ENVESTIA - Key Persons
Ian is a physician whose career began in paediatrics and general practice. He then spent 5 years as a full-time investigator in a clinical trials unit and has more than 25 years consulting experience within the service industry.
He has been an investigator in more than 50 trials, has designed and implemented clinical development plans for more than 80 products and has medically supervised complete regulatory submissions for 16 MAAs and 1 NDA together with associated responses to expert committees.
He has presented training courses in paediatric and adult drug development, medical writing, regulatory topics and statistics as well as several therapeutic areas.
In 1998 he was elected a Fellow of the Faculty of Pharmaceutical Medicine and currently acts as a Senior Specialty Advisor in the Faculty's Pharmaceutical Medicine Specialist Training programme.
Steve qualified in biochemistry before completing a PhD and post-doctoral work in molecular genetics.
He began his regulatory career with Smith & Nephew before moving to Chauvin Pharmaceuticals where he managed clinical research and drug safety functions in addition to the regulatory team.
In 1998 Steve joined Phoenix International to lead and develop the European regulatory group.
He went on to become Global Head of Regulatory Affairs and Drug Safety for MDS Pharma Services.
Steve's regulatory expertise is focused on the clinical area, most notably in scientific advice, orphan drugs, paediatric investigation plans, development planning, elaboration of regulatory strategy and preparation of clinical overviews and summaries.
He is a regular trainer on clinical development topics for TOPRA and has also presented at numerous other symposia in Europe, US and Japan.