PRE- Conference -- Sunday, April 3, 2011

AGENT 101 – ROOM:  PACIFICA BALLROOM A
{Scientific Community}

Edward H. You, Supervisory Special Agent
Federal Bureau of Investigation
Weapons of Mass Destruction Directorate

SCIENCE 101 – ROOM:  PACIFICA BALLROOM B
{Security Community}

Claudia Mickelson, PhD
Deputy Director
Massachusetts Institute of Technology
Environmental Health & Safety Office,
Special Advisor to VP for Research

Lynette M. Schenkel
Assistant Vice President
Responsible Conduct of Research
University of Oregon

 

KEY CHALLENGES FACING IACUCs, IBCs & IRBs:

Regulations, Compliance and Biosecurity

Day 1- MONDAY, April 4, 2011

 

Track 1	IACUC
Track 2	IBC
Track 3	IRB
Track 4	GENERAL SESSIONS

 

8:00 am – 12:00 pm	Registration
7:00 am - 8:30 am	Breakfast – GRANDE ROOM
8:15 am	WELCOME! And INTRODUCTIONS MSMR - FBI
8:25 am – 9:25 am Keynote Address Learning Theater		Overview of the Life Sciences and National Security Diane DiEuliis, PhD Senior Policy Advisor National Institutes of Health
9:30 am - 10:15 am Learning Theater		KEY CHALLENGES FACING IACUCs, IBCs & IRBs: Regulations, Compliance and Biosecurity  Edward H. You  Supervisory Special Agent  Federal Bureau of Investigation  Weapons of Mass Destruction Directorate
10:15 am – 10:30 am		AM BREAK –PRE-REGISTRATION AREA
10:30 am – 11:15 am Learning Theater		Biosafety and Biosecurity Risk Assessment Methodologies (BioRAMs) Jennifer M Gaudioso, PhD Principal Member of the Technical Staff International Biological Threat Reduction Program Sandia National Laboratories

11:15 am – 12:00 pm		AM Sessions
		NIH Guidelines: Recent & Proposed Updates Kathryn Harris, PhD Office of Biotechnology Activities National Institutes of Health		Research Repositories and Data Sharing: Legal and Ethical Challenges   Marianna J. Bledsoe, M.A. Senior Program Manager  Biorepository and Tissue Banking Biomedical Laboratory R&D Service Office of Research & Development Department of Veterans Affairs
12:00 pm – 12:45 pm		LUNCH –GRANDE ROOM
12:50 pm – 1:35 pm		PM Sessions
		IACUC Collaborative Compliance: Bridging theory and practice with Post Approval Monitoring   Candice Brotchie-Fine, MA, CPIA Regulatory Compliance Specialist Novartis Institutes for BioMedical Research, Inc.	IBC & IRB   Working on the Learning Curve … What’s your approach? Claudia Mickelson Deputy Director Massachusetts Institute of Technology Environmental Health & Safety Office, Special Advisor to VP for Research Lynette M. Schenkel Assistant Vice President Responsible Conduct of Research University of Oregon
1:40 pm – 2:40 pm		PM Sessions
Learning Theater		The THREE I’s – SECURITY RISK ASSESSMENT Edward H. You  Supervisory Special Agent  Federal Bureau of Investigation  Weapons of Mass Destruction Directorate
2:45 pm – 3:00 pm		PM BREAK – PRE-REGISTRATION AREA
3:00 pm – 4:30 pm		PM Sessions
		The THREE I’s TABLE-TOP EXCERSISES … continued
4:30 pm – 6:30 pm	OLIVE LAWN … NETWORKING RECEPTION

Day 2 - TUESDAY, April 5, 2011

8:00 am – 9:00 am	Registration
7:00 am – 8:30 am	Breakfast –GRANDE ROOM
8:25 am	WELCOME! And INTRODUCTIONS
8:30 am – 9:15 am   Learning Theater		U.S. Government Policy Activities: Promoting a Culture of Responsibility as a Step Toward Risk Mitigation Laura A. Kwinn, Ph.D. Science Policy Advisor Office of Policy and Planning Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services
9:15 am - 10:15 am		AM Sessions
Learning Theater		The THREE I’s … Moving Forward as a Team Marcy Brown, BS, MA, CPIA Regulatory Compliance Worldwide Comparative Medicine - La Jolla Pfizer, Worldwide Research & Development   Bob Hashimoto, BS, MS Biosafety Officer University of California at Berkeley Jeffrey M. Cohen, Ph.D., CIP President HRP Associates, Inc.
10:15 am - 10:30 am		AM BREAK – PRE-REGISTRATION AREA
10:30 am – 11:15 pm		AM Sessions
Learning Theater		The THREE I’s … Moving Forward as a Team continued …
11:15 pm – 12:00 pm		PM Sessions
		Building Connections – Coordination and Communication between IACUCs and IBCs Ted Myatt, ScD, RBP Director Partners Healthcare Institutional Biosafety Committee Kathryn Holthaus, BS, MA, MS Research Compliance Manager Brigham & Women’s Hospital		Evaluating Conflicts of Interest: Investigators and IRB Members   Lynette M. Schenkel Assistant Vice President Responsible Conduct of Research University of Oregon
12:00 pm – 12:45 pm		Lunch – GRANDE ROOM
12:45 pm – 1:00 pm		PM Sessions
		IACUC   SELECT AGENT PROGRAM   TBA	IBC & IRB   SELECT AGENT PROGRAM TBA	IBC & IRB Ethical, Safe, and Secure Research in a Global Scientific Enterprise Kavita Berger, PhD Associate Program Director Center for Science, Technology, and Security Policy American Association for the Advancement of Science
1:05 pm – 1:50 pm		PM Sessions
		The 2011 Guide: What Do the Changes Mean to Your IACUC? Marcy Brown, BS, MA,   CPIA Regulatory Compliance Worldwide Comparative Medicine - La Jolla Pfizer, Worldwide Research & Development	The Future is Here: IRB/IBC Oversight of Research Using Emerging Technologies   Ellyn Segal, PhD Biosafety Manager Stanford University
1:55 pm – 2:10 pm		Afternoon Break – PRE-REGISTRATION AREA
2:10 pm – 4:10 pm		PM Sessions
Learning Theater		CASE STUDIES – THREE Is FBI   Edward H. You  Supervisory Special Agent  Federal Bureau of Investigation  Weapons of Mass Destruction Directorate
4:10 pm – 4:30 pm		CLOSING REMARKS-DISCUSSION & EVALUATIONS

 

 

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