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 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.
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!
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.
This online course will show you how to write scientific documents such as a clinical evaluation in good and readable English that is appropriate to your audience, while complying with the regulatory requirements.
- online / 13. - 14.05.2020
How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our online-seminar via Zoom!
This online conference - ExpertFORUM Labelling - discusses essential trends in product information, including digitalisation, patient accessibility to safety labelling and IDMP requirements.
- online / 18. - 19.05.2020
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.
- online / 18. - 19.05.2020
This online biosimilars seminar addresses the available options for market access in the US and EU, including negotiating with the originator.
