Regulations for ingredients in drug products in some parts of the world are often not well known or can be confusing. Some countries do not differentiate the ingredients from the drug product (DP), while others may have regulations specific to them. This webinar will provide an overview of regulatory requirements and processes, and in some cases, the challenges they bring, for excipients and APIs in regions outside the US such as Canada, the EU, China, India, Japan, Latin America (Brazil, Argentina, Mexico), Korea and Taiwan.
After completion of this webinar you should be able to:
- Locate and identify resources (regulatory agencies, laws, regulations, guidance, etc.) within in each region/country* to define what is needed
- Describe the process of determining what applies to API, and excipients for each region / country
- Describe the process of applying learnings above to your business/company
- Describe the process of addressing questions / challenges to regulations in a region / country
*Regions/countries discussed include Argentina, Brazil, Canada, China, the EU, India, Japan, Korea, Mexico, and Taiwan
This Webinar is recommended for employees of pharmaceutical companies and excipient makers/distributors – regulatory affairs professionals and other interested parties who want to know more about the similarities and differences between APIs and excipients in regions outside the US.
Download the full program, including Learning Objectives for this course.
Accreditations/Recertifications for this Course
The Center for Professional Advancement has been approved as an Accredited Provider by the International Association for Continuing Education and Training (IACET), 11130 Sunrise Valley Drive, Suite 350, Reston, VA 20190. In obtaining this approval, The Center for Professional Advancement has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. The Center for Professional Advancement is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards. CEU will be awarded for participation in The Center for Professional Advancement’s courses at the rate of .1 CEU per contact hour. CEU will be awarded only upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment. This course offers a total of 1.5 contact hours or .2 CEUs (CEUs rounded up).
Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; Vice President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.
Ms. Priscilla Zawislak 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 Vice 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 Vice 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.
Richard G. Einig, Ph.D., RAC, CQA is a consultant specializing in the pharmaceutical and veterinary medicine industries. His experience spans over twenty years in senior management of quality, regulatory, and development units of large international companies and start-up “biotechs”. He has worked internationally with innovator and generic dosage form companies, medical device manufacturers and research organizations. Dr. Einig participated in developing the PhRMA Bulk Pharmaceutical Committee’s Guidance on Production of Drug Substance, and is an invited speaker at domestic and international meetings on quality and processing of pharmaceutical products. Dr. Einig is a member of the American Chemical Society as well as a member and carries certifications from the American Society for Quality, the Regulatory Affairs Professional Society, and the Institute for Independent Business. He received undergraduate and graduate degrees in Chemistry from St. Louis University, MBA from Webster University, and Ph.D. from Missouri University.