This course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
- Amsterdam / 25. - 26.09.2019
eSubmission in Saudi Arabia, the GCC, Oman, the UAE, Bahrain and Jordan. Learn about what is required for the submission portal.
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.
After having attended this course you know how to enter the Middle Eastern, European and Russian markets with your herbal product, food supplement, generics or borderline product
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.
Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
Basic and advanced know-how on the current regulatory framework of the various countries will be addressed in this course.
- Mannheim / 22. - 24.10.2019
THE course for pharmacovigilance managers!
- Amsterdam / 29. - 30.10.2019
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!