Pharmacovigilance Requirements in Emerging Markets

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.