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.
Priscilla has been a member of IPEC Americas committees since 2001 and is the current Chair and member of the IPEC Americas Executive Committee. She is past chair of the Compendial Review Committee. Priscilla also participates in the International Food Additives Council and the Personal Care Products Council.