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FDA 505(b)(2) Applications Seminar
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Regis Technologies invites you for a seminar on FDA 505(b)(2) applications. Two guest speakers from PAREXEL Consulting, Dr. Aloka Srinivasan and Dr. Partha Roy, will deliver the two part seminar. Read their abstracts below for more details. A light breakfast will be served.

3/4/2016
When: Friday, March 4, 2016
8 - 9:30 a.m.
Where: 8210 Austin Ave
Morton Grove, Illinois  60053
United States
Contact: Kristine Biederer
847-583-7675

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Regis Technologies invites you for a seminar on FDA 505(b)(2) applications.
 
Two guest speakers from PAREXEL Consulting, Dr. Aloka Srinivasan and Dr. Partha Roy, will deliver the two part seminar.
 
Read their abstracts below for more details. For more information, click HERE.
 
Join us for coffee and chemistry on Friday, March 4th, 8-9:30AM.
 
Coffee and a light breakfast served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
 
"Regulatory Pathway Considerations for 505(b)(2) Applications at FDA" Aloka Srinivasan, Ph.D., Principal Consultant, PAREXEL Consulting
 
This presentation will highlight the following: Regulatory Pathway – Where does a 505(b)(2) fit? Objectives of 505(b)(2) applications Critical questions related 505(b)(2) submissions The thin line between 505(b)(2) and 505(j) "All 505(b)(2)s are not created equal." Partha Roy, Ph.D., Director, PAREXEL Consulting This presentation will highlight the following: Key distinguishing features across 505 applications: b1, b2 and j Definition of a 505(b)(2) Application Objectives of 505(b)(2) Pathway Type of Information to Reference 505(b)(2) Q&A and recent examples/case studies

 


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