Regulatory Requirements for Excipients Used in Drugs for the China Market

Wednesday, September 4, 2019 - 11:00am

This webinar will 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)

Dave R. Schoneker

Dave headshot
Global Regulatory Director - Strategic Relationships
Colorcon

David R. Schoneker is the Global Regulatory Director for Strategic Relationships at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets. He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University.  His previous position at Colorcon was Director of Quality Assurance and Quality Control.  He has been at Colorcon since 1977.  Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum.  He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). 

Mr. Schoneker is currently the President-Elect of IACM and will become President of IACM in January 2019.  In this role he will coordinate IACM’s international regulatory activities related to Synthetic and Natural colorants for use in foods and drugs and will participate as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA).

Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee.  He is now serving as the Vice Chair for Science and Regulatory Policy where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security.  Mr. Schoneker also Co-Chairs IPEC’s QbD/Product Development Committee, Composition Committee and IID Working Group.  He also is a member of the Board of Directors of the IPEC Foundation.  He is the Global Expansion Coordinator for the IPEC Federation and has been critically involved in the development of many of the IPEC groups and Partnerships around the world.

He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization.  He previously was the USP Liaison for IPEC-Americas and represented them as a member of the United States Pharmacopeial Convention for many years.  Mr. Schoneker previously coordinated International Harmonization efforts for IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients.  He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification and the appropriate use of certificates of analysis.  Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients and has been chairing the Coalition for Rational Implementation of the Elemental Impurity Requirements since 2010.

Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 4th edition of the Enclyclopedia of Pharmaceutical Technology which was published in 2013.  He has also authored many other excipient quality and safety related papers in various journals and trade magazines.

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