Chair's Advisory Group

The inaugural meeting of the Chair’s Advisory Group (CAG) was held in Washington, DC on 16-17 February 1999.

At that meeting, plans (including the suggested conference schedule and the plenary session agenda) for the 7th Meeting of the GHTF, set for June of that year in Bethesda, Maryland were discussed. In addition, the group was introduced to a draft document, prepared by the Food and Drug Administration (FDA) entitled GHTF Guiding Principles and Operating Procedures which proposed an organizational structure for the GHTF and procedures to be followed for document advancement and endorsement.

The second meeting of the CAG was held during the 7th Meeting of the GHTF in June 1999 and brought regulatory representatives from Japan, Australia, the United States, Canada and the European Union to the table. At that meeting, a second draft of the GHTF Guiding Principles and Operating Procedures document was presented (produced following comments from Japan and Canada) and representatives from the European Union also presented a proposal for the organizational structure of the GHTF.

Comments from industry representatives at the Plenary Session about their lack of involvement in developing the FDA draft document and the existence of the European proposal prompted the GHTF Chair, Dr. Elizabeth Jacobson, to propose the establishment of a joint industry and regulatory working group to examine the issues of document development, organizational structure, etc. The group would be asked to review all the existing procedural documents and comments and to propose a defined set of practices and procedures whose adoption could be discussed at the 8th Meeting of the GHTF.

Ms Beth Pieterson from Health Canada, volunteered to chair the Ad Hoc Procedures Group (as it came to be called) as part of her role as incoming GHTF Chair.