DIA Conferences Explore the Life Cycle of Maternal and Pediatric Drug Safety October 12-14 in Bethesda, MD

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The Drug Information Association will host two co-located conferences that will provide solutions to the challenges involved in constructing and conducting global pediatric and maternal drug safety programs.

The Drug Information Association will host two co-located conferences that will provide solutions to the challenges involved in constructing and conducting global pediatric and maternal drug safety programs.

Maternal and Pediatric Drug Safety Symposium
October 13-14, 2010
DoubleTree Hotel and Executive Meeting Center
Bethesda, MD

PROGRAM CHAIRPERSON

Diego F. Wyszynski, MD, MHS, PhD        
Global Safety Medical Director and Head, Maternal and Pediatric Safety
Amgen, Inc

PROGRAM COMMITTEE
Elizabeth B. Andrews, PhD, MPH        
Vice President, Pharmacoepidemiology and Risk Management
RTI Health Solutions

Christina Chambers, PhD, MPS        
Associate Professor, Pediatrics and Family and Preventive Medicine
University of California San Diego

Karen B. Feibus, MD, FACOG        
Medical Team Leader, Maternal Health Team
Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Karen D. King, MBA
Global Safety Manager, Maternal and Pediatric Safety
Amgen, Inc.

Sonja A. Rasmussen, MD, MS        
Senior Scientist, Division of Birth Defects and Developmental Disabilities, NCBDDD
Centers for Disease Control                    

Kristine Shields, MSN, MPH        
Director, Clinical Risk Management and Safety Surveillance
Merck & Co., Inc

Wayne R. Snodgrass, MD, PhD        
Professor, Pediatrics
Pharmacology-Toxicology and Obstetrics- Gynecology
Head, Clinical Pharmacology-Toxicology Unit
University of Texas Medical Branch

Robert M. Ward, MD, FAAP, FCP        
Director, Pediatric Pharmacology Program
University of Utah

Join Leaders from Industry, Academia, Industry, FDA, CDC, EMA, and WHO to Discuss Emerging Topics in Maternal and Pediatric Drug Safety.

Maternal and pediatric drug safety is becoming increasingly important areas in the life cycle of medical compounds. Recent regulatory guidelines and scientific findings have emphasized the need to collect, analyze, and report data of the highest quality to healthcare providers and patients. You will leave this symposium with a solid understanding of:

  •     Scientific challenges of maternal and pediatric drug safety
  •     Pros and cons of various methods of drug safety assessment in pregnancy, lactation, and pediatrics
  •     Recent regulatory actions in the maternal and pediatric areas
  •     How to assess maternal and pediatric drug safety
  •     Situations where the benefits of vaccination during pregnancy outweigh the potential risks
  •     When a lactation study is needed and how to communicate the results to the public
  •     How to treat the pediatric population

FEATURED TOPICS

  •     Methods for Drug Safety Assessment in Pregnancy
  •     Regulatory Aspects in Pregnancy
  •     Vaccines in Pregnancy
  •     Drug Effects on Breastfeeding
  •     Different Age Groups, Different Risks
  •     Assessing Drug Safety in the Pediatric Population
  •     Regulatory Issues in the Pediatric Population
  •     US-EU Harmonization

WHO SHOULD ATTEND
Professionals involved in:

  • Academic Health Centers
  • Clinical safety and pharmacovigilance
  • Clinical research and development
  • Regulatory affairs
  • Managed health care
  • Medical/Scientific writing
  • Nonclinical safety and efficacy/toxicology

LEARNING OBJECTIVES

  •     Explain how the US and European regulations apply to the assessment of drug safety for pregnant or breastfeeding women and the pediatric population
  •     Describe the potential risks and benefits of vaccination during pregnancy
  •     Outline the consequences of drugs on breast milk composition and the potential effects on a breastfeeding infant
  •     Discuss the inherent characteristics of the pediatric population with regard to drug metabolism and how to evaluate adverse events in age-appropriate groups

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Joe Krasowski
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