Advisory Committees
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Agenda for the AquAdvantage Salmon Veterinary Medicine Advisory Committee Meeting
September 19-20, 2010
Sunday, September 19, 2010 -- Orientation
This session will provide a broad overview of the issues with which the Committee should be familiar prior to considering the specific issues of the AquAdvantage salmon. Ample opportunity for questions and answers from Committee members will be provided. Opportunities for clarifying questions and answers will also be provided to the public.
| 1:00 - 1:20 | Welcome | Bernadette Dunham, DVM, PhD |
| 1:20 - 1:40 | The Role of the Committee Member | Aleta Sindelar |
| 1:40 - 2:00 | Genetic Engineering for Animals 101 | Larisa Rudenko, PhD, DABT |
| 2:00 - 2:20 | New Animal Drug Approval Process Applied to GE Animals | Laura Epstein, JD |
| 2:20 – 2:40 | National Environmental Policy Act (NEPA) | Eric Silberhorn, PhD, DABT Animal Biotechnology Interdisciplinary Group |
| 2:40 – 3:00 | Break | |
| 3:00 – 3:20 | Overview of Hierarchical Risk-Based Review Process; Weight of Evidence Approaches; Team-Based Peer Review | Larisa Rudenko, PhD, DABT |
| 3:20 – 4:20 | Guidance 187 Recommendations for Data Presentation | ABIG Scientific Experts |
| 4:20 – 4:30 | Deliberative Process | Aleta Sindelar |
| 4:30 - 5:30 | Questions and Answers from VMAC to Agency Experts |
| Animal Biotechnology Interdisciplinary Group (ABIG) Scientific Experts: | |
|---|---|
| Jay Cormier, JD, PhD Evgenij Evdokimov, PhD Kevin Greenlees, PhD, DABT Barry Hooberman, PhD, DABT Jeffery Jones, DVM, PhD | Kathleen Jones, PhD Donald Prater, DVM Larisa Rudenko, PhD, DABT Eric Silberhorn, PhD, DABT |
Monday, September 20, 2010
| 8:00 | Welcome and Ground Rules | Aleta Sindelar |
| 8:15 | Opening Remarks from CVM Center Director | Bernadette Dunham, DVM, PhD |
| 8:25 | Opening Remarks from CFSAN | Michael Landa, JD |
| 8:35 | Remarks from ONADE | Steven Vaughn, DVM |
| 8:45 | State of World Fisheries | Yonathan Zohar, PhD, Director and Professor Center of Marine Biotechnology, University of Maryland |
| 9:25 | Atlantic Salmon and Risk Issues Associated with Fish | Eric Hallerman, PhD Professor of Fisheries and Wildlife Department Head, Virginia Tech |
| 10:00 | Announcements | Aleta Sindelar |
| 10:15 | BREAK | |
| 10:45 | AquaBounty Technologies | Ron Stotish, PhD, CEO |
| 11:00 | Regulation of GE Animals at FDA | Larisa Rudenko, PhD, DABT |
| 11:20 | Molecular Characterizations of AquAdvantage Salmon | Jeff Jones, DVM, PhD |
| 11:40 | Phenotypic Characterization of AquAdvantage Salmon | Donald Prater, DVM |
| 12:00 | Announcements | Aleta Sindelar |
| 12:15 | LUNCH | |
| 1:15 | Food/Feed Safety Assessment of AquAdvantage Salmon | Kevin Greenlees, PhD, DABT Kathleen Jones, PhD |
| 1:35 | Environmental Assessment for AquAdvantage Salmon | Eric Silberhorn, PhD, DABT |
| 1:55 | Claim Validation | Evgenij Evdokimov, PhD |
| 2:05 | Durability Plan; Post Market Requirements | Jay Cormier, JD, PhD Barry Hooberman, PhD, DABT |
| 2:30 | BREAK | |
| 2:45 | Public Comments to the VMAC | |
| 4:15 | BREAK | |
| 4:30 | Charge to VMAC; Questions of Clarification from VMAC to any Presenters | Larisa Rudenko, PhD, DABT |
| 4:45 | Discussion and VMAC Opinion | Dr. David Senior, VMAC Chair |
| 6:00 | Adjournment | Aleta Sindelar |
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