharmaceutical and medical device companies. It helps establish regional platforms and networks to build competencies, enhance collaboration and promote thought leadership in innovative regulatory science and policy. In China, TOPRA participated in the inaugural meeting of the Committee for International Pharmaceutical Regulatory Science Education Promotion. Attendees included representatives from universities across China, Korea, Taiwan, the US and Europe. As well as supporting universities and educators, TOPRA also has strong relationships with student-led organisations, eg, EPSA and Synapse – Life Science Connect. The European Pharmaceutical Students’ Association is an umbrella association of 45 Pharmaceutical Students’ Associations from 37 countries, representing over 100,000 pharmaceutical students across Europe. Based in Denmark, Synapse puts on events and networking for young professionals interested in life science careers. TOPRA has hosted an event for Synapse students at the London HQ.

leaders of international graduate training programmes in regulatory affairs and regulatory science. It promotes exchange of ideas among regulatory educators and supports research on competencies and development of the profession. TOPRA also has links with the Centre of Regulatory Excellence (CoRE), which is the first dedicated Asian Centre

TOPRA 2025 – Aspire | Adapt | Achieve 24