Sjeng Hovens Email & Phone Number

Pharmaceutical advisor to human and veterinary pharmaceutical companies inside and outside the EUActivities: - Composition of dossiers for marketing authorisation and expert reports for human and veterinary medicinal products- Management of national and international marketing authorisation procedures, including complete management of CP/DCP/MRP procedures- Assessment of marketing authorisation dossiers- Consultancy on marketing authorisation strategy - Consultancy on business development / licencing- Product development of generic pharmaceutical products, which includes the complete management starting with identification of the active ingredient source upto registration in the EU via DCP/MRP/CP.- Assessment and composition of European Drug Master Files- EDMF certification of suitability of EP monograph- Scientific Advice meetings

Nijmegen Area, Netherlands

- Marketing authorization service- EU batch release service- GMP/GDP auditing service

DUMEX BV, Hilversum (NL) [Later Alpharma BV and nowadays Actavis B.V., Baarn, (NL)]Manager pharmaceutical affairs / responsible pharmacist.Regulatory affairs, QA/QC, product development, pharmaceutical/medical information:- management of > 100 marketing authorisation applications.- set up and maintenance of QA/QC system for > 200 products.- auditing of toll-manufacturers, packagers, label and leaflet suppliers- monitoring of product development- pharmaceutical/medical information internal and external to medical and pharmaceutical professionals.