Jakob Bonde

Managed, tracked, compiled, and submitted European CTA, ODA/ODD, PIP’s for medicinal products Provided regulatory advice and guidance to Clinical Operations, Medical Writing, Data Management, GMP auditing and sponsors to ensure compliance with SOPs, European guidance and regulations Participation in KOM, BID and EMA Scientific Advice for ODD and PIP. Performed gap analysis and strategic advice of quality, import/export and technical writing for IMPD’s for NCE’s, Biologics and ATMP’s.