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Seven-Part Series on Pediatric Drug Development - Part 2: Regulatory Framework US Overview

Speakers

Klaus  Rose, MD, MS

Klaus Rose, MD, MS

Chief Executive Officer, klausrose Consulting, Switzerland

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 pediatric requirements. Private interests: languages, classical guitar, cooking, wine & gardening

Melissa S. Tassinari, PhD

Melissa S. Tassinari, PhD

Former Senior Clinical Advisor, DPMH, OND, CDER, FDA , Consultant , United States

Melissa Tassinari is a Senior Clinical Advisor with the Division of Pediatric and Maternal Health (DPMH), in the Office of New Drugs at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

Christina  Bucci-Rechtweg, MD

Christina Bucci-Rechtweg, MD

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States

Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy. Her activities advancing the environment for pediatric and maternal health include: ICH E11A Expert Work Group, C-Path International Neonatal Consortium, EFGCP Children's Medicines WP, IQ Consortia Clin Pharm Leadership Group Pediatric WG & NIH/NICHD National Advisory Council on Child Health & Human Development. In her career, Christina has over 40 peer-review published articles and 100 invited lectures.

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