Seminare zu Regulatory Affairs
Regulatory Affairs

Veranstaltungen FÜR "Regulatory Affairs"

ERGEBNISSE SORTIEREN

Webcast Series: Legal Issues in Regulatory Affairs

These recorded six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.

  • Online /

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...).

  • Online /

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

  • Online /
  • Online / 31.12.2019

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.

  • Online /

eCTD preparation and submission

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.

  • Online /
  • Online / 31.12.2019

e-Learning: CTD Module 3

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.

  • Online /
  • Online / 31.12.2019
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