Training - ISoP Mid Year Training Course

ISoP Mid-Year
Training Course

Nairobi, Kenya
6-8 May 2019


Pharmacovigilance in Africa beyond spontaneous reports

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ISoP-Mid-Year-Nairobi-2019

Mid-Year Symposium and Training course – Nairobi (Kenya)

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, will be 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 is aimed to be a milestone for sharing ideas on how to improve the different components of safety regulatory systems and practices.

This ISoP Symposium & Training Course is 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 will include 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 will be the main training method. There will be 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 will be provided to those who complete the course.


Programme

 


Meeting Venue

SAROVA PANAFRIC NAIROBI HOTEL

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 https://www.sarovahotels.com/panafric-nairobi/

SAROVA PANAFRIC HOTEL
Along Valley Road,
Nairobi
Tel: +254 709 111 000

Accommodation

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
Please contact directly Kevin.nganga@sarovahotels.com for reservation at the hotel meeting venue. Rates starting at US$ 120 inclusive tax and breakfast) per night.

Nairobi, Kenya

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

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.

Visas

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: www.evisa.go.ke.

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

Invitation letter / visa

Please contact administration@isoponline.org 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

Registration

Already a Member of ISoP?

Current members of ISoP are eligible for a “member” rate. Please choose the appropriate option below when logged in to your account.

Full Registration

High Income Countries*

(Conditions apply – see below)

€550.00 + 12 Euros Card fee.
REGISTER NOW

Full Registration

African Countries

(Private Sector e.g. Pharma, CRO, Private Hospitals)

€400.00 + 12 Euros Card fee.
REGISTER NOW

Full Registration

African Countries

(Public Sector e.g. Academia, Authority, Public/Military Hospitals)

€250.00 + 12 Euros Card fee.
REGISTER NOW

Not a Member of ISoP?

Non member registrations for our Nairobi Mid-Year Symposium and Training course include complimentary ISoP Membership.
Please choose the appropriate option below to pay online with your credit card.

If you have any questions or wish to pay via Bank Transfer please contact ISoP Administration

Fees include lunch with drinks and coffee breaks but do not include accommodation, dinner or travel.

Full Registration

High Income Countries*

(Conditions apply – see below)
 

€650.00 + 12 Euros Card fee.

(Includes complimentary ISoP Membership)
REGISTER NOW

Full Registration

African Countries

(Private Sector e.g. Pharma, CRO, Private Hospitals)

€500.00 + 12 Euros Card fee.

(Includes complimentary ISoP Membership)
REGISTER NOW

Full Registration

African Countries

(Public Sector e.g. Academia, Authority, Public/Military Hospitals)

€350.00 + 12 Euros Card fee.

(Includes complimentary ISoP Membership)
REGISTER NOW

(*)High Income Countries include:
Hong Kong, Taiwan, Macao, Singapore, Brunei, Korea, Japan, Australia, New Zealand, Canada, USA, Israel, EU/AELE, Bahrain, Qatar, Saudi Arabia, Kuwait, Oman, UAE