Training - ISoP Mid Year Training Course

ISoP Mid-Year
Training Course

Nairobi, Kenya
6-8 May 2019

Pharmacovigilance in Africa beyond spontaneous reports


Mid-Year Training course – Nairobi (Kenya)

Coordinator: Hilda Ampadu

This training course will address the specific needs and interests of people working in the field of pharmacovigilance either in regulatory agencies, pharmaceutical companies, in academia, hospitals or community settings.

Pharmacovigilance in Africa has solely focused on spontaneous reporting. Due to the fact that reports are still low in Africa, there is a need to embark improving methodologies for collecting data.
This mid-year training has therefore been proposed by ISoP to deliver theory and experiential learning of pharmacovigilance, including but not limited to regulatory systems in Africa, methodologies based on Africa’s unique challenges, QPPV requirements and needs for PV inspection.

Target audiences include regulatory agencies, universities, researchers in clinical trials, hospitals and industry professionals.

At the end of the course, the participants are expected to have an overall understanding of the current pharmacovigilance in Africa and good pharmacovigilance practice to promote product safety.

The faculty for this course consists of international and national experts in pharmacovigilance, representing government, academia, and industry.

The programme will include the following topics:
• Current PV Landscape
The evolution of Pharmacovigilance in Africa, Key drivers of change in Pharmacovigilance in the East African Community (EAC)
• Pharmacovigilance in Pre-market regulation
Regulatory systems in Africa, New drug discovery, Clinical trials
• Pragmatic Active Methodology in Africa
Methods based around Africa’s unique challenges,
Methods used in industry, International implication for method selection
• Emerging Pharmacovigilance regulations in Africa
QPPV role, African Medicines Regulatory Harmonisation Programme & EAC Initiatives,
PV inspection, Pharmacovigilance system master file (PSMF)

This course is organized in the capital city of Nairobi, Kenya. It is the first time that such ISoP training has been undertaken in Africa.

More information about preliminary agenda, registration and venue available soon. Register your interest at