Pharmacovigilance Requirements in China - LATAM - EAEU - MENA - 5 webcasts in two days: Legal framework, Country-specific requirements and more - Webinar von FORUM Institut für Management GmbH

- Legal framework in selected (emerging) countries or regions - Similarities and differences in ADR collection and reporting compared to EMA standards - Country-specific requirements for PSMF, PSURs and RMPs - How to integrate local PV systems into a global system - Special focus on China, LATAM, EAEU and MENARegulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!

International pharmaceutical manufacturers, depending on the region, face different regulatory requirements. In the field of pharmacovigilance, risk management for pharmaceuticals in emerging markets often competes with the stringent standards set in the EU/ICH regions. The diverse and relevant regulations of individual countries or regions require a finely tuned balance, ensuring that all local pharmacovigilance systems used by a company are integrated into a unified and truly global pharmacovigilance matrix.- Our experts provide you with a comprehensive update on the current legal and regulatory landscape, with a focus on your responsibilities related to the following: - Collection and reporting of Adverse Drug Reactions (ADRs) - Periodic Safety Update Report (PSUR) requirements - Requirements for the Risk Management Plan (RMP) - Global and local Pharmacovigilance System Master File (PSMF)

This course will be conducted in English.- This seminar caters to individuals in the pharmaceutical industry, particularly those dealing with international pharmacovigilance issues, such as: - Qualified Persons for Pharmacovigilance (QPPVs) - drug safety managers - clinical trials managers - regulatory affairs managersGood knowledge of the European pharmacovigilance framework is prerequisite for participation.