Helen is a seasoned Quality and Regulatory professional, responsible for overseeing Global Pharma Solutions’ (GPS) CMC activities. She specialises in CMC regulatory strategy, submission requirements and quality activities, from early clinical development through to registration and life cycle management, for registered medicinal products (OTC and Rx). With over 35 years in the industry, prior to joining GPS, Helen worked for small biotech through to large multi-nationals, covering small molecules, biologics and botanicals. She is experienced at working closely with manufacturing and quality teams to support global regulatory activities for Phase 1 trials though to post approval life cycle management, across a variety of dosage forms. Helen has a wealth of experience working with TGA and FDA, including Australian complementary medicines.

Gaelene Pyke is the Director, OTC Medicines Evaluation Section within the Complementary & OTC Medicines Branch (COMB) at the Therapeutic Goods Administration (TGA) and is currently Acting Assistant Secretary of COMB. Gaelene has extensive experience in the regulation of medicines. Before joining the OTC Medicines Evaluation Section in 1998, she held several other positions within the TGA. Gaelene has been with the TGA since 1994. Prior to joining the TGA, Gaelene worked in Quality Assurance for a pharmaceutical company, in government analytical laboratories and in pathology laboratories. Gaelene has a background in microbiology and analytical biochemistry.

After completing a B.Sc. (Hons) in Human Physiology Kevin worked for the South African Medical Research Council for 3 years, before returning to full time study to complete a B.Pharm. Kevin completed his internship at Eli Lilly in South Africa and has subsequently amassed over 35 years’ experience in the pharmaceutical and medical devices industries, during which time he also gained an MBA from the Edinburgh Business School. Kevin has over 15 years’ experience in compliance, having held compliance roles in Australia, the UK and Europe. He has a deep understanding of industry codes of practice and the Therapeutic Goods Advertising Code (TGAC) and has presented at compliance conferences in the UK and Europe. He also served on the Code of Practice Education sub-committee of the Association of the British Pharmaceutical Industry (ABPI). Kevin is also a training facilitator for TGAC training offered by CHP Australia. Currently he is CHP Australia’s Advertising Compliance Manager, leading the AdCheck team, which provides a compliance check for consumer-facing therapeutic goods advertising.