AusBiotech has recently appointed Dr Darren Forrest, the director of quality and regulatory affairs for Medtronic Australasia, as chair of the national AusMedtech Regulatory Affairs Advisory Group.
Dr Forrest has been a contributor to the AusMedtech Regulatory Affairs Advisory Group since 2012. He brings in-depth knowledge and experience regarding the implementation of European and Australian medical device regulations to the Advisory Group. Darren leads regulatory, quality and post-market vigilance at Medtronic to ensure the best technology is available to Australian patients.
Members of the AusMedtech Regulatory Affairs Advisory Group include:
- Rebecca Gaudin, Director of Regulatory Affairs, ANZ, Johnson & Johnson Medical;
- Dr Jeremy Paull, VP Development and Regulatory Affairs, Starphama;
- Sarah Henderson, Regulatory Affairs Manager, Accelagen;
- Veronica Lewis, Head of Regulatory Management and Trade Compliance - Australia New Zealand, Merck Group;
- Manuel Urena, Director Regulatory Affairs, APAC, Cochlear; and
- Yervant Chijian, Director, Team Lead Medical Devices/IVD, Australia, PharmaLex.
The AusMedtech Regulatory Affairs Advisory Group represents members in the medical technology sector providing guidance and advice to AusBiotech on operational and policy-related regulatory matters regarding dealings with the Therapeutic Goods Administration (TGA). Advisory Group members represent AusBiotech at TGA’s RegTech Forums throughout the year to remain informed on major policy issues, which AusBiotech utilises to disseminate information to its membership.
AusBiotech would also like to thank Grant Bennett, Managing Director, PharmaLex for his time as Chair of the Advisory Group after four years of service. Grant remains involved as Chair of AusBiotech’s national AusMedtech Advisory Group.