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Medical Devices / Regulatory Affairs

TGA Overhauls Advisory Committee Confidentiality, Conflicts of Interest Guidance

May 15, 2018

Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees — including the Advisory Committee for Medical Devices — overhauling the guidance with major content and structural changes.

Committee members must first sign a “deed of undertaking” that declares they have no possible conflicts or interests that may give rise to one, other than those declared in a member’s annual declaration of interests form. The deed also declares that the member must not use or share confidential information with anyone outside the committee without prior approval.

Committee members should declare both financial and non-financial interests, the TGA advises. Direct financial interests include, but are not limited to, shares, consultancies, contracts, sponsorships, grants, board memberships, partnerships, trusts and patent ownership.

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