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

Presenter(s)

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
The Dow Chemical Company

Ms. Zawislak has over 30 years’ experience in Regulatory Affairs and Quality functions.  Currently with The Dow Chemical Company, Priscilla is the Global Regulatory Affairs Advocacy Manager for Dow’s Food, Pharma and Medical Solutions business.  Priscilla is the current Chair of IPEC-Americas and has been an active member of IPEC Americas committees since 2001 and is a member of the IPEC Americas Executive Committee.  She is also the Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India.  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.

Cancellation Policy

Note: No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Cancellations for live webinars 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.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org