About us

We are The Pharmacovigilance (PV) Academy

Whilst the PV and Drug Safety landscape in Africa is in development and countries are fast becoming aware of the need for robust legislation on PV, real challenges still exist across Africa with respect to reporting of adverse events and risk minimization measures.

The emergence of the African Medicines Agency (AMA) as the Agency that provides regulatory leadership, promises to bring harmony, regulatory governance and will act as the gold standard for PV in Africa.

In this developing/growing environment, The PV Academy serves to enhance awareness, forward- thinking and confidence to PV personnel across Africa using training and workshops that strengthen their experience and equip them with the necessary tools to perform at their optimum within Industry, Regulatory bodies, and Healthcare professionals.

In this new African era, these training events are the first of this kind organized in Africa, for PV professionals who work within the pharmaceutical industry.

The PV Academy organises webinars, seminars, and workshops across the African continent. Our team of PV experts as well as our esteemed speakers remain continuously at hand to support delegates during and after these events.

Each level of training will have its own dedicated agenda and topics which take the participant on a fulfilling journey through the different skills required in PV practice.

• Understand the international history, the principles and regulatory framework for pre- and post-approval clinical safety and PV
• Understand the African national, regional, and continental regulatory framework for pre- and post-approval clinical safety and PV
• Recognize the need for safety surveillance and understand its significance in daily work
• Understand the basic definitions of terms, scope of work, and purpose of PV
• Understand the key PV activities
• Demonstrate an awareness of PV planning, risk management/risk minimization methods and benefice-risk assessment
• To acquire the skills for producing well written case narratives and the proper medical, causality and seriousness assessment of Individual Case Safety Reports (ICSRs) for reporting to regulatory authorities.
• To develop a critical understanding of the types, assessment and appropriate application of post-marketing drug safety data and their contribution to the safety monitoring and risk management of medicines.
• To develop knowledge and understanding of the principle of risk benefit assessment.
• To gain knowledge on the conduct of signal detection and analysis methods to critically analyse the available data and to ensure that safety signals are appropriately managed and tracked.
• To be able to identify potential signals and validate those signals as appropriate.
• To be able, based on the principles of safety data assessment and signal detection, to integrate the appropriate strategies within risk management plans and to be able to transcribe the finding into national, regional or continental safety decision related to medicines.
• To gain practical experience and knowledge in the planning, writing and reviewing of periodic reports, the gathering and assessment of data, the benefit-risk assessments, and the submission to regulatory authorities.