Generic Drugs Forum 2021:
Lifecycle of a Generic Drug
April 28 & 29, 2021
This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) review process. Presentations will focus on various aspects from pre-ANDA, drug development, post-marketing and global generic drug affairs program support for the generic drug program.
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The agenda may be updated as changes are made. The link above is to the latest version, Version 8, updated on April 24, 2021. |
The speaker biographies document provides detailed information of each of the Forum speakers. |
Session Recordings:
Day One:
- Office of Generic Drugs (OGD) Keynote – Sally Choe
- Office of Pharmaceutical Quality (OPQ) Keynote – Sau (Larry) Lee
- Global Generic Drug Landscape – Sarah Ibrahim
- Data Integrity Issues in Bioequivalence Studies – Nilufer Tampal
- Bioavailability/Bioequivalence Site Evaluation During the Pandemic – Makini Cobourne-Duval
- Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs – Victoria Keck
- Questions & Panel Discussion
- OPQ Policy Update – Ashley Boam
- Update on CDER’s Quality Management Maturity Program – Jennifer Maguire
- Questions & Panel Discussion
- Pre-ANDA Program – Caliope Sarago
- Pre-ANDA Program Update and Tips for Success – OPQ Perspective – Fang Yuan
- Controlled Correspondence Related to Pharmaceutical Quality – Janice T. Brown
- Questions & Panel Discussion
- Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence – NNnenna Nzelibe and Bijal Patel/li>
- ANDA Labeling: Recommendations and Helpful Resources – Charlene Peterson and Esther Chuh
- Questions & Panel Discussion
- Addressing Common Challenges in Bioequivalence Studies Due to COVID-19: OGD’s Approach for Timeliness, Clarity, and Consistency – Tao Bai
- Learnings and Insight from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections – Cassie Abellard and Jonathan Swoboda
- Questions & Panel Discussion
Day Two:
- Mid-Review Cycle Meeting Overview – Lakeeta Carr and Nicholas Daniel
- Information to Include with Cover Letters – Cassandra Metu
- Application Communications – Quality Assessment Perspective – Heidi Lee
- Questions & Panel Discussion
- Fostering Innovation Through OPQ’s Emerging Technology Program – Tom O’Connor
- Lab Science to Support Generic Complex Drug Product Assessment – Rachel Dunn
- Assessment of Extractables/Leachables Data in ANDA Submissions – Patricia Onyimba and Kshitij (Kris) Patkar
- Questions & Panel Discussion
- Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms – Min Li
- Integrated Manufacturing Assessment: Expectations – Vidya Pai
- Building a Better Sterility Assurance Application – Marla Stevens-Riley
- Questions & Panel Discussion
- Postmarketing Safety and Surveillance of Generic Drugs Update – Howard Chazin
- Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies – Linda Forsyth
- Update on Shared System REMS for Generic Drugs – Lauren Gilles
- ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues – Niles Ron
- Questions & Panel Discussion
Questions?
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More Information
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