Mr. Asprec has over 20 years of pharmaceutical dossier assessment experience with the FDA Philippines, focusing on Drug Substance and Drug Product Quality, as well as In vivo and In vitro Equivalence Evidence evaluation. He was also previously assigned as a temporary adviser for Quality Assessment of the WHO Prequalification Team – Medicines.
Given the emphasis on regulatory convergence and reliance among national regulatory authorities (NRAs) in recent years, Mr. Asprec has served as the main focal point since the FDA Philippines’ early adoption of the WHO Collaborative Registration Procedure (CRP) of prequalified medicines as far back as 2016.
More recently, he assumed the rapporteur role when the FDA Philippines was the Lead NRA in the ASEAN Joint Assessment Procedure of 2 Cabotegravir formulations intended for pre-exposure prophylaxis (PrEP) against HIV/AIDS. This joint assessment endeavor was also participated by NRAs from Malaysia, Myanmar, Thailand and Vietnam.
He is currently actively involved in the implementation of the Facilitated Registration Pathways (FRPs) at the national level. Apart from his core function as a marketing authorization dossier assessor, Mr. Asprec counts the inspection of local bioavailability/bioequivalence (BA/BE) testing centers, and the ASEAN Harmonization for the Pharmaceutical Sector as his other areas of responsibility/expertise.
Mr. Asprec graduated with a Bachelor of Science in Pharmacy degree at the University of Santo Tomas in Manila in 2001. In the same year, he finished in the top 1% of the examinees who took the National Licensure Examinations for Pharmacists in the Philippines.
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