Navigating Pediatric Regulations in the United States and European Union

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Tuesday, November 08, 2011 | 10am BST (UK) / 11am CEST (EU-Central) / 5am EDT (NA)
  • 0 min

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The FDA and EMA’s requirement of pediatric plans for new active ingredients, dosage forms, dosing regimens or routes of administration has made a thorough understanding of such regulations essential. In fact, without a Paediatric Investigational Plan, the EMA will no longer validate any submission.


INC Research is dedicated to helping companies navigate this challenging environment efficiently – so much so that we’re holding a free webinar on the topic during which Klaus Rose and William Sietsema will share their advice on how to create insightful and innovative pediatric strategies that meet these stringent regulatory requirements.


Dr. med. Klaus Rose, MD, MS, Managing Director, klausrose Consulting

Dr. Rose is Managing Director of klausrose Consulting, Basel, Switzerland. He qualified 1986 in medicine in Berlin after studying Latin languages and psychology. He completed postgraduate clinical training in General Medicine in Germany and England and joined pharmaceutical industry in 1991. He held various positions in R&D and medical affairs culminating in the position of Global Head Pediatrics Novartis in 2001 – 2005 and then Global Head Pediatrics Roche 2005 – 2009. From 2010 until March 2011 he was Principal Consultant with Granzer Regulatory Affairs, Munich, Germany.

Dr. Rose is a frequent speaker on international conferences on pediatric drug development and publishes on this theme on a regular base. The second edition of “Guide to Paediatric Drug Development and Clinical Research“, co-edited with Professor van den Anker, was released May 2010.

Married with two daughters, his private interests include Mediterranean cooking, wine, gardening, Latin languages, and classical guitar.

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William Sietsema, PhD Vice President, Regulatory Consulting & Submissions, INC Research, and Adjunct Professor of Pharmaceutical Sciences, University of Cincinnati College of Pharmacy

Dr. Sietsema is VP, Global Regulatory Consulting and Submissions at INC Research and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati, College of Pharmacy. He has 26 years experience in the pharmaceutical industry.

During his fifteen years with INC Research (formerly known as Kendle), he has brought leadership to several initiatives in the fields of inflammation, skeletal disease, analgesia, gastrointestinal disease, and women’s health. He played a pivotal role in the rapid development of Pharmacia’s Celebrex, which transited from beginning of Phase 2 to NDA approval in less than three years. Ethics of pediatric research have been a particular interest of his and he has given lectures and sat on discussion panels for this topic.

He received his BA, magna cum laude, in Chemistry from the University of Colorado, Boulder in 1977 and his PhD in biochemistry from the University of Wisconsin, Madison in 1982. He is the author of more than 35 journal articles, several book chapters, and more than 50 presentations and posters and is an inventor on four patents. He has published four books, one titled Strategic Clinical Development Planning: Designing Programs for Winning Products, another titled Preparation of the New Drug Application: Managing Your Submission in an Era of Changing Global Requirements, a third titled Preclinical Drug Safety Assessment: Practical Considerations for Successful Registrations, and a fourth titled Preparation and Maintenance of the IND Application in eCTD Format. He is a member of the American College of Rheumatology, the American Chemical Society, the Regulatory Affairs Professional Society and serves on the advisory board of Hatton Research. He is on the editorial boards for Regulatory Affairs Professional Society Focus magazine and Scrip Clinical Research. He was recently recognized by R&D Directions as one of the top 20 clinical research scientists.

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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. For more information please visit

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