The safety and risk management of medicinal products has undergone a period of extensive change, with regulations in developed regions becoming more stringent and in other regions, regulations are evolving rapidly with high expectations.
These increasingly stringent and rapidly evolving regulations have led to the internationalization of Good Vigilance Practices, i.e. the adoption of GVP by several countries in the META region.

• Review national regional PV legislation.
• Link global QPPV role to local, and regional QPPV per requirements
• Assess the current level of company compliance per country, and region as well as alignment with deviation from the EU requirements META, LATAM, APAC, EAEU and CIS
• Develop a framework to ensure future compliance covering.
•Training
•PSSF development and production
•Documentation e.g. delegations of Local Regional SOPs
• Compliance metrics and oversight are particularly important
• Communication and information flow internally and externally

Ashraf Megahed

Regional QPPV (Qualified Person for Pharmacovigilance) & Quality Manager META

CSL Vifor