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ZIP of Day One Slides   –   ZIP of Day Two Slides

Day 1: April 3, 2019:

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

Day 2: April 4, 2019:

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