CRED ERP 25

Speaker Biographies

Alex Yates Alex has more than 20 years’ experience in Regulatory Affairs and Drug Development, working in consultancy, large pharma, and currently in small biotech (where he is VP Regulatory Affairs & Development Quality at Bicycle Therapeutics). Alex has led multiple EU procedures and filings for innovative products, orphan drugs, biosimilars and generics, and has experience in strategic engagement with Regulatory Agencies globally. Outside of work Alex is a passionate and published photographer and spends most of his spare time cycling. Jayne Hunt Jayne (FTOPRA) has over 30 years pre and post marketing strategic development & operational regulatory affairs expertise in the EU/UK/US and other countries. This covers experience with ATMPs, biologics, small molecules in a range of semi-virtual, small to medium, and ethical and generic pharmaceutical companies, CROs and consultancy services. Specific experience: European and US pre and post-marketing strategy activities covering: marketing authorisation submissions including legal status considerations and labelling, global clinical trial submission management, CTA & IND submission and ongoing management, orphan drug applications (EU/US), Health Authority Meetings (EMA scientific advice / FDA – Type B-EOP2, Type B, Type C, Health Canada, HPRA, MHRA), fast track & breakthrough & pre-breakthrough applications, PRIME applications and SME support. Matthew Sardo Matthew and has worked within the pharmaceutical industry for 25 years. After starting his career working for the Medicines Control Agency in the UK, he then went on to work for Sanofi-Synthelabo, Alliance Pharmaceuticals and PRA International. During this time he gained experience within pharmacovigilance, medical information, clinical trials, regulatory affairs and quality assurance and has been responsible for advising on regulatory strategy for EU submissions and compilation of MAAs across a number of different therapeutic areas as well as acting as company lead for Scientific Advice meetings. Matthew also has extensive product licence maintenance and technology transfer experience. In addition, through his regulatory work, Matthew has gained experience with a number of QA-related projects including SOP design and authorship, design and setup of Quality Management Systems and various CMC, GDP and GMP-related projects. Matthew moved into consulting ten years ago with his company Sardo Trading Ltd and works with clients on diverse projects including provision of regulatory strategic advice and preparation for Scientific Advice meetings. Through his experience within the quality field Matthew went on to train as a GDP/GMP auditor in 2016 and has assisted and advised upon the setup of EU Quality Management Systems for EU-based clients and conducted GDP/GMP audits. Matthew is also an active member of TOPRA and the Research Quality Association and is the TOPRA Working Party Chair for the European Procedures course run by TOPRA. Matthew can be contacted at: matthew@sardotradinglimited.com Ian Thomson Ian has over 14 years of industry experience in EU and EMEA pharmaceutical Regulatory Affairs (RA). Ian started his career at DLRC regulatory consultancy where he was involved in number of diverse regulatory projects for both generic and innovator pharma companies. Ian then joined the EMEA Oncology/Hematology RA team at Johnson & Johnson (previously Janssen) in 2014 as a Regulatory Scientist and has worked in roles with increasing