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Teleconference of the Expert Advisory Committees on Cells, Tissues, and Organs (EAC-CTO) - Agenda - February 2nd 2012

Place: Health Protection Building, Room 0105
Time: 1:30 pm - 4:00 pm EST

1:30 pm - 1:40 pm Introductions & Opening Remarks (Ms. Angela Briginshaw, A/Director General, BGTD; Ms. Corinne Weernink, Chair, EAC-CTO)

1:40 pm - 1:45 pm Review of Agenda (Ms. Corinne Weernink)

1:45 pm - 1:50 pm Declarations of Affiliations & Interests (Ms. Corinne Weernink)

1:50 pm - 2:10 pm Compliance & Enforcement Strategy (HPFBI)

2:10 pm - 2:25 pm CTO Regulatory Framework Update (OPIC)

  • Guidance revisions
  • Phase II Regulatory Amendments

2:25 pm - 3:10 pm Nucleic Acid Test (NAT) (OPIC)

3:10 pm - 3:20 pm Testing Requirements: Diagnostic vs. Screening (BGTD/MDB)

3:20 pm - 3:35 pm Non-exclusionary Criteria for Cytomegalovirus (CMV) - Diagnostic vs. Screening (OPIC)

3:35 pm - 3:45 pm Review and adjournment (Ms. Corinne Weernink)


Biologics and Genetic Therapies Directorate
Cells, Tissues, and Organs
Expert Advisory Committee on Cells, Tissues, and Organs
Health Products and Food Branch Inspectorate
Medical Devices Bureau
Office of Policy and International Collaboration