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
- Modular e-Learning and webcast / Access possible at any time
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!
Save the date! Your regulatory update in pharmacovigilance with european drug safety experts and a special network event.
- Mannheim / 21. - 22.11.2019
Do you need essential European regulatory affairs knowledge? This course gives you a compact overview about all important issues. Each day may be booked separately according to your needs!
- Amsterdam / 25. - 27.11.2019
This workshop helps you collect, clean and structure all necessary data for IDMP and informs you on ePI (structured electronic product information) - a digitalisation project potentially utilizing IDMP and SPOR
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.
These six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.
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...).
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
