What are the current pediatric requirements and incentives for new products in four major markets: US, Europe, Japan, and China?

• In the US, PREA requires the submission of a Pediatric Study Plan (PSP) and BPCA provides for certain incentives for pediatric drug development. Under FDARA 2017, oncology products with orphan drug designation are no longer exempt from PREA. How will FDA implement the Molecular Targets List?
• In EU, Regulation No. 1901/2006 requires the submission of a Pediatric Investigation Plan (PIP) and provides for certain incentives for pediatric drug development. EMA has recently re-assessed the impact of the pediatric requirements, following 10 years of implementation and a stakeholder workshop in March 2018. What are the findings and expected actions?
• In Japan, there is no requirement to study a new drug in pediatric patients; however, there are incentives for conducting pediatric studies. Are changes likely from PMDA?
• In China, NMPA is dramatically changing many previous regulations and requirements but pediatric studies are not required for new drugs. What new flexibilities can provide incentives for the registration of new drugs for pediatrics in China?

In addition, ICH is preparing a new guideline, ICH E11A: Pediatric Extrapolation. How is extrapolation different in pediatrics vs adults?

Participants are invited to share their recent learnings in pediatric drug development along with the speaker.

Susan Watts has more than 25 years of experience in global regulatory affairs and clinical development. She recently spent 14 years as director of regulatory affairs and global regulatory team leader at GlaxoSmithKline in product development for phases I-IV. She also has 13 years of regulatory experience in local CROs and one year of experience at a small biotechnology company.

Her regulatory focus is agency meetings, scientific advice, and major submissions for US, Europe, and Canada from pre-approval through post-approval. Her therapeutic area regulatory experience includes cardiovascular/metabolic, anti-inflammatory, immunotherapeutic, antiviral, oncology, respiratory, women's health, and neurosciences. She has developed regulatory strategies for expedited development, rare diseases, pediatrics, monoclonal antibodies, gene therapies, and combination products. Susan has a PhD in microbiology and immunology and has been RAPS US Regulatory Affairs Certified (RAC) since 1998.