Good Clinical Practices & Quality Assurance (GCP-QA)
Yvonne McCracken, Rx Trials Inc and Katharina Kurpanek, The QM Company
Provide a professional, neutral forum for discussing issues and sharing medical, scientific, and regulatory information related to Good Clinical Practices (GCP) in Phase I-IV Clinical Trials, as well as:
- Publicize the field worldwide;
- Stimulate members to engage in the evaluation of GCP quality and compliance issues both in ICH and non-ICH regions;
- Encourage dialogue on GCP issues among regulators, academic institutions, industry, and clinical research and quality assurance Professionals;
- Create, publish, and promote materials on GCP-related issues and topics and on GCP professional development opportunities; and
- Form working groups to keep members updated on such topics as basic GCP concepts, practical quality management system (QMS)components, and GCP auditing methods and techniques.
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Meet the Regulators: Helping You Ensure GCP Compliance
This audiosynchronized presentation brings together regulatory experts from FDA and EMA to share their perspectives on inspections and common areas of GCP noncompliance.
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