The Food and Drugs Authority has provided technical support to the Netherlands Pharmacovigilance Centre (LAREB) to provide Qualified Persons for Pharmacovigilance (QPPV) training.
The training is for regulators from the National Medicine Regulatory Authorities (NMRAs) of four African countries namely; Ethiopian Food and Drugs Authority, Pharmacy and Poisons Board (Kenya), Rwanda Food and Drugs Authority, and Tanzania Medicines and Medical Devices Authority under the PROFORMA Project
The six-day virtual training under the theme “Teach the Teacher for QPPV” had the goal to equip the regulators with the knowledge to be able to develop country-specific QPPV training and implementation plans tailored to address country-related pharmacovigilance challenges.
The training was attended by over 45 participants with staff from the NMRAs as well as participants from some Medical Universities such as Addis Ababa University (Ethiopia), Muhimbili University of Health and Allied Sciences (Tanzania), University of Nairobi (Kenya), and the University of Rwanda.
FDA facilitated a session on the underlisted:
- Roles and responsibilities of QPPVs,
- Purpose and evaluation of regulatory documents including Periodic Safety Update of Reports (PSUR/PBRER) and Risk Management Plans (RMPs)
- Principles of benefits and risks evaluation in the review of these documents.
- Pharmacovigilance inspections and audits
In addition to the formal presentations, the FDA was able to share its experience in the implementation of legal pharmacovigilance requirements for marketing authorization holders.
The FDA implemented the QPPV concept in 2015 and has since trained 172 QPPV and conducted over 71 Good Pharmacovigilance Practice Inspection.
The FDA is a Regional Centre of Regulatory Excellence (RCORE) for pharmacovigilance and in 2021, the FDA’s vigilance function was assessed as Maturity level 4 based on the WHO Global Benchmarking Tool.
This is the highest level of the ranking system.
The FDA looks forward to continuously contributing to the development and strengthening of pharmacovigilance activities in Africa and globally to ensure patient safety.
Latest Stories
- If you want Olympic boxing medals in Paris move the Black Bombers to camp now!
13 mins - NSMQ 2023: 34 schools battle it out for Regional Qualifiers in Western Region
14 mins - RTI Commission fines Police Service ¢100k for flouting directives
29 mins - Attorney General reviewing draft contract between Tema Oil Refinery, private investor – Deputy Minister of Energy
43 mins - Assin North By-election: Who has the edge – An analysis
45 mins - World Bank supports Ghana to expand, enhance social safety nets, including for 3.6 million school children
50 mins - We won’t withhold our approval of Chief Justice nominee – Minority backs Gertrude Torkornoo
50 mins - Kumawu roads construction: Residents unhappy with pace and quality of work
1 hour - Take or pay contracts must be reviewed – Energy expert
1 hour - Kwahu Nkwatia chief convicted for contempt, court orders his removal from palace
1 hour - Empress Gifty explains why she now sings in English
1 hour - AshGold – Allies match-fixing: We believe GFA didn’t have enough evidence to ban players – Chibsah
1 hour - Government must develop programmes to alleviate plight of ‘kayayei’ – CHRAJ
2 hours - Anthrax outbreak: One-month ban placed on movement of ruminants in Upper East Region
2 hours - Microsoft to pay $20m for child privacy violations
2 hours