virtual 2 Veranstaltungen

PREFERRED

CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe

FORUM Institut für Management GmbH (147)

- Regulatory requirements in the EU and the ICH region - Essential quality data for marketing authorisation - CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary - Management of post-approval changes - Classification of quality related...

• Webinar
• Ohne Einstufung

• 12.11.2024 - 13.11.2024

PREFERRED

Variations in Europe - Your regulatory and procedural online guidance

FORUM Institut für Management GmbH (147)

- Classification and submission - Type IA Notification, Type IB and II Variations - Grouping and worksharing - Variation management - Quality-related variations: Changes in the production process, analytics, formulation and packaging LAST CALL! - CAN...

• Webinar
• Ohne Einstufung

• 15.05.2024 - 16.05.2024