Regulatory Authorities and Ethics Committees: Perspectives from Europe for Pediatric Drug Development

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Discovery & Development,
  • Tuesday, September 11, 2012

Regulations have evolved in recent years for pediatric requirements in drug development, with key roles involving regulatory authorities and ethics committees. A recent survey conducted by the EMA among European ethics committees indicated that they have a limited understanding owef the European pediatric regulatory framework. Furthermore, there is still limited awareness of ethical issues related to pediatric research and of involvement of ethics committees, especially in terms of training, education and qualifications to assess protocols for pediatric clinical trials. These same issues can extend to the sponsor community, the negotiation of pediatric investigation plans (PIPs) and the design of clinical trials as well as protocol details.

Join speakers Dirk Mentzer, MD, Member of the Paediatric Committee (PDCO) and Head of Pharmacovigilance Unit at Paul-Ehrlich-Institut, NCA for Vaccine and Sera in Germany, as well as Petra B. Knupfer, MD, MBA, managing director of the ethics committee of the medical association of Baden-Württemberg, Germany for a 60 minute + Q&A webinar session that will address key regulatory expectations and the role of ethics committees in pediatric development.


Petra B. Knupfer, MD, MBA, Managing Director of the Ethics Committee, Medical Association of Baden-Württemberg, Germany

Petra B. Knupfer, MD, MBA was born in Stuttgart, Germany. Since 1999 she is managing director of the ethics committee of the medical association in Baden-Württemberg, Germany.

Dr. Knupfer also is an active member of several work groups of the permanent working party of ethics committees in Germany. She lectures in clinical research at the universities of Tübingen and Hohenheim, Germany, and is a regular referee at various meetings with the competent authorities and pharmaceutical associations. In 2005 she joined the SUSAR work group of EFGCP, since 2010 she is board member of EFGCP.

During her professional life Dr. Knupfer worked as a resident at the departments of surgery and ophthalmology at Katharinenhospital in Stuttgart, as a research assistant in the department of ophthalmology at the University of Madison-Wisconsin, USA, and for several years as an editor at the medical publishers Schattauer and Urban & Fischer, Stuttgart-München.

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Kathy Bohannon Principal Strategist, Pediatrics, INC Research

Ms. Bohannon provides global operational and strategic leadership for INC Pediatrics. She has 16 years of diverse operational and therapeutic experience within pharmaceutical research and development; including Phase I-IV clinical research, laboratory R&D, US and global project management, and sales & marketing. Ms. Bohannon has over 9 years of pediatric research experience including 5 years of pediatric study and program management within the Best Pharmaceuticals for Children Act – Coordinating Center (BPCA-CC) under the purview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Ms. Bohannon has supported development and management of pediatric projects across multiple therapeutic areas (analgesia, cardiovascular, CNS, dermatology, infectious disease, hematology, metabolic disease and respiratory) and clinical settings (inpatient, outpatient, ICU, OR and ER), including rare diseases/orphan indications. Her pediatric experience includes protocol and program development in compliance with FDA PREA and BPCA legislation, and the European Paediatric Regulation; internal team training and management from project initiation through completion; recent presentations examining pediatric research practices and opportunities for further training and education; and strategy development for navigating the challenges of pediatric research.

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Who Should Attend?

Clinical development executives, chief medical officers and other professionals involved in drug development who have interest in further insights in pediatric clinical research.

The webinar will be particularly useful for attendees from biotechnology or pharmaceutical companies worldwide that are seeking to conduct pediatric trials.

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INC Research

INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women’s health trials. The company’s The Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina.

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