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This webinar is intended to provide a summary of the current regulatory situation for excipients in Latin America and possible future developments. IPEC-Americas has been working with our partners in Latin America to have IPEC guidelines translated into local languages and has presented educational workshops for several years in this region to regulators and industry associations. Some countries have established regulations for excipients, e.g. ANVISA in Brazil has regulation for excipient GMPs, while other countries’ regulations do not specifically address excipients.
1) Understand regulatory requirements for excipients in various countries in Latin America.
2) Gain a perspective on how other regions operate.
3) Learn about IPEC-Americas efforts to engage and educate on best practices.
David R. Schoneker, Consultant. Dave's previous position was the Global Regulatory Director for Strategic Relationships at Colorcon, Inc. Dave is a Past Chairman of IPEC-Americas and currently serves on the Executive Committee as Vice Chair for Science and Regulatory Policy. 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 was with 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 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 the 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. He is the former President of IACM. In this role he coordinated IACM’s international regulatory activities related to synthetic and natural colorants for use in foods and drugs andticipated as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA).
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.