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

- Legal framework in selected emerging countries
- Similarities and differences compared to EMA regarding ADR collection and reporting
- PSMF, PSURs and RMPs - country-specific requirements
- How to integrate local PV systems into a global system
- Cooperating successfully with the 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.

Termin

Datum: 24.06.2019
Ort: Steigenberger Airport Hotel
Unterschweinstiege 16
-60549 Frankfurt
Preis: 1.790,00 EUR zzgl. MwSt.
 

Zielgruppe

This seminar addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those dealing with international pharmacovigilance issues, such as:

- drug safety managers;
- clinical trials managers; and
- regulatory affairs managers.

Good knowledge of the European pharmacovigilance framework is a prerequisite.

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Zerfallszeittester / Disintegration Tester DISI