John Watkins is Director, Regulatory Affairs, PPD, UK. He specialises in CMC, Biologics, Biosimilars, Advanced Therapies, GMO Submissions, Vaccines and Therapeutics for infectious diseases, EMA Scientific Advice, EU National RA Scientific Advice, US FDA Pre-IND Meetings, Clinical Trials, Marketing Authorisations (EU CP), US BLA and Immunogenicity,
Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR
European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.