Angela Stokes has worked in a regulatory capacity for more than 30 years in both start-up and large pharmaceutical companies and CROs worldwide and has experience in a wide range of different indications and therapeutic areas. Her experience spans US, EU, China, Japan and Australia, but she has worked on small projects in many other countries worldwide.
Angela has extensive experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, including NCEs, Biosimilars, ATMPs and generics. She is also familiar with the International Organization for Standardization (ISO) standards for medical devices and in vitro diagnostics. She has been involved in writing global regulatory project plans, global clinical trial and clinical investigation applications, IMPDs, pre-meeting briefing packages, orphan drug submissions, responses to regulatory authorities, pediatric investigational plans, post-marketing safety update reports, gap analyses, IBs, BLAs, NDAs and MAAs to obtain favorable outcomes based on knowledge gained from direct experiences.
Angela holds Bachelors’ degrees in chemistry and mathematical sciences backed up with Masters’ degrees in pharmacology and toxicology. She is a Fellow of the Royal Society of Chemistry (FRSC) and a Fellow of the Organisation of Professionals in Regulatory Affairs (FTOPRA). She has Chartered status as both a chemist and a scientist. She has written several chapters for books on drug development and regulatory affairs and writes for several peer-reviewed journals including the Regulatory Rapporteur. Angela is a speaker on a variety of MSc and other courses and presents at global conferences on a regular basis. Angela was honored with a TOPRA award for Regulatory Excellence in 2015, she was the President of TOPRA throughout 2018 and has previously been a member of the TOPRA board for 13 years.