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C Workshop Agenda Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities 7-8 April 1997 Objectives: to review newly available data to consider important ancillary issues to extract generic lessons from a specific case to explore preemptive approaches and mechanisms for introducing new contraceptives in the future DAY ONE-MONDAY, 7 APRIL 1997 8:30 a.m. OPENING STATEMENT, CHARGE TO COMMITTEE, PARTICIPANTS Allan Rosenfield, Chair 8:45 WHAT INTERNATIONAL DATA TELL US NOW: (Committee Rapporteur: Hedia Belhadj) Data and Analysis from WHO/HRP, Family Health International, and Population Council Postmarketing Surveillance Olav Meirik, WHO/HRP Paul Van Look WHO/HRP QUESTIONS AND COMMENTS 10:00 WHAT U.S. DATA TELL US NOW: (Committee Rapporteur: Nancy Buc) Data and Analysis: NICHD and Kaiser-Funded Clinic-Based Studies Andrew Davidson, Columbia University Debra Kalmuss, Columbia University 10:30 Helen Koo, Research Triangle Institute
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11:00 Data and Analysis from 1995 National Survey of Family Growth Jacqueline Darroch, Alan Guttmacher Institute 11:30 Data and Analysis from Population Council Studies Irving Sivin, Population Council 12 noon QUESTIONS AND COMMENTS 12:15 p.m. LUNCH 1:00 A RANGE OF PERSPECTIVES: SOME PREPARED REMARKS AND A DIALOGUE (Committee Rapporteur: Rebecca Cook) Cynthia Pearson, National Women's Health Network Julia Scott, National Black Women's Health Project Ellen Moskowitz, Hastings Center Martha Ellen Katz, Department of Social Medicine, Harvard Medical School; Martha Eliot Health Center, Children's Hospital QUESTIONS AND COMMENTS 2:30 IMPLANT REMOVAL AND TRAINING (Committee Rapporteur: Judy Norsigian) Clinical Issues: David Archer, Eastern Virginia Medical/Jones Institute Case Material: United Kingdom: Angela Davey, Hoechst-Marion-Roussel, United Kingdom with Lynne Gaffikin, JHPIEGO Baltimore: Paul Blumenthal, Johns Hopkins Bayview Medical Center Indonesia: Paul Blumenthal, Ruth Simmons, University of Michigan METHOD COST-EFFECTIVENESS: IMPLICATIONS FOR NEW FORMULATIONS (Committee Rapporteur: David Mowery) Felicia Stewart, Kaiser Family Foundation QUESTIONS AND COMMENTS BREAK ad libitum
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3:30 BIOCOMPATIBILITY, MEDICAL APPLICATIONS OF SILICONE-BASED MATERIALS: REVIEW OF PERTINENT FINDINGS (Committee Rapporteur: Donald McDonnell) James Anderson, Case Western Reserve Noel Rose, Johns Hopkins VAGINAL HIV/SIV TRANSMISSION Monkey SIV Data: Preston Marx, Aaron Diamond Research Center Human Epidemiologic Data: Ward Cates, Family Health International QUESTIONS AND COMMENTS 5:30 CHAIRMAN'S INSTRUCTIONS, ADJOURNMENT DAY TWO-TUESDAY, 8 APRIL 1997 8:30 SUMMATION: WHAT HAVE WE HEARD? WHERE DOES IT LEAVE US? 9:00 LOOKING TO THE FUTURE A Federal Standards Defense: What Difference Might It Make? Michael Green, Iowa Law Center The Reproductive Health Technologies Project: Objectives and Plans Marie Bass, Bass and Howes, Inc. WHO Strategic Initiative for Introduction of New Methods: Illumination from Early Experience Ruth Simmons 9:45 OTHER PREPARATORY AND PREVENTIVE APPROACHES Lead Discussants: Ruth Macklin, Albert Einstein College of Medicine Marian Secundy, Howard University Program in Clinical Ethics GENERAL DISCUSSION Tutti 12:30 p.m. ADJOURNMENT
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NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE WORKSHOP Implant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities 7 April 1997—Lecture Room 8 April 1997—Members' Room 2101 Constitution Avenue, N.W. Washington, DC 20418 PARTICIPANTS James M. Anderson, MD, PhD Professor of Pathology, Macromolecular Science, and Biomedical Engineering Case Western Reserve University Lisa Angerame Government Relations Manager American Society for Reproductive Medicine Washington, D.C. Felice Apter, PhD Research Division Office of Population U.S. Agency for International Development David Archer, MD Director of Clinical Research The Jones Institute Eastern Virgina Medical College Marie Bass Project Director Reproductive Health Technologies Project Washington, D.C. Paul Blumenthal, MD Associate Professor Johns Hopkins University Bayview Medical Center Willard Cates, Jr., MD, MPH Senior Vice President Biomedical Affairs Family Health International Jacqueline E. Darroch, PhD Senior Vice President Vice President for Research The Alan Guttmacher Institute Angela Davey Head, Medical Information Services Hoechst Marion Roussel Ltd. United Kingdom Andrew R. Davidson, PhD, MBA Center for Population and Family Health Columbia University Judith M. DeSarno President and CEO National Family Planning and Reproductive Health Association Washington, D.C.
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Henry L. Gabelnick, PhD Director Contraceptive Research and Development Program Lynne Gaffikin, PhD JHPIEGO Corporation Baltimore, MD Michael D. Green, JD College of Law University of Iowa Gary Grubb, MD, MPH Director Women's Health Care Wyeth Ayerst Laboratories Diane Harrison, MD, FACOG Director, Clinical Affairs Medical Affairs Department Wyeth-Ayerst Laboratories Stephen F. Heartwell, MD Associate Professor Department of Obstetrics and Gynecology University of Texas Southwestern Medical School (Chair, Norplant Foundation) Stephen Isaacs, JD Center for Health and Social Policy Pelham, New York Lisa Kaeser The Alan Guttmacher Institute Washington, D.C. Debra Kalmuss, PhD Center for Population and Family Health Columbia University Martha Ellen Katz, MD Department of Social Medicine Harvard Medical School Martha Eliot Health Center Children's Hospital Helen P. Koo, PhD Research Triangle Institute Johanna K. Kouru General Counsel Leiras Oy Pekka Lahteenmaki, MD Leiras Oy Ruth Macklin, PhD Professor Department of Epidemiology and Social Medicine Albert Einstein College of Medicine Preston A. Marx, PhD Aaron Diamond AIDS Research Center AIDS Animal Models Laboratory at LEMSIP Christine Mauck, MD Medical Officer Reproductive and Urologic Drug Products Division Center for Drug Evaluation and Research Food and Drug Administration Olav Meirik, MD, PhD Special Program of Research, Development, and Research Training in Human Reproduction World Health Organization Thomas Merrick Advisor for Population Human Development Department The World Bank Ellen Moskowitz, JD Associate for Law The Hastings Center
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Susan F. Newcomer, PhD Sociologist/Demographer Demographic and Behavioral Sciences Branch Center for Population Research National Institute for Child Health and Human Development Cynthia Pearson Executive Director National Women's Health Network Marjorie Powell, JD Assistant General Counsel Pharmaceutical Research and Manufacturers Association Noel Rose, MD, PhD Professor Department of Immunology and Infectious Disease School of Hygiene and Public Health Professor of Medicine Johns Hopkins University Julia R. Scott, RN National Black Women's Health Network Washington, D.C. Marian Gray Secundy, EdD Director, Program in Clinical Ethics Department of Community Health and Family Practice Howard University College of Medicine James Shelton, MD Acting Chief Office of Population Bureau of Science and Technology U.S. Agency for International Development Ruth Simmons, PhD Health Behavior and Health Education School of Public Health University of Michigan Irving Sivin Center for Biomedical Research The Population Council Jeffrey Spieler Chief, Research Division Office of Population U.S. Agency for International Development Robert Spirtas, DrPH Chief Contraceptive Evaluation Branch Center for Population Research National Institute of Child Health and Human Development Felicia H. Stewart, MD Director of Reproductive Health Programs Henry J. Kaiser Family Foundation Sean B. Tipton Director of Public Affairs The Endocrine Society Paul Van Look, MD, PhD Special Program of Research, Development, and Research Training in Human Reproduction World Health Organization Sandra Waldman, MA, MS Director Office of Public Information The Population Council Margaret Weber, MD Senior Director, Clinical Affairs Medical Affairs Department Wyeth-Ayerst Laboratories
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