New leadership for medtech regulatory advisory group

AusBiotech has recently appointed Dr Darren Forrest, Director of Quality & Regulatory Affairs ANZ, Medtronic Australasia Pty Ltd 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 an 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 & Regulatory Affairs, Starphama Pty Ltd
  • Sarah Henderson, Regulatory Affairs Manager, Accelagen Pty Ltd
  • Veronica Lewis, Head of Regulatory Management and Trade Compliance – Australia & New Zealand, Merck Group Pty Ltd
  • Manuel Urena, Director Regulatory Affairs, APAC, Cochlear Ltd
  • Yervant Chijian, Director, Team Lead Medical Devices/IVD, Australia, PharmaLex Pty Ltd

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.

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