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The GCP/GVP work group is an informal forum for discussion, knowledge sharing and networking for members interested in Clinical and Pharmacovigilance activities within the pharma industry.
We discuss the implementation and impact of regulatory regulations/guidelines, news from the inspecting agencies, clarification of upcoming GCP/GPV issues, interfaces to other GXP disciplines, as well as new strategies and approaches for developing skills and standards necessary for meeting the world wide requirements; - often but not necessarily with a basis in Quality Assurance. The group aims to provide a platform for commenting on new regulations, and promote Industry feedback to Inspection Agencies.
We strive to have 3-4 meetings a year. Meeting topics are identified by the participants at the meetings and all members are welcome to participate.
In addition to the meetings, we support Networking activities and by establishing an e-mail string for benchmarking and discussion of GCP/GVP issues.
Chair persons for the GCP/GVP group
Lisbeth Tofte (GVP)
Birthe Nielsen (GCP)