• Statistical Implications of Withholding Study Medication on the Outcome of Microbicide Trials - Douglas Taylor, PhD 

Thursday March 2, 2006

Session 1: Pharmaceutical Industry / Investigator / Community Perspectives on Safety Monitoring in Trials

• Monitoring Clinical Trials: The Large Pharma Perspective - Garrett Nichols, MD

• Small Parma Perspective on Microbicide Safety - Albert Profy, PhD

• Microbicide Safety: An Investigator’s Perspective - Mike Chirenje, MD

• Community Perspectives on Safety Monitoring in Microbicide Trials - Rhonda White

Session 2: Regulatory Perspectives

• Safety Considerations in Microbicide Trials: The FDA Perspective - Deborah Birnkrant, MD

• Microbicide Safety Reporting: A European Perspective - Ian Weller, MD, FRCP

• Post-Trial, Post Licensure Safety Reporting - Timothy Farley, MD

• Ethics & Microbicide Safey - Keymanthri Moodley, MD DPhil

Friday March 3, 2006

Session 3: Optimizing Safety and Efficacy Endpoints in Microbicide Trials

• Retention and Product Adherence in Microbicide Trials - Deborah Donnell, PhD

• Gynecological Issues in Microbicide Studies - Brynna Harwood, MD

• Pregnancy and Microbicide Studies - Courtney Schreiber, MD

Session 4: Rectal Safety Assessment

• Rectal Safety Assessment - Ian McGowan, MD, PhD, FRCP

• Emerging Epidemiology on Anal Intercourse - Pamina Gorbach, MHS, DrPH

Plenary:

• Keeping the Promise: The Urgent Need to Define Safety and Effectiveness of Microbicides - Sharon Hillier, PhD