Cecil Nick
PAREXEL International, UK
Biography
Regulatory affairs professional for over 30 years. Has particular expertise in monoclonals 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, Cecil served as Regulatory Manager at Novo Nordisk Ltd. Fellow of TOPRA and has been a guest lecture at Cardiff University MSc in Clinical Research and Greenwich University 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. Holds BSc (Hons) in Biochemistry from the University of Cape Town.
Abstract
Abstract : Meeting the challenges of gaining marketing approval of biosimilars across the globe