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NDAs and INDs for Orally-Administered Drug Products

Event Details

NDAs and INDs for Orally-Administered Drug Products

Time: February 28, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: online
Organized By: Adam Fleaming
Latest Activity: Dec 5, 2017

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Event Description

Overview:
This webinar will be helpful to applicants conducting BA/BE studies
during the IND period, also FDA guidance recommendations on how to
meet the BA and BE requirements in 21 CFR 320 as they apply to oral
dosage forms.

Why should you Attend:
Understanding when Bioavailability and Bioequivalence studies should
be done can help attendees avoid having to re-do clinical trials, help to
determine dosage regimen that achieves target drug exposure.

Areas Covered in the Session:

Review definitions necessary for understanding bioavailability and
bioequivalence
Review of FDA guidance recommendations on how to meet the BA and
BE requirements in 21 CFR 320 as they apply to oral dosage forms.
This webinar will be helpful to applicants conducting BA/BE studies
during the IND period.

Who Will Benefit:
Regulatory Managers
Specialists
R&D
Production Personnel
Quality
Clinical Personnel
Laboratory Personnel

Speaker Profile:
Stephanie Cooke is the President/CEO of Cooke Consulting, Inc.
Stephanie uses her roughly 20 years of experience to provide global
consulting services in various areas of Regulatory Affairs, Quality
Assurance and validation for pharmaceutical, biological/biotech
products, medical device, combination drug/device and nutraceutical
firms.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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