Pregnancy Registry Workshop Presentations

2012 Pregnancy Registry Workshop	52nd Annual Meeting, June 23 - July 27, 2012 Baltimore, Maryland
Pregnancy Registries: Lessons Learned and Opportunities Ahead	Melissa S. Tassinari, U.S. Food and Drug Administration
What Should Pregnancy Registries Use for a Comparison Group(s)?	Sonia Hernandez-Diaz, Harvard School of Public Health
Pregnancy Registries and REMS: Opportunities for Collaboration	Vincent T. Armenti, Thomas Jefferson University
Conducting Global Pregnancy Registries: Challenges and Opportunities	Deborah Covington, Pharmaceutical Product Development, Inc.
How Can Pregnancy Registries Work with/Complement Other Sources of Clinical and Observational Information? How Does a Registry Fit in An Overall Plan to Obtain Information?	Sara A. Ephross, GlaxoSmithKline
Interpreting Data from Pregnancy Registries: Who, When, and How?	Janet D. Cragan, Centers for Disease Control and Prevention and Sara H. Riordan, Navigenics, Inc.

2011 Pregnancy Registry Workshop	51st Annual Meeting, June 25th - 29, 2011 San Diego, CA
Use of Control Groups	Moderator: Vincent T. Armenti, Thomas Jefferson University
Controls for Pregnancy Registry	Lewis B. Holmes, MassGeneral Hospital for Children
A Sample Size Calculation Method for Spontaneous Abortion in Observational Studies	Xu R, Chambers C. University of California, San Diego, La Jolla, CA, United States.
The Xolair Pregnancy Registry (EXPECT): Design of an Observational Study of Safety of (Omalizumab) During Pregnancy in Women With Asthma	Namazy J1, Miller MK2, Wang V2, Gershman A2, Andrews E3. 1Scripps Clinic, San Diego, CA, United States, 2Genentech, Inc., South San Francisco, United States, 3RTI Health Solutions, Research Triangle Park, United States.
National Transplantation Pregnancy Registry (NTPR): The Use of an Internal Control Group to Identify a Specific Pattern of Malformation	Termini SM, Helms MC, Coscia LA, McGrory CH, Armenti VT. Thomas Jefferson University, Philadelphia, PA, United States.
Inclusion/Exclusion of Specific Cardiac Defects in Birth Defects Research	Moderator: Kenneth Lyons Jones, University of California, San Diego
Selecting Congenital Heart Defects in Birth Defects Research: Biology vs. Budget	Angela Lin, Genetics Unit, Mass General Hospital for Children
Pregnancy Outcome and Fetal Malformation Risk of Women with Epilepsy: Pregnancy Registry Based Experience from Kerala, India	Thomas SV, Syam UK, Asha PT, Sucharitha DJ, Sabarinathan S, Sarma PS. Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala State, India.
Using ICD-9 Codes in Discharge Diagnoses to Establish Prevalence of Malformations in Newborn Infants	Holmes LB, Westgate M-N. MassGeneral Hospital for Children, Boston, MA, United States.
Evaluation of Congenital Defect Rates from an Insurance Claims Database and an Electronic Health Record Database: Comparison to US National Prevalence Estimates	Wurst KE, Ephross SA. GlaxoSmithKline, Research Triangle Park, NC, United States.
Lost to Follow-up Classification and Analytic Implications in Pregnancy Exposure Registries	Covington DL, McKain LF, Golembesky A, Churchill P. PPD, Inc., Wilmington, NC, United States.
Communicating Risks to the Public	Moderator: Dee L. Quinn, University of Arizona
Communicating Risks to the Public	Jan M. Friedman, University of British Columbia
Pregnancy Drug Safety Information and Surveillance for Type 2 Diabetes Drugs	McKain LF, Covington DL. PPD, Inc., Wilmington, NC, United States
Pregnant Women’s Feelings toward Flu Vaccination While Breastfeeding	Gorman JR, Chambers CD. University of California San Diego, La Jolla, CA, United States.
Infant Outcomes among Critically Ill Pregnant Women with Laboratory-Confirmed Influenza during the 2009 H1N1 Influenza Pandemic	Speaker: Sonja A. Rasmussen, Centers for Disease Control and Prevention Newsome K1, Williams J2, Rasmussen SA2, Callaghan W3, McIntyre A4, Hill H5, Way S1, Honein M2, Jamieson D3, Zotti M3, Finelli L4. 1SciMetrika LLC, Research Triangle Park, NC, United States, 2National Center on Birth Defects and Developmental Disabilities, CDC, Atlanta, GA, United States, 3National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, GA, United States, 4National Center for Immunization and Respiratory Diseases, Atlanta, GA, United States, 5RTI International, Research Triangle Park, NC, United States.

2010 Pregnancy Registry Workshop	50th Annual Meeting, June 26 - 30, 2010 Louisville, Kentucky
Classifying Birth Defects in Reproductive Research	Lewis B. Holmes, MassGeneral Hospital for Children
Methodological Challenges in Surveillance of Spontaneous Abortion As a Reproductive Health Endpoint	David A. Savitz, Mt. Sinai School of Medicine
Studying Miscarriage Using Pregnancy Registries	De-Kun Li, Kaiser Permanente Medical Group
Organizing Pregnancy Registries during an Emergency Response	Ava Marie S. Conlin, Naval Health Research Center
The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS): Launch of a New System for Post-Marketing Surveillance	Christina Chambers, University of California, San Diego
Panel Discussion: FDA Pregnancy Registry Guidance Document Revisions	Moderator: Melissa S. Tassinari, U.S. Food and Drug Administration
Universal Call Center for Medicine Use in Pregnancy	Michael McDonagh, CKR Consulting
Birth Defect Categorization Systems Employed by Pregnancy Registries	Covington DL, McKain LR, Hurst N. Pharmaceutical Product Development Inc., Wilmington, NC, United States.
Pregnancy Drug Safety Labeling and Surveillance at the Time of Product Approval	McKain LF, Covington DL. Pharmaceutical Product Development, Inc., Wilmington, NC, United States.
Comparative Safety of Topiramate during Pregnancy	Hernandez-Diaz S1, Mittendorf R2, Holmes LB3. 1Harvard School of Public Health, Boston, MA, United States, 2Loyola University Chicago, Chicago, IL, United States, 3MassGeneral Hospital for Children, Boston, MA, United States.
UCB Antiepileptic Drug Pregnancy Registry	Scheuerle A1, Harden C2, Alekar S3, Leppik I4, Montouris G5. 1Tesserae Genetics, Dallas, TX, United States, 2University of Miami School of Medicine, Miami, FL, United States, 3UCB, Inc., Raleigh, NC, United States, 4University of Minnesota, Minneapolis, MN, United States, 5Boston University School of Medicine and Boston Medical Center, Boston, MA, United States.
Medication Exposure in Pregnancy Risk Evaluation Program	Li DK1, Andrade S2, Scott P3, Cheetham C4, Cooper W5, Davis R6, Dublin S7, Pawloski P8, Raebel M9, Smith D10, Toh D11. 1Kaiser Permanente Northern California, Oakland, CA, United States, 2Meyers Primary Care Institute, Worcester, MA, United States, 3U.S. Food and Drug Administration, Silver Spring, MD, United States, 4Kaiser Permanente Southern California, Los Angeles, CA, United States, 5Vanderbilt University School of Medicine, Vanderbilt University School of Medicine, United States, 6Kaiser Permanente Georgia, Atlanta, GA, United States, 7Group Health Center for Health Studies,, Seattle, WA, United States, 8HealthPartners Research Foundation, Bloomington, MN, United States, 9Kaiser Permanente Colorado, Denver, CO, United States, 10Kaiser Permanente Northwest, Portland, OR, United States, 11Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, United States.

2009 Pregnancy Registry Workshop	49th Annual Meeting, June 30 - July 1, 2009 Puerto Rico
Introduction	Speaker: Lewis B. Holmes, MassGeneral Hospital for Children
Variability across Current Pregnancy Registry Designs: Impact on Interpretation of Results	Speaker: Laura McKain, Kendle International
Pregnancy Exposure Registries in Resource Limited Settings in Africa, Asia and Latin America	Speaker: Melba Gomes, World Health Organization
Signal Detection Rules across Pregnancy Registries: Do They Make Sense?	Speaker: Deborah Covington, Kendle International
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
How to Design a Pregnancy Registry for a Suspected Human Teratogen	Speaker: Sonja Rasmussen, Centers for Disease Control and Prevention

 

 

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