Regulatory Requirements for Excipients used in Drugs for the China Market

Wednesday, May 20, 2020 - 9:00am

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This webinar would focus 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 the 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

Learning objectives for this webinar include:
1. Understanding of evolution 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 concerns

 

Presenter(s)

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
Dupont Nutrition and Biosciences

Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.

Ms. Zawislak Priscilla has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products.  She is IPEC-Americas Immediate Past-Chair and is the current President of the IPEC Federation.  Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business.  Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).

Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee.  She is also President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org