The final workshop of the CT Luso training course, dedicated to the theme "International Regulatory Systems", took place on June 3rd and marked the conclusion of Module 6 – Regulatory Affairs, as well as the end of the training course "Ethical and Legal Principles for the Development of Scientific and Clinical Research", which began on December 3rd, 2024.
The online meeting was moderated by two PhDs in Pharmacy: Bruno Sepodes (Portugal), who addressed the European Regulatory System, and Djamila Gomes (Cape Verde), who presented an overview of the African Regulatory System, which is still under construction and consolidation.
The session was also attended and participated in by African guests from various drug regulatory agencies and institutions:Pombal Mayembe, Head of the Regulatory Agency for Medicines and Medical Equipment - ARMED (Angola)Eduardo Tavares, President of the Independent Health Regulatory Authority - ERIS (Cape Verde)
Carlos da Costa, President of the Installation Commission of the National Regulatory Authority for Pharmacies and Medicines - ARFAME (Guinea-Bissau)Tânia Sitoie, President of the National Regulatory Authority for Medicines - ANARME (Mozambique)Hironisia dos Santos, Head of the Pharmaceutical Department of the Ministry of Health (São Tomé and Príncipe)
Challenges and paths for the futureThe debate focused on five key issues shaping the future of medicine regulation on the African continent, with emphasis on:The impact of the creation of the African Medicines Agency (AMA) in the current context of the Harmonisation Initiative (AMRH);The need to ensure the transposition of AMA recommendations at national level;
The definition of criteria for prioritising products at national, regional or continental level;Strategies to avoid duplication of efforts in the evaluation, approval and surveillance of products;The management of existing scarce technical capacity, given the need to act at different levels.
Workshop participants highlighted the progress made in their countries, the challenges they still face and the importance of AMA for greater efficiency, safety and regulatory coordination on the African continent.Six months of learning and cooperationThis initiative concludes a six-month training course consisting of six modules. A total of 213 trainees took the final test, and those who did not pass will still have the opportunity to submit a paper to recover their grade. With an eye on the future and to ensure the continued sharing of knowledge, the next step is to gather feedback from all trainees to identify the most relevant topics for webinars aligned with the real interests and challenges of each country.
CT Luso thus concludes another stage, with the ambition of continuing to train professionals from Portuguese-speaking countries for the challenges of regulation, research and clinical trials.
