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 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 experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies.
Our course will provide insights into the current pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training.
Payment of high-priced drugs in the UK, BeNeLuxAI, Italy and Germany - this is where you'll get to know current and upcoming pricing models.
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
