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Cecil Nick


Cecil Nick

PAREXEL International, UK

Biography

Cecil Nick holds BSc (Hons) in Biochemistry from the University of Cape Town, South Africa. He has been the Regulatory Affairs Professional for over 30 years. He has expertise in monoclonal and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported 6 submissions in the EU and US. He has also participated extensively in industry and international meetings on the subject. Prior to joining Parexel, he served as Regulatory Manager at Novo Nordisk Ltd, Fellow of TOPRA and has been a Guest Lecturer at Cardiff University for MSc in Clinical Research and Greenwich University for MSc in Pharmaceutical Sciences courses and Biotech Module Leader for the TOPRA MSc course. He was on the Editorial Panel of Scrip Clinical Research and has authored many articles on Regulatory and Clinical Development Issues.

Abstract

Abstract : Optimizing clinical trials as part of the totality of data to support the marketing approval of biosimilars