New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017

Author:

Ollivier Cécile1,Sun Haihao2,Amchin Wayne2,Beghetti Maurice3,Berger Rolf M. F.4,Breitenstein Stefanie5,Garnett Christine2,Gullberg Ninna1,Hassel Patrik6,Ivy Dunbar7,Kawut Steven M.8,Klein Agnes9,Lesage Catherine10,Migdal Marek11,Nije Barbara9,Odermarsky Michal12,Strait James13,de Graeff Pieter A.14,Stockbridge Norman2

Affiliation:

1. European Medicines Agency London United Kingdom

2. Food and Drug Administration Silver Spring MD

3. Pediatric Cardiology Unit Centre Universitaire de Cardiologie et Chirurgie Cardiaque Pédiatrique University Hospitals of Geneva City of Geneva Switzerland

4. Center for Congenital Heart Diseases Department of Pediatric Cardiology Beatrix Children's Hospital University Medical Center Groningen University of Groningen the Netherlands

5. Bayer AG, Pharmaceuticals, Research and Development Wuppertal Germany

6. PH Sweden Göteborg Sweden

7. Heart Institute Children's Hospital Colorado University of Colorado School of Medicine Aurora CO

8. Perelman School of Medicine University of Pennsylvania Philadelphia PA

9. Health Canada Ottawa Ontario Canada

10. Actelion Pharmaceuticals Ltd Allscwil Switzerland

11. Childrens Memorial Health Institute Warsaw Poland

12. Department of Paediatric Cardiology Paediatric Heart Center Lund University and Skåne University Hospital Lund Sweden

13. MSD Lucerne Switzerland

14. Medicines Evaluation Board Utrecht the Netherlands

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Reference49 articles.

1. Paediatric drug use with focus on off‐label prescriptions at Swedish hospitals – a nationwide study

2. Off-Label Use of Drugs in Children

3. Pediatric Information in Drug Product Labeling

4. European Medicines Agency . Paroxetine. Resource [internet] EMA website 2004. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Paroxetine/human_referral_000131.jsp. Accessed February 14 2019.

5. Steps towards harmonization for clinical development of medicines in pediatric ulcerative colitis‐a global scientific discussion part 1: efficacy endpoints and disease outcome assessments;Sun H;J Pediatr Gastroenterol Nutr,2014

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