This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.
This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.
Figen Kabdas is a Senior Regulatory Affairs Consultant & Trainer with over 13 year's experience in Regulatory Affairs for generics, vaccines and biosimilars with specific expertise in the EU & US markets including Turkey, the Middle East and Asia Pacific. Since 2012, Figen has been delivering expert training to the Pharmaceutical industry and has been a guest speaker at International Regulatory Affairs conferences.
This course is relevant for anyone working within the field of regulatory affairs at management level or above, such as:
I enjoyed learning through the case studies. The course content was excellent.
The interaction and questions asked from fellow participants was useful.
Discussing with other students local ways of working was really helpful.