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!
This 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.
- München / 18. - 19.09.2019
A course to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.
- Frankfurt-Raunheim / 23. - 24.09.2019
This course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
- Amsterdam / 25. - 26.09.2019
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.
Effective oversight of outsourced activities in the healthcare sector - Prepare yourself for the balancing act between compliance and outsourcing, and learn how to implement your own effective regulatory vendor oversight programme.
- Berlin / 08. - 09.10.2019
How to write the Module 3 for Regulatory Submission - Here you will get in-depth information.
