Seminare zu Regulatory affairs & vigilance
Regulatory affairs & vigilance
Regulatory training programmes and courses
you should not miss.

Results FOR "Regulatory affairs & vigilance"

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Global Regulatory Affairs Manager

This online training addresses the needs of regulatory affairs managers dealing with marketing authorisations outside the EU or planning to do so in the future.

  • Modular e-Learning and webcast / Access possible at any time

Development Expert Biologics

  • Modular e-Learning and webcast / Access possible at any time

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 / 31.12.2020

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 /

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 /

e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological pharmaceutical products in the ICH region.

  • Online /

Medical Devices in the Middle East & North Africa (MENA)

Marketing authorisation of medical devices in the GCC states like Saudi Arabia and the United Arabian Emirates, Egypt, Algeria, Morocco, Tunisia and Iran. This course gives you practical advice. Please take a look at the brochure.

  • Frankfurt-Raunheim / 12.02.2020

The Pharmacovigilance System Master File (PSMF) in a Global Environment

This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.

  • Frankfurt / 13.02.2020

Scientific Writing and Reviewing in Regulatory Affairs

After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.

  • Frankfurt / 17. - 18.02.2020
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