RK KFC F2F Jan 12 2011 FinalDraft AGENDA 01062011v2

							                   CTSA Regulatory Knowledge Key Function Committee
                                  Face-to-Face Meeting
                    Making Collaborative Regulatory Support a Success

                                          January 11-12, 2011
                                              Multiple locations:
                  Jan 11, 2011:   Mykonos Grill, 121 Congressional Lane, Rockville, MD 20852
                  Jan 11, 2011:   Rockville Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852
                  Jan 12, 2011:   Fishers Lane Conference Facility, 5635 Fishers Lane, Rockville, MD 20852
                                      Rooms 508-510 Terrace (lower) Level

                                            DRAFT AGENDA
       TUESDAY, JANUARY 11, 2011 (optional dinner)**
       Mykonos Grill, 121 Congressional Lane, Rockville, MD 20852

       6:45 PM                Depart Rockville Hilton Hotel
                              Walking distance is .4 miles. Participants may also go by taxi.

       7:00 PM                Informal Dinner
                              Mykonos Grill, 121 Congressional Lane, Rockville, MD 20852
                              Join meeting participants to network and to begin exploring topics for affinity groups
                              **Dinner is optional. The cost is $30 per person, payable upon arrival at the
                              restaurant.

       WEDNESDAY, JANUARY 12, 2011
       Fishers Lane Conference Facility, 5635 Fishers Lane, Rockville, MD 20852
       Rooms 508-510 Terrace (lower) Level

       7:30 – 8:00 AM         Registration and Light Refreshments

       8:00 – 8:10 AM         Welcome and Introductions
                              Dr. Rhonda Kost, Rockefeller, 2006
                              Dr. Kathryn Schuff, OHSU, 2006

       8:10 – 8:15 AM         Opening Remarks
                              Dr. Barbara Alving, Director, National Center for Research Resources

       8:15 – 9:00 AM         Keynote: A Critical Time for Regulatory Science
                              Dr. Vicki Seyfert-Margolis, Food and Drug Administration

       9:00– 9:20 AM          The Clinical and Translational Science Award Program: An Overview of
                              2010 and a look forward
                              Dr. Anthony Hayward, Director, Division for Clinical Research Resources, NCRR

       9:20 – 10:00 AM        Critical Needs for Clinical Research Coordinator Training Support and
                              Career Development
                              Papers, Survey Results, and Question and Answer Session
                              Dr. Lisa Speicher, Children’s Hospital of Philadelphia

      10:00 – 10:15 AM                Break

Updated January 6, 2011
       10:15 – 12:10 PM      CTSA Regulatory Successes: Overview and Panel Discussion (Session I)
                             Research Subject Advocacy, Recruitment and Retention, Research
                             Participant Survey
                             Dr. Rhonda Kost, Rockefeller University, 2006; Dr. Carson Reider, The Ohio State
                             University, 2008; Ms. Sabrena Mervin-Blake, M.S, University of North Carolina, 2008

       12:10 – 1:00 PM       Working Lunch (Discussing Affinity Groups)
                             Boxed lunches from the cafeteria may be pre-ordered at the morning registration.
                             Lunch may also be purchased on your own in the cafeteria on the first floor.

       1:00 – 2:45 PM        CTSA Regulatory Successes: Overview and Panel Discussion (Session II)
                             IND/IDE, GLP, Clinical Trials Registration Tracking
                             Ms. Karen Hartman, R.N., M.S.N, CCRC, Mayo Clinic, 2006
                             Dr. Joan Adamo, University of Rochester, 2006
                             Dr. Bruce Burnett, Duke, 2006
                             Dr. Gregg Fromell, University of Pennsylvania, 2006

       2:45 – 3:15 PM        Activating CTSA Regulatory Affinity Groups
                             Dr. Jody Sachs, NCRR; Mr. Eric Rubinstein, J.D., M.P.H., University of Rochester, 2006

       3:15 – 3:30 PM                Break

       3:30 – 4:30 PM        Open Discussion of Future Directions of Regulatory Knowledge KFC and
                             Strategic Initiatives
                             Dr. Rhonda Kost, Rockefeller; Dr. Kathryn Schuff, OHSU




       Meeting Planning Committee and Administration Key Function Committee Leadership
       Meeting Co-Chairs:    Eric Rubinstein, Rochester, 2006
                             Karen Hartman, Mayo, 2006
       Planning Committee:   Toni D’Agostino, Univ. of Texas Medical Branch, 2009
                             Kate Marusina, UC Davis, 2006
                             Melody Sacatos, Yale, 2006
                             Lisa Speicher, The Children’s Hospital of Philadelphia, 2006
                             Ted Wun, UC Davis, 2006
       KFC Co-Chairs:        Rhonda Kost, Rockefeller, 2006
                             Kathryn Schuff, OHSU, 2006
       NCRR Coordinator:     Jody Sachs, National Center for Research Resources




Updated January 6, 2011