Kurs derzeit nicht verfügbar
Pharmacovigilance Requirements in Emerging Markets - This course focuses on China - LATAM - Russia - MENA
Seminar
In Frankfurt ()
Beschreibung
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Kursart
Seminar
-
Dauer
2 Tage
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.
Hinweise zu diesem Kurs
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.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Management
- China
- Risk Management
Inhalte
Pharmacovigilance Requirements in Emerging Markets - This course focuses on China - LATAM - Russia - MENA