Pharmacovigilance Requirements in Emerging Markets - This course focuses on China - LATAM - Russia - MENA

Regulatory expectations around risk management for medicinal products in emerging markets are competing with the stringent standards set by the EU/ICH regions. The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix.
Our experts will give you a detailed update on the current legal and regulatory background and on your duties with regard to:
- ADR collection and reporting;
- PSUR requirements;
- Risk management plans (RMPs); and PSMF in selected emerging countries.
Moreover, our seminar will help you create a structure to integrate your local PV system into a global system.