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Puerto Rico

Joint TS/OTIS Pregnancy Registry Workshop

Tuesday & Wednesday, June 30 - July 1, 2009

You are invited to participate in the second annual workshop on
“Pregnancy Registry Methods - The Challenges of Pregnancy Drug Safety Studies in the Global Environment”

Pregnancy registries

are a key component of many Risk Management Plans for pharmaceuticals
are increasing in number worldwide
yet present many methodological challenges that are common across various registry designs

Join us to hear experts from a variety of pregnancy registries on selected topics, and submit an abstract for the poster presentation/discussion session.

Workshop Only Registration Fees: (Download Registration Form PDF)

Advance Registration: $675*
On-Site Registration: $700*

Joint TS/OTIS Pregnancy Registry Program

Tuesday, July 1, 2009

4:45 PM - 7:45 PM	Joint TS/OTIS Pregnancy Registry Workshop Part 1
	Chairpersons: Christina D. Chambers, University of California, San Diego and Lewis B. Holmes, MassGeneral Hospital For Children

4:45 PM – 4:50 PM	Introduction Speaker: Lewis B. Holmes, MassGeneral Hospital for Children

4:50 PM – 5:05 PM	Variability across Current Pregnancy Registry Designs: Impact on Interpretation of Results Speaker: Laura McKain, Kendle International

5:05 PM – 5:25 PM	Sources of Bias in Pregnancy Registries Speaker: Gideon Koren, The Hospital For Sick Children

5:25 PM – 5:45 PM	Retrospective Versus Prospective Registry Designs: A Place for Both Speakers: Vince Armenti, National Transplant Registry and the Neoral Pregnancy Registry for Psoriasis and Rheumatoid Arthritis

5:45 PM – 6:00 PM	Panel Discussion

6:00 PM - 7:45 PM	Poster Session (Located in the Exhibit Hall)

Wednesday, July 1, 2009

8:00 AM – 12:15 PM	Joint TS/OTIS Pregnancy Registry Workshop Part 2
	Chairpersons: Karen Feibus, U.S. Food and Drug Administration and Diego Wyszynski, Amgen

8:00 AM – 8:20 AM	Pregnancy Exposure Registries in Resource Limited Settings in Africa, Asia and Latin America Speaker: Melba Gomes, World Health Organization

8:20 AM – 8:40 AM	When Is It Time to Close a Pregnancy Registry Speaker: Jan Cragan, Centers for Disease Control and Prevention

8:40 AM – 9:00 AM	Signal Detection Rules across Pregnancy Registries: Do They Make Sense? Speaker: Deborah Covington, Kendle International

9:00 AM – 9:20 AM	The Decision-Making Process during Pregnancy: Impact on Pregnancy Registries Speakers: Sara Eggers, Decision Partners

9:20 AM – 11:15 AM	Platform Session

9:20 AM – 9:35 AM	Pregnancy Outcomes from the Pregnancy Registry for Gardasil® (Human Papillomavirus types 6/11/16/18 vaccine)
	Dana A, Buchanan KM, Goss MA, Seminack MM, Shields K, Haupt RM. Merck Research Laboratories, West Point, PA, United States.

9:35 AM – 9:50 AM	Using Pregnancy Registries to Estimate Spontaneous Abortion Rates
	Roberts S¹, Albano J², McKain L², Covington D². ¹University of North Carolina, Wilmington, NC, United States, ²Kendle International, Inc., Wilmington, NC, United States.

9:50 AM – 10:05 AM	Evaluation of Pregnancy Exposure Registries for Pharmaceuticals
	Cummins SK. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs Immediate Office, Pediatric and Maternal Health Staff, Silver Spring, MD, United States.

10:05 AM – 10:20 AM	National Transplantation Pregnancy Registry (NTPR): Outcomes of Pregnancies in Female Transplant Recipients
	Carll M1, Coscia LA¹, Constantinescu S², Armenti VT¹. ¹Thomas Jefferson University, Philadelphia, PA, United States, ²Temple University, Philadelphia, PA, United States.

10:20 AM – 10:30 AM	Discussion

10:30 AM – 11:00 AM	Warkany Tea/Break

11: 00 AM – 11:15 AM	Comparative Safety of Some Anticonvulsant Polytherapies during Pregnancy Holmes LB¹, Smith CR¹, Shen A¹, Mittendorf R³, Hernandez-Diaz S². ¹MassGeneral Hospital for Children, Boston, MA, United States, ²Harvard School of Public Health, Boston, MA, United States, ³Loyola University Medical Center, Maywood, IL, United States.

11:15 AM – 11:35 AM	Steps toward a National Call Center for Pregnancy Registries Speakers: Karen Feibus, U.S. Food and Drug Administration and Diego Wyszynski, Amgen

11:35 AM – 11:55 PM	How to Design a Pregnancy Registry for a Suspected Human Teratogen Speaker: Sonja Rasmussen, Centers for Disease Control and Prevention

11:55 PM – 12:15 PM	Panel Discussion