This webinar focused on current and emerging CFDA regulatory activities in China related to the use and approval of excipients, including but not limited to:
1) Evolution of excipient regulations in China
2) Recent changes in government structure and developments concerning registration requirements
3) Challenges for global drug companies concerning the Chinese Pharmacopeia (ChP).
Learning objectives for this webinar include:
1. Understanding the evolution of regulatory requirements from bundling review, to registration, to joint review of excipients used in drug products
2. Overview for the China pharmaceutical regulatory bodies reform in 2018
3. Concerns for current registration document requirements
4. Review of current and future ChP priorities
Priscilla Zawislak – Vice President, IPEC Federation, Immediate Past-Chair, IPEC-Americas
Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products. Currently with IFF (International Flavors & Fragrances, formerly DuPont Nutrition & Biosciences), she is the Global Regulatory Affairs Advocacy Manager for the pharmaceutical business and is responsible for regulatory advocacy for excipients, APIs and food additives. Prior positions included Global Regulatory Affairs Manager for Ashland Specialty Ingredients Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products, and Quality Manager at FMC Health and Nutrition (which is now part of IFF).
Priscilla is currently Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, China, Japan and India. She is also the Immediate Past Chair of IPEC-Americas, has been an active member of IPEC-Americas committees since 2001, is a member of the IPEC Americas Executive Committee and a member of the Board of Directors of EXCiPACT®. She has been a member of several USP project teams and is a delegate to the USP Convention.
Priscilla earned her degrees in Biological Sciences and Chemistry from the University of Delaware.