1. Introduction
The Qualified Person for Pharmacovigilance (QPPV) Learning Summit was convened by the KAPI – Industry Alliance of Health Products and Technologies Pharmacovigilance and Medical Affairs Committee Working Group to strengthen pharmacovigilance capacity in Kenya. The summit aimed to foster best practice sharing, regulatory understanding, and professional networking among Pharmacovigilance professionals.
PPB has been providing formal QPPV training every 2 years on a rolling basis. Keeping in mind that most KAPI members remain compliant to this need for a formal QPPV nominated, there remains a gap especially at local manufacturing company level. Additionally, there has been demand from students who aspire to a career in PV to KAPI PVMA committee members to provide a mentorship program to understand PV and the role of QPPVs in depth.
Due to the demand for mentorship, KAPI undertook this opportunity and co-funded (50-50% approach) the learning summit.
2. Planning and Coordination
Planning involved weekly meetings to refine the agenda and logistics. The working group consisted of 9 members, who worked on the training materials. Review and drafting of the agenda was done collaboratively. Pharmacy and Poisons Board Pharmacovigilance Department was invited but could not attend due to a concurrent audit. They, however, gave us a go-ahead to proceed with the planned activity.
3. Summit Highlights
Presentations focused on the individual components of a PV system (QPPV, PSMF/PSSF, BCP, Audits, GDocP, QMS, PV Agreements, Regulatory Intelligence and Clinical Trials) and how to set such a system up, regulatory oversight, adverse event reporting, and stakeholder engagement.
The event fostered active engagement and knowledge exchange among industry and regulatory professionals.
4. Participant Feedback Summary
4.1 General Overview
4.2 Suggestions & Requests
– Strong demand for hands-on training on preparing documents like PSUR, PSMF, and RMP, especially for those handling PV for local manufacturers who may not have prior access to these documents.
– Proposal to break down topics into multiple sessions or a multi-day format.
– Use of visual aids and sample documents (e.g., ICSR forms).
– Desire for more inclusive events and networking platforms.
– Suggested breakout sessions to enhance interaction and group discussions.
– Request for lighter moments and jokes to improve engagement.
– Interest in regular monthly catch-up sessions.
– Request to share relevant job openings during or after training.
Request for more training/sessions: Many respondents requested more PV learning summits, future training courses, or a series of training sessions, suggesting an increase in the number of days (2 or 3 days) or scheduling more frequent sessions (monthly meetings, topic-specific days).
Practical/Detailed content: Several attendees requested more practical sessions and detailed information, specifically on preparing documents like PSURs, RMPs, BCP, and PSMF, and using training aids such as ICSR report forms, PQHPTS reporting forms, and sample documents.
Provision of certificates and materials: There were multiple requests to offer a certificate for the training and to kindly share the training materials/slides for reference.
Collaboration with PPB to have more accredited training for new and continuing QPPVs.
Positive feedback on execution and speakers: Respondents widely praised the event as well-organized, executed, informative, and educative. Presenters were commended for being well-equipped, insightful, well-articulated, and explaining complex subjects simply.
Other suggestions: Other suggestions included increasing test questions and case studies, having a breakout session, providing insights on resources for beginners, and sharing job opportunities. The venue (Tamarind) was noted as slightly far out but good.
4.3 Appreciations
– Presenters were praised for being well-equipped and articulate.
– The summit was described as informative, inspiring, and well-executed.
– Special thanks to Loice for her dedication and coordination efforts.
5. Outcomes and Next Steps
– The summit achieved its objectives of knowledge sharing and capacity building.
– Enhanced understanding of PV systems and strengthened collaboration between industry and regulators.
– Clear demand for more practical, hands-on, and frequent training sessions.
– Plans to extend future summits and explore accredited training partnerships.
Prepared by: Angelica Gende (Patient Safety Specialist, KAPI QPPV Learning Summit Chairperson) & Laila Kasumba (RA/PV Pharmacist, KAPI PVMA Secretary)