CRED Getting the CMC Dossier Right 2024

addition, he has participated in several cross-divisional/ cross-functional project teams and DRA-coordination groups in Sandoz. From 2009 until 2015, Christian spent much time for the TOPRA Master in Regulatory Affairs. In 2022, Christian left the generics world and joined Eckert & Ziegler Radiopharma GmbH as Regulatory Affairs Manager for established and new radiopharmaceutical precursor products Sharon Page Sharon Page has more than 25 years of experience in the pharmaceutical industry covering drug product development and regulatory sciences. She is based in the United Kingdom and has global responsibilities for Chemistry, Manufacturing and Control (CMC), from IND/IMPD at First in-Human through registration (NDA/MAA) and post approval for life cycle maintenance. She is also responsible for engaging with regulatory authorities, developing CMC strategies, and maintaining alignment with quality, compliance, and regulatory guidance. Additionally, she holds expertise in dosage form commercial nomination, process development and scale up, with a particular focus on biopharmaceutics and age-appropriate dosage form design. She has a BSC (hons) in Biochemistry and is an active member of MTOPRA and the International Consortium for Innovation and Quality in Pharmaceutical Development, API sub team. Paul Marshall Paul is a Director of Global Regulatory Affairs CMC at Jazz Pharmaceuticals, working in early phase development and commercial, and is a Commissioner at the British Pharmacopoeia, chairing Medicinal Chemistry Expert Advisory Group 1 and Radioactive Materials and Excipients Panels. He is a Fellow of TOPRA. Paul is a former Senior Pharmaceutical Assessor in the MHRA Licensing Division for over 10 years. He supported the CEP scheme as an Expert Assessor for 6 years and member of EDQM Technical Advisory Board for 3 years. Paul chaired the CHMP/CMDh working group on ASMF procedures and was integral in developing the worksharing procedure. He has worked in the pharmaceutical industry as a regulatory and pharmaceutical consultant and senior formulation scientist for over 15 years. Paul has published chapters on product stability and stability testing of in Aulton's Pharmaceutics: The Design and Manufacture of Medicines and common deficiencies in the stability dossier and ways to improve in Methods for Stability Testing of Pharmaceuticals. Paul read pharmacy for his graduate degree and researched the internal properties of the bioadhesive bond for his doctorate thesis, both at the School of Pharmacy, University of Nottingham. Alejandro Monton Silva Alejandro Montón Silva’s PhD and Postdoc positions were related to antibiotic development and antibiotic resistances. He has been with the MEB for 3.5 years as their Quality Assessor. Prior to this, Alejandro was a Product Regulatory Affairs Specialist at Smit & Zoon in the Netherlands.