Understanding European Filing and Registration Procedures for Drug Approval 2016 is a webinar that covers topics such as:
- Steps required prior to submission of a marketing authorization application (MAA)
- How to choose the appropriate pathway to drug approval in the EU
- Expectations of the sponsor during the review process
- Key timelines before, during, and after submission of an MAA
- Life cycle management of the MAA
- Follow up on applications after approval
Understanding European Filing and Registration Procedures for Drug Approval 2016 is intended for:
- Employees involved in any area providing information for a MAA
- Vice Presidents, Directors, & Managers of regulatory, clinical and manufacturing areas
- All companies developing drugs or biologics for approval in the EU
- All Regulatory affairs personnel working on EU submissions
