APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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In accordance with the GHTF Roles and Responsibilities, Ad Hoc Working Groups may be formed at any time by the Steering Committee for the proper fulfilment of its tasks. Ad Hoc Working Groups shall be appointed by the GHTF Chair with the agreement of the Steering Committee. Members of Ad Hoc Working Groups should represent GHTF Founding Members, Regional Members or Participating Members. Others, such as Liaison Members, may also be considered and be selected on the basis of their expertise in the specific subject matter and should be nominated by the members of the Steering Committee. In exceptional cases, the Ad Hoc Working Group Chair may authorize an individual, with appropriate knowledge and expertise, to participate in an Ad Hoc Working Group meeting(s) as an external observer/expert.
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The GHTF Steering Committee is established under the Procedural Document, "Roles and Responsibilities". As stated in this document, "the role of the Steering Committee is to provide policy direction, strategic planning, and to assign and provide oversight of technical work initiatives". Please see the Strategic Direction document (revised version posted December 19th, 2002) for more information. In addition, the Steering Committee will facilitate progress of work products between GHTF Conferences.
Archive
GHTF Study Group 1 - Pre-market Evaluation documents.
Archive
GHTF Study Group 2 - Post-market Surveillance/Vigilance Documents.
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GHTF Study Group 3 - Quality Systems Documents.
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GHTF Study Group 5 - Clinical Safety/Performance Documents.
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The terminology is always open for Change Requests. The process is outlined in the figure below.