Atypical actives

Wednesday, April 13, 2016 - 11:00am to 1:00pm

By definition, an Atypical Active is an “excipient, food additive or personal care ingredient” that is being used as an “active ingredient” in a formulation. In some cases it is the only ingredient. Emerging regulatory initiatives are changing the way these materials have historically been handled, e.g. FDASIA and EU's Falsified Medicines Directive.

Presentation Objectives

Key Topics:

  • New regulatory implications
  • What are appropriate GMPs to use for Atypical Actives
  • If Regulators apply ICH Q7 API GMPs to manufacture of “Atypical Actives” what could happen?
  • Potential Strategy for Next Steps
  • Proposed Solutions


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

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.

Please contact IPEC-Americas Training Coordinator
571-814-3450 or email