SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Generic Drug Forum 2019

Click for Event Details & Registration

Download the Agenda   –   Presenter Bios (Coming Soon)

Info Sheet for In-Person Attendees

ZIP of Day One Slides   –   ZIP of Day Two Slides
The above ZIP files will become available approximately 24 hours before the event begins.

Evaluation & Certificate of Attendance
The evaluation and certificate will be available on the afternoon of the second day.
They will only be available for TWO WEEKS after the event.

Day 1: April 3, 2019:

Keynote from Office of Generic Drugs (OGD)
Sally Choe
Recording Coming Soon
Keynote from the Office of Pharmaceutical Quality (OPQ)
Michael Kopcha
Recording Coming Soon
Complex Product Development
Katherine Tyner
Christine Le
Session Evaluation
Recording Coming Soon
Pre-ANDA Meeting or Controlled Correspondence?
Bhagwant Rege
Kris Andre
Session Evaluation
Recording Coming Soon
Panel Questions and Discussion
Katherine Tyner, Christine Le, Bhagwant Rege, Kris Andre
Recording Coming Soon
Mid-cycle Assessment Meetings
Andrew Kim
Session Evaluation
Recording Coming Soon
Post-complete Response Letter Meetings
Andrew Kim
Ankara (Nikki) Yokum
Evaluation included above
Recording included above
Panel Questions and Discussion
Andrew Kim, Nikki Yokum
Recording included above
Drug Master Files (DMFs) from an Abbreviated New Drug Application (ANDA) Perspective
Lauren Woodard
Hongbio Liao
Session Evaluation
Recording Coming Soon
Orange Book – Its Role in ANDAs
Alicia Chen
Session Evaluation
Recording Coming Soon
Referencing Approved Drug Products in ANDA Submissions
Susan Levine
Session Evaluation
Recording Coming Soon
505(b)(2) NDA or ANDA?
Elizabeth Friedman
Beth (Duvall) Goldstein
Session Evaluation
Recording Coming Soon
Panel Questions and Discussion
Alicia Chen, Susan Levine, Elizabeth Friedman, Beth Goldstein, Kendra Stewart
Recording Coming Soon
Practical Tips on Using the CDER NextGen Collaboration Portal
Kris Andre
Session Evaluation
Recording Coming Soon
Practical Tips on eCTD
Jonathan Resnick
Session Evaluation
Recording Coming Soon
Submission of Study Data
Chao (Ethan) Chen
Session Evaluation
Recording Coming Soon
Panel Questions and Discussion
Kris Andre, Jonathan Resnick, Ethan Chen
Recording Coming Soon

Day 2: April 4, 2019:

Filing and Refuse to Receive (RTR)
Varun Vasudeva
Phuong (Aiden) Nguyen
Session Evaluation
Recording Coming Soon
Assessment Tips
Dat Doan
Session Evaluation
Recording Coming Soon
Bioequivalence Case Studies
Ke Ren
Session Evaluation
Recording Coming Soon
Panel Questions and Discussion
Aiden Nguyen, Varun Vasudeva, Dat Doan, Ke Ren, Julia Lee
Recording Coming Soon
Stability Case Studies
Nusrat (Nusie) Motlekar
Frank Holcombe, Jr.
Session Evaluation
Recording Coming Soon
Dissolution Case Studies
Paul Seo
Session Evaluation
Recording Coming Soon
Impurity Case Studies
Hongbiao Liao
Victoria Keck
Session Evaluation
Recording Coming Soon
Panel Questions and Discussion
Nusie Motlekar, Frank Holcombe, Paul Seo, Hongbio Liao, Victoria Keck
Recording Coming Soon
Types of Fees
Donal Parks
Session Evaluation
Recording Coming Soon
Continuous Manufacturing with a Generic Perspective
Sau (Larry) Lee
Session Evaluation
Recording Coming Soon
Manufacturing Process and Controls: How to Avoid Major Assessment Issues Turning into Potential Deficiencies/Approvability Issue
Yaodong (Tony) Huang
Session Evaluation
Recording Coming Soon
Deficiencies and Observations from Facility Evaluations and Inspections
Vidya Pai
Session Evaluation
Recording Coming Soon
Panel Questions and Discussion
Larry Lee, Tony Huang, Vidya Pai
Recording Coming Soon