APIs & Excipients – A Global Regulatory Overview

Wednesday, September 20, 2017 - 11:00am to 1:00pm
Thursday, September 21, 2017 - 11:00am to 1:00pm

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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.

Presentation Objectives

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

What Makes this Training Unique

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.

Presenter(s)

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
The Dow Chemical Company

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.

Cancellation Policy

Must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street
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 are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

Note: 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