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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