Thought leadership
To shape policy, practice and healthcare trends in the country, we inject professional and technical acumen into different engagement forums to drive an agenda for a proactive industry.
01.
Post Approval Changes (PAC) Workshop
The workshop organized inpartnership with MEDAK brought together pharmaceutical professionals and regulators to strengthen best practices in post-approval processes. The training was a capacity building initiative aimed at addressing the gaps causing delays in variation which affect the supply of medicines and HPTs in the country.
Key Outputs
- Changes in the PPB Variation Guidelines which include e.g official provision for annual notifications, immediate notifications minor variations – all with elements of automatic approval.
- Review of guidelines for submission of variation applications for registered biotherapeutic products.
02.
Reliance workshop
The Regulatory Reliance Workshop brought together key players from the pharmaceutical and medical device sectors, including KAPI, MEDAK, the Pharmacy and Poisons Board (PPB), the Pharmaceutical Society of Kenya, the Federation of Kenya Pharmaceutical Manufacturers, the Egyptian Drug Authority (EDA), and other regional and international experts. The purpose of this workshop was to review of the ‘Guidance on Reliance for Regulatory Decision Making in Kenya’, in January 2020 by PPB. A baseline survey conducted between November 2024 and January 2025 that aimed to gauge industry awareness and understanding of regulatory reliance, assess its practical use in submissions, and identify key enablers and challenges.
Key Outputs
- KAPI secured a follow-up meeting with PPB to address specific topics that may not have been fully covered during the workshop.
- Pharmacy and Poisons Board – announced a revised reliance guideline which was shared with stakeholders for comments until April 03, 2025.
03.
PV Learning Summit – Essentials of a Robust Pharmacovigilance System
The KAPI PVMA team, In shaping the understanding of a robust pharmacovigilance system, what it entails and shedding light on the role of a Qualified Person for Pharmacovigilance. The Learning summit brought together young pharmacists, young QPPVs, those already in the PV space and those who are looking to join the field.
Key Takeaways
- Need for more PV training sessions, including more informative, topic-specific, and future learning summits
- Need for more detailed information and practical sessions on preparing documents like PSURs and RMPs, as well as BCP and PSMF, including sample documents