Webinar - Novel Excipient Review Pilot Program Overview and Q&A

Category: Other
  • IPEC-Americas - 3138 10th Street N. Suite 500 - Arlington, VA 22201 - United States
  • 27 Oct 2021

Dates:  Wednesday, October 27, 2021 - 17:00 CEST - 11:00 EDT

Join us for an overview of the Novel Excipient Review Pilot Program followed by Q&A.

The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. This Pilot Program will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients. (Source)

Audience
Roles

  • Research & Development
  • Quality
  • Regulatory
  • Formulations

Industry Segments

  • Pharmaceutical - Originator Drugs
  • Biologics - Biotech Drugs (Originators)
  • Medical Device / Combination Products
  • Consumer Goods (Medical Products)

 

Presenters

Susan Zuk, MS, Branch Chief, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA

Ashutosh Rao, Ph.D., Chief, Laboratory of Applied Biochemistry, Supervisory Pharmacologist, SBRBPAS Expert, Office of Biotechnology Products OPQ, CDER, FDA

Robeena M. Aziz, Senior Toxicologist, Office of New Drugs, FDA

Registration Fees
IPEC-Americas Members: 89$
IPEC-Americas Non Members: 179$

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Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

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

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

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org