CRED Getting the CMC Dossier Right 2024

Speaker Biographies Vimal Patel Vimal started his career in 1981 with Glaxo in pharmaceutical research and development working on various dosage forms and taking these from“bench to production”. In 1997, Vimal moved over to regulatory working on CMC changes on established products. Vimal then took on the project management of the regulatory activities for site rationalisation projects with subsequent transfer of products to alternative sources. In 2005 Vimal joined Pharmalink Consulting Ltd and worked on various regulatory projects with several large pharmaceutical companies whilst managing a large team of regulatory consultants. In 2010 Vimal joined Reckitt Benckiser to head up a global compliance project working on over 5000 SKUs supplied to over 100 markets resulting in filings of over 2000 variations worldwide in order to bring product documentation and manufacturing practices back into compliance. In 2016 Vimal worked independently for GSK and Theramex on a consultancy basis on established products in the CMC area. Vimal is a Fellow member of TOPRA and a lead volunteer for one of the CMC CRED areas. Vimal was also a member of the Life-Long Learning Committee which was formed by TOPRA to address and capture the training and continuous development of regulatory professionals. Vimal is also a volunteer with St Johns Ambulance and helped to vaccinate in local pharmacies and mass vaccination centres during the Covid pandemic. Sargon Daniel Sargon has gained over 25 years of Regulatory Affairs experience in the industry and CROs, working for both several Bio-Pharmaceutical companies and CROs. Nowadays Sargon mainly focuses on Phase 1 to Phase 3 strategic development of medicines for infectious disease. He currently works at Vir Biotechnology. Chris Carr Chris is a highly experienced regulatory affairs professional with almost 20 years in the industry, working as a regulator; in the pharmaceutical industry across multiple regulatory areas from product development through to post marketing; consulting and most recently held the post of head of regulatory affairs for the Cell and Gene Therapy Catapult.