Veranstaltungen FÜR "Regulatory Affairs"

Fachreferent/Fachreferentin Arzneimittelzulassung

Das FORUM Institut für Management möchte Sie in Ihrer Fort- und Weiterbildung nachhaltig unterstützen. Aus diesem Grund bieten wir Ihnen im pharmazeutischen Bereich neben unseren tradierten Intensivseminaren und Konferenzen nun auch drei modulare Ausbildungslehrgänge an, um Ihr Wissen in den einzelnen Fachbereichen auszubauen und zu vertiefen.

PharmaFORUM Webcast International "eCTD worldwide"

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!

PharmaFORUM Webcast Biologics "Interaction with Agencies"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

PharmaFORUM Webcast Biologics "QbD elements in early and late stage biotherapeutic development (from research to first in human until commercial)"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

PharmaFORUM Webcast International "Pharmaceutical Documentation and CMC Strategy"

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!

PharmaFORUM Webcast Biologics "Quality of Biotech-IMPs - the current challenges"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).

e-Learning: Common Technical Document & eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.

e-Learning: EU-Variations erstellen und einreichen

Dieses e-Learning hilft Ihnen, Änderungstatbestände korrekt zu klassifizieren und als Variations mittels eAF einzureichen.

e-Learning: Marketing Authorisation Outside the ICH Region

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed