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Drugs and Health Products

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)

Acronyms

BGTD
Biologics and Genetic Therapies Directorate
CTO
Cells, Tissues, and Organs
EAC-CTO
Expert Advisory Committee on Cells, Tissues, and Organs
HPFBI
Health Products and Food Branch Inspectorate
MDB
Medical Devices Bureau
OPIC
Office of Policy and International Collaboration