Wednesday, June 26 • 10:30am - 11:30am
#333: Pediatric Plans: The Challenges Between Regulations and Reality

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-666-L04-P; CME 1.00; IACET 1.00; RN 1.00

Clinical requirements children are different from adults and the strategy to implement a pediatric study has many challenges, in terms of ethical, operational, and scientific issues. Working with a uniquely vulnerable patient population provides additional complexity, with numerous regulatory requirements. The authoring of key documents to optimize pediatric drug development for regulatory approval is being integrated earlier in the drug development process. This forum features three speakers who will describe the current regulatory framework and changes in drug development in pediatric oncology, the challenges in safety reporting in pediatric clinical trials. and key documents that outline the strategy for developing a drug in pediatric patients.

Learning Objectives

Describe the key regulations governing development of trials in pediatric patients; Describe the structure and required content of a PIP and a PSP; Identify changes in oncology development for pediatric patients and opportunities for scientific collaboration; Identify challenges for accurate safety reporting in pediatric clinical trials.


Darryl Zachary L'Heureux, PhD, MPharm, MSc


Regulatory Changes in Oncology Pediatric Trials
Mark W. Kieran, DrMed, MD, PhD

Solid Planning to Optimize Patient Safety and Clinical Outcomes
Judith A. Blacklidge, BSN, MSN, RN

Key Documents For Pediatric Drug Development
Nancy Katz, PhD


Judith Blacklidge

Clinical Quality Management, ExecuPharm, Inc.
Judith Blacklidge has extensive experience in healthcare, pharmaceutical and biotechnology clinical research with roles as diversified as research CRC, CRA, CQA, team leader, program manager, safety scientist, auditor, pharmacovigilance manager, department head and director of research... Read More →
avatar for Nancy Katz

Nancy Katz

President and Principal, Medical Writing Consultant, Illyria Consulting Group, Inc.
Nancy is President of Illyria Consulting Group, Inc., which specializes in the creation of eCTD-compliant documents. As a DIA MW Community member, she chaired the E3 committee, which facilitated a Q & A to ICH E3, and the Education committee. She also serves on its extended core committee... Read More →
avatar for Mark Kieran

Mark Kieran

Clinical Trail Lead, Pediatrics Program Oncology Clinical Development, Bristol-Myers Squibb
Dr. Kieran is currently the Pediatric Clinical Trial Lead in Oncology Clinical Development, Bristol-Myers Squibb. He received his PhD in 1983 from the University of Alberta, Edmonton, Canada, and his MD in 1986 from the University of Calgary. After a post-doctoral fellowship at the... Read More →

Wednesday June 26, 2019 10:30am - 11:30am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA