Learning Objectives: At the end of this presentation, audience members will be able to: 1) Understand the concept of endocrine disruption and its particular importance for developing children; 2) Name at least 3 chemicals for which convincing evidence of endocrine disruption exist; 3) Understand why thyroid hormone disruption is of concern particularly for the developing fetus; and 4) Describe results from recent studies investigating the potential of common chemicals to disrupt thyroid hormone as well as the implication of such results.

Learning Objectives: Learning Objectives: Attendees will learn about how auditory startle habituation is assessed in DNT studies, and will gain an improved understanding of the biological relevance of specific measured parameters as well as the issues involved in statistical analysis of auditory startle habituation data.

Learning Objectives: This talk will describe current guidelines for developmental neurotoxicity testing of environmental chemicals and pharmaceuticals. Issues of study conduct, reporting, and evaluation will be discussed. Case studies of learning and memory test data will be presented to illustrate issues with poor reporting, variable data, and inconsistent assessments. The attendee will learn about scientifically based evaluations of these data for regulatory purposes.

Learning Objectives: Attendees will better understand the contributions of medically-assisted conception to all US births. Among in vitro fertilization births (IVF), the effect of number of embryos transferred and early fetal losses on perinatal outcomes will be discussed.

Break

States Monitoring Assisted Reproductive Technology (SMART) Collaborative: Promoting State-Based Surveillance of ART and Infertility

Congenital Heart Defects
Seema R. Lalani, Baylor College of Medicine
Learning Objectives: At the end of the session, the learners will be able to identify important genetic and environmental determinants underlying congenital heart defects.

Infantile Hydrocephalus as a Complex Interplay between Genetic and Environmental Risk Factors
Hannah Tully, Seattle Children’s Hospital
Learning Objectives: At the end of this presentation, the audience will be familiar with the main subtypes of pediatric hydrocephalus and their relative frequencies, recognize the major genetic and environmental causes of hydrocephalus, and discuss the interplay between intrinsic and extrinsic risk factors.

Genetics and Gene-Environment Interaction from the Epidemiologic Perspective
Suzan L. Carmichael, Stanford University
Learning Objectives: At the end of the talk the audience will recognize some basic epidemiological principles important to conducting population-based studies of the contribution of genetic and environmental exposures to birth defects risks.

Overview of the Pregnancy and Lactation Labeling Rule
Leyla Sahin, US Food and Drug Administration
Learning Objectives: To understand the new format for pregnancy and lactation labeling of prescription medications.

Break

Clinical Data in the Label: Evaluating Sources of and Reliability of Clinical Data
Christina D. Chambers, University of California, San Diego
Learning Objectives: To understand the expectations for the inclusion of clinical data in prescription drug labeling.

Considerations for Populating the Lactation Section, 8.2
Jason Sauberan, Rady Children’s Hospital San Diego
Learning Objectives: To understand the data needed to evaluate benefit /risk assessments for prescription drug use during lactation.

Translating the New Labels to the Patient: A Clinician’s Perspective
Megan E. B. Clowse, Duke University
Learning Objectives: To interpret and use the new format of labeling in the decisions for prescription medication use during pregnancy and lactation.

Birth Defects and Cerebral Palsy
Karin B. Nelson, National Institute of Neurological Disorders and Stroke (ret.)
Learning Objectives: Participants will learn that major birth defects recognized by early childhood are the most powerful risk factor known for cerebral palsy (CP) in infants born at term or near term, in whom three-quarters of CP arises; birth defects markedly exceed birth asphyxia, infection/inflammation, or a combination of these as predictors of CP. CNS abnormalities including congenital microcephaly, and cardiac defects, are the most common birth defects in CP. Participants will know that fetal growth restriction, also an important prenatal factor influencing CP risk, is apparently related to CP chiefly through its association with birth defects.

The Causation and Prevention of Cerebral Palsy
Nigel Paneth, University of Michigan
Learning Objectives: To have an appreciation for the descriptive epidemiology of CP, its prevalence in different parts of the world, and temporal trends of recent decades. To learn about the major risk factors of CP. To appreciate that some major risk factors, such as preterm birth and birth asphyxia may not always present primary causes, but may be one the pathways form factors operation earlier in gestation. To be aware of new research approaches to CP. To be aware of new approaches to the prevention of CP in term and preterm infants.

Neuroprotection and Treatment of Cerebral Palsy
Michael V. Johnston, Kennedy Krieger Institute
Learning Objectives: Participants will learn about that the most common brain mechanisms of causation of cerebral palsy and how these mechanisms can be blocked to prevent or treat the disorder. Mild hypothermia administered within 6 hours of birth and continued for 3 days has been shown to reduce CP from asphyxia. In the laboratory, anti-inflammatory agents can also prevent CP caused by inflammation. This treatment is effective in animals when the drug is delivered by dendrimer nanoparticles after the insult has occurred.

Improving the Assessment of Endocrine Disrupting Chemicals (EDC) Effects on Puberty
Tammy E. Stoker, US Environmental Protection Agency
Learning Objectives: Attendees will learn about pubertal development and the potential targets of endocrine disrupting chemicals during this maturational process. Discussion will focus on the current in vivo protocols for evaluating these perturbations and the usefulness of molecular and in vitro measures that could be used as predictors of EDC insult.

Clinical Perspectives on Environmental Influences on Pubertal Timing
Mary M. Lee, University of Massachusetts Memorial Children’s Medical Center
Learning Objectives: This talk will review clinical aspects of assessing puberty, including a discussion of evidence for trends for an apparent earlier presentation of sexual maturation in children as well as possible causes for this shift and the noted pattern for gender differences. A possible role for endocrine disruptors in this acceleration of puberty and their influence in the mechanistic hormonal control of puberty will close out the presentation.