What ICH E6 (R2) Really Means for Research Sites!
Presented by: Mary McGuire, R.N., Clinical QA Consultant, presenting on behalf of Polaris Compliance Consultants
You’ve heard it before -- the revision to ICH E6 [ICH E6(E2)] includes many new elements; an emphasis on, and revision to, ALCOA principles for study data, validation expectations for computer systems, risk-based trial management, and additional PI oversight responsibilities. What does this all mean, as a practical matter, for research sites? In this webinar, Ms. McGuire will use several extended examples to convey what ICH GCP changes will actually look and feel like at research sites, and how they relate to regulations.
- Sites will be able to assess their procedures in light of the new guidance – they may be closer than they think!
- Sites will understand the changes sponsors and CROs might be asking them to implement – and what’s behind the requests.
- Sites will be provided with discussion points and questions to raise with their sponsors and CROs about their ICH expectations
About the Presenters
Mary McGuire, R.N., Clinical QA Consultant
Mary McGuire is a GCP Quality Assurance specialist, trainer, auditor, and project manager, presenting on behalf of Polaris Compliance Consultants. She is an R.N. with extensive clinical and pharmaceutical experience, and understands both sponsor and investigative site needs. She has over twenty years of experience in Quality Assurance.