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.
Dr. John Zibert, Chief Medical Officer Coegin Pharma AB, a listed Nordic biotech company with several unique molecular technologies and compounds , where he also serves as CEO of Avexxin Oncology AS and Board Member of Reccura Therapeutics AS. He received his master’s in medicine and human biology, and PhD in immunology at the University of Copenhagen, DK and University of Otago, NZ. He has demonstrated a successful history of working in the pharmaceutical and digital healthcare industry in established corporate businesses, and in an incubator co-establishing more than 25 start-ups within digital health and biotech, and several of his own biotech companies. Furthermore, he has an academic footprint of 79 publications in particular within digital health, tumor biology and dermatology. He has a deep experience within execution of drug research and development, Decentralized Clinical Trials, digital healthcare solutions, and leadership.
Hans Werink has been working in the plastics industry since 1988. He joined Holland Colours in 1990 and has held several positions in the laboratory, technical service, sales and project management at the headquarters of Holland Colours in the Netherlands.
Currently he is Global Product Manager Dairy and in this position, he is responsible for new developments and market introduction of additives for light-sensitive applications in PET packaging.
Hans has a degree in Industrial Engineering & Management.
Raymond Jongman is Sales Manager EMEA for Holland Colours Division Europe BV with over 15 years of experience in the PET packaging market, ranging from resin production to recycling and colour concentrates.
Raymond holds a Bachelor degree in Chemical Engineering and has been on the forefront of expanding the PET Packaging business for Holland Colours for the last 11 years. Raymond specializes in understanding the needs of customers and anticipating the ever changing regulations and requirements, focussing on bringing innovations to the market. As a father of five, his kids inspire him in their process of growing up. His motto is to never give up, never take things for granted and certainly to not be afraid to think outside of the box – perseverance and creativity pays off.
