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Wednesday, June 21 • 4:00pm - 5:15pm
#378: Looking to the Future for EU Pediatric Investigation Plans

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-552-L04-P; CME 1.25; IACET 1.25; RN 1.25

EU pediatric investigation plans (PIPs) have become a routine part of the global drug development process. Small and medium-sized US companies that develop new and efficacious drugs are less prepared for the enthusiastic pediatric requirements from the European Medicines Agency. As a consequence, once they approach EU registration, they give in more to EMA's PIP requirements than would be necessary. Even large companies are unable to avoid commitment to questionable studies in children. This has become a serious obstacle in the development of efficacious new drugs, and industry needs better arguments to push back requirements that are expensive and do not improve child health. In 2017 there will be a new report on the EU pediatric legislation to the EU parliament. While the EMA and EU Commission will report on its successes (more PIPs, more clinical trials in children), there are concerns being voiced about having even stronger pediatric obligations from the pharmaceutical industry. This session will focus on the need for better PIP analysis, analysis of lessons learned, and reflections on how to modify the EUPL, while offering a chance for a substantial improvement in industry’s relationship with clinicians and parents. It will also examine how we can prepare the groundwork for countering new proposals to impose stronger pediatric obligations in the EU and US.

Learning Objectives

Discuss the need for better PIP analysis and analysis of lessons learned.


Grant Strachan, LLM


Growing up With the EU Pediatric Regulation: The Opportunities and Obstacles of Developing Pediatric Medicines in Europe
Grant Strachan, LLM

European Pediatric Investigation Plans (PIPs) Need Better Scientific Processing by Pharmaceutical Industry
Klaus Rose, MD, MS

A Comparison of the US and EU Pediatric Regulatory Requirements and the Impact to Global Drug Development
Melodi J McNeil, MS, RPh

avatar for Marie Manley

Marie Manley

Partner and Head of the Regulatory Practice, Bristows LLP
Maria Isabel, Partner & Head of the Regulatory Department at Bristows LLP, specialises in European & UK regulatory and competition law in the bio-pharmaceutical and medical devices sectors. Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise... Read More →

avatar for Melodi McNeil

Melodi McNeil

Director, Regulatory Policy and Intelligence, AbbVie, United States
Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Klaus Rose

Chief Executive Officer, klausrose Consulting
Klaus Rose, a German MD with postgraduate degrees in General & Pharmaceutical Medicine, was 20 years with Big Pharma. In 2001, he became Global Head Pediatrics at Novartis & 2005 at Roche ; CEO of klausrose Consulting since 2011. He advises on pediatric drug development and FDA/EMA... Read More →

Grant Strachan

Senior Associate, Regulatory, Bristows LLP
Grant Strachan is a Senior Associate in the IP Regulatory Practice at Bristows LLP. Grant advises on both contentious and non-contentious EU and UK regulatory law in the healthcare and life sciences sector. This includes: advising on clinical trials; transparency and clinical data... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm CDT
S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  07: SpecialPops, Session