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NDAs and INDs for Orally-Administered Drug Products

 
  December 05, 2017  
     
 
Netzealous LLC DBA - Compliance4All, Online
2018-02-28


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

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
 
 
Organized by: Event Manager
Invited Speakers:
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.
 
Deadline for Abstracts: 2018-02-27
 
Registration:

Full Details & Registration Link:

http://www.compliance4all.com/control/w_product/~product_id=501682LIVE?channel=molgen_Feb_2018_SEO 

E-mail: support@compliance4All.com
 
   
 
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