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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is a recording from September 2022
Regulations in the US and Europe require and/or incentivize sponsors to evaluate their drugs (small molecules and biologics) for use in appropriate pediatric populations. It is generally agreed that that these regulations have stimulated new research efforts in pediatrics. It is essential that individuals, involved in global pharmaceutical research and development, are familiar with these regulations in order to create development efficiencies and minimized product development delays and cost.
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development. They will discuss intrinsic challenges with generating data across pediatric populations and provide case studies on how model-informed drug development (MIDD), can achieve a more efficient and more predictive clinical research process. Finally, our experts will share with you how to effectively communicate the plan to regulatory authorities.
Lynne Georgopoulos, RN, MSHS, RAC
Lynne has over 30 years of biopharmaceutical and CRO experience providing strategic, clinical development and regulatory advice at all stages of product development. She has spent the last several years promoting innovative methods to accelerate pediatric drug development as VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm. She has led numerous successful regulatory filings and agency interactions (e.g., Pre-IND, INDs, NDA/BLAs, EMA scientific advice, EOP2, and Pre-NDA).
S.Y. Amy Cheung, PhD
S. Y. Amy Cheung is Senior Director of Integrated Drug Development. Dr. Cheung has over a decade of experience working in the pharmaceutical industry at AstraZeneca (AZ), with her role as Senior Pharmacometrician and Project manager of AZ Paediatric working group. She obtained her Ph.D. from the University of Manchester, on the topic of Structural Identifiability Analysis in Pharmacokinetic and Pharmacodynamic Models. After receiving her Ph.D. she worked as a postdoc on mechanistic modeling at the Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester.
She was the co-lead for the cardiac safety training for the IMI DDmoRe project and is also an active member of the EFPIA Model Informed Drug Discovery and Development (MID3) workgroup. She was a chair of IQ Consortium Clinical Pharmacology Leadership Group Pediatric Working Group in 2018 and current co-chair of IQ Consortium TALG, CPLQ PBPK Pediatric group.
Jacqui is an Associate Principal Regulatory Writer in the Regulatory Services group at Certara. Jacquelyn has over 20 years combined experience in the pharmaceutical industry, clinical diagnostic care and research, and medical writing. In her current role, she routinely provides guidance on regulatory strategy and clinical development across all stages of drug development and has led many successful regulatory submissions in the US and Europe across a variety of therapeutic areas. In addition, Jacquelyn has held positions in drug discovery and development at Merck and Co., Inc., as well as in a clinical setting at the Children’s Hospital of Philadelphia and the Hospital of the University of Pennsylvania. Jacquelyn received degrees neuroscience and psychology from Cedar Crest College.
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