Hilde Bastaerts, PharmD

Pharmaceutical Quality Specialist at European Medicines Agency

Speaker

Hilde holds a M.Sc. in Pharmaceutical Sciences from Ghent University, and a certificate in Industrial Pharmacy (EU qualified person).

She has >25 years of experience in pharmaceutical industry, in various functions in quality assurance/quality control, as well as CMC development and CMC regulatory affairs. In 2021 she joined the European Medicines Agency, where she works in the Pharmaceutical Quality Office as a senior pharmaceutical quality specialist. In her current role she supports procedures for initial marketing authorisations (centralised procedures), scientific advices, and postapproval variations, interacting with QWP, BWP and CHMP. She is a member of the drafting group working on the synthetic peptide and oligonucleotide guidelines.