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Training - ISoP Mid Year Training Course

ISoP Mid-Year
Training Course

Nairobi, Kenya
6-8 May 2019

Pharmacovigilance in Africa beyond spontaneous reports


ISoP/ASoP Mid-Year Symposium and Training course – Nairobi

Coordinators: Hilda Ampadu (ISoP Board member) and Jean-Christophe Delumeau (ISoP Executive member)

This Symposium and Training event, the first of this kind organised in Africa, was addressing 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.

Despite efforts for improving the spontaneous reporting of adverse events in Africa, the reporting behaviour remains sub-optimal to the extent of urging to develop new approaches for collecting safety data e.g. by involving consumers and patients directly. On the other hand, risk minimisation methods that suit African health care systems need to be developed and implemented. In such a context, and moreover in the perspective of the upcoming constitution of the African Medicinal Agency, this mid-year Symposium & Training Course was aimed to be a milestone for sharing ideas on how to improve the different components of safety regulatory systems and practices.

This ISoP/ASoP Symposium & Training Course was intended for an audience including representatives from National Regulatory Authorities, Universities, Hospitals and industry professionals. At the term of this event the participants are expected to have an overall understanding of pharmacovigilance systems, practices and issues in Africa and beyond, and be capable of promoting practices according to international standards.

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

The programme included the following topics:
• Current Pharmacovigilance Landscape in Africa
The evolution of Pharmacovigilance in Africa. The key drivers of change in African Communities. Perspectives.
• Pharmacovigilance during the pre-approval phase in Africa
Safety regulatory systems applicable in Africa to the clinical development of medicines for African needs.
• Pragmatic Active Methodology applicable to PV in Africa
Pharmaco-epidemiological methods and other methods designed to fit with Africa’s unique challenges. Implications beyond Africa potentially resulting from the use of those methods.
• Strengthening of Pharmacovigilance regulations in Africa
Implementing the concept of Qualified Person in Pharmacovigilance (QPPV). African Medicines Regulatory Harmonisation Programme, EAC Initiatives, PV inspections, PV System Master File (PSMF).
• Risk Management Planning
Benefit versus Risk evaluation methods, Risk Management planning, Risk minimisation methods. Safety communication methods in African contexts. Applying those methods in African health care systems.

Lectures, working groups and panel discussions were the main training method, with ample opportunity to exchange views and ideas in discussions following individual presentations, after the panel discussion at the end of the seminar and during coffee breaks.
Training certificates were provided by e-mail to those who complete the course.

The feedback gathered from the attendees at the seminar was very positive.

Read more: Report of the event written by one of the delegates, Ryan Walker from Global Pharmacovigilance, an open-access PV forum, The Global Health Network.

Participants in Nairobi



Meeting Venue


Idyllically located 5 minutes’ drive from the CBD, set in spacious natural gardens and 18 km from Jomo Kenyatta International Airport, Sarova Panafric Nairobi offers 162 rooms in a range of Superior, Executive, Club, Studio and Suites. It features 2 restaurants, a bar and a swimming pool and offers wide range of facilities for meetings, conferences, banquets (wifi available).
For more information please visit the hotel’s website

Along Valley Road,
Tel: +254 709 111 000


You may book your room at Sarova Panafric Hotel (Hotel venue). Rooms subject to availability.
All rooms have the following amenities: fully air-conditioned, safe deposit box, wireless internet, private bath with shower, WC and hair dryer (voltage of 240 volts, separate razor outlets), direct dial telephone with voice mail. Satellite TV with remote control, mini bar and tea/coffee making facilities.

Check-in time: 2 pm
Check-out time: 11 am

Nairobi, Kenya

Beautiful landscapes, savannahs, wildlife, traditional peoples, successful conservation communities. Welcome to Kenya!
Kenya Tourist Board (KTB)-

Nairobi, one of Africa’s largest and most interesting cities, is the safari capital of Africa and a good base for travel in Kenya. The city has many attractions which include Nairobi National Park, and the National Museum.
The average temperature in May is 19ºC, with highs of 24ºC.


If nationals from some African countries may enter the Republic of Kenya without a visa, most foreign nationals will need a visa.
Visas and entry conditions in Kenya, click here.
You can get your visa directly at the airport (fee 51 US$) but to save time and anxiety at arrival it is better to have the visa in advance.
The procedure of online application has now been modified and simplified to a user friendly mode that takes three simple steps. The E-Visa portal has its dedicated website:

More information about Visa application requirements, click here.
Website of the Kenyan High Commission (UK)

Invitation letter / visa

Please contact if you require an invitation letter for visa purposes. Please note this service does not imply any financial support and it is not an official invitation covering fees or/and other expenses.

Medical requirements to enter Kenya
Please check vaccine recommendations here

Need more information?

If you would like more details about this course please contact ISoP Administration