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  4. Generic Drugs Forum 2021: Lifecycle of a Generic Drug - 04/28/2021
  1. News & Events for Human Drugs

Forum | Virtual

Event Title
Generic Drugs Forum 2021: Lifecycle of a Generic Drug
April 28 - 29, 2021

Scheduled
Date:
April 28 - 29, 2021

 

Presentation Title

Presenter(s)

Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)

Sally Choe
Director
Office of Generic Drugs (OGD)
CDER

Office of Pharmaceutical Quality (OPQ) Update

Sau (Larry) Lee
Deputy Director of Science
Office of Pharmaceutical Quality (OPQ) | CDER

Global Generic Drug Landscape

Sarah Ibrahim
Associate Director of Global Generic Drug Affairs
OGD | CDER

Data Integrity Issues in Bioequivalence Studies

Nilufer Tampal
Acting Deputy Director
Office of Bioequivalence (OB)
OGD | CDER

Bioavailability/Bioequivalence Site Evaluation During the Pandemic

Makini Cobourne-Duval
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
CDER

Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs

Victoria Keck
Division of Clinical Review
OGD | CDER

Panel Discussion

Sarah Ibrahim, Nilufer Tampal,
Makini Cobourne-Duval, Victoria Keck

OPQ Policy Update

Ashley Boam
Office of Policy for Pharmaceutical Quality (OPPQ)
OPQ | CDER

Update on CDER’s Quality Management Maturity Program

Jennifer Maguire
Office of Quality Surveillance (OQS)
OPQ | CDER

Panel Discussion

Ashley Boam, Jennifer Maguire

Pre-ANDA Program

Caliope Sarago
Office of Research and Standards (ORS)
OGD | CDER

Pre-ANDA Program Update and Tips for Success – OPQ Perspective

Fang Yuan
Office of Lifecycle Drug Products (OLDP)
OPQ | CDER

Controlled Correspondence Related to Pharmaceutical Quality

Janice T. Brown
Chief, Policy Development and Evaluation Branch
Division of Internal Policies and Programs (DIPAP)
OPPQ | OPQ | CDER

Panel Discussion

Caliope Sarago, Fang Yuan,
Janice T. Brown and Lei Zhang

Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence

Nnenna Nzelibe
Bijal Patel
Division of Filing Review (DFR)
Office of Regulatory Operations (ORO)
OGD | CDER

ANDA Labeling: Recommendations and Helpful Resources

Charlene Peterson
Esther Chuh
CDR, USPHS
Division of Labeling Review (DLR)
ORO | OGD | CDER

Panel Discussion

Nnenna Nzelibe, Bijal Patel,
Charlene Peterson, Esther Chuh,
and Julia Lee

Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach

Tao Bai
OB | OGD | CDER

Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections

Cassie Abellard
Jonathan Swoboda
Division of Microbiology Assessment
Office of Pharmaceutical Manufacturing
Assessment (OPMA)
OPQ | CDER

Panel Discussion

Tao Bai, Cassie Abellared,
Jonathan Swoboda

Mid-Review Cycle Meeting Overview

Lakeeta Carr
CAPT, USPHS
Nicholas Daniel
LCDR, USPHS
Division of Project Management (DPM)
ORO | OGD | CDER

Information to Include with Cover Letters

Cassandra Metu
LCDR, USPHS
DMP | ORO | OGD | CDER

Application Communications – Quality Assessment Perspective

Heidi Lee
Office of Program and Regulatory Operations (OPRO)
OPQ | CDER

Panel Discussion

Lakeeta Carr, Nicholas Daniel,
Cassandra Metu, Heidi Lee

Fostering Innovation Through OPQ’s Emerging Technology Program

Tom O'Connor
Office of Testing and Research (OTR)
OPQ | CDER

Lab Science to Support Generic Complex Drug Product Assessment

Rachel Dunn
OTR | OPQ | CDER

Assessment of Extractables/Leachables Data in ANDA Submissions

Patricia Onyimba
OLPD | OPQ | CDER
Kshitij (Kris) Patkar
OPMA | OPQ | CDER

Panel Discussion

Tom O'Connor, Changning Guo, Patricia Onyimba, Shin
(Grace) Chou, Kris Patkar, and Melanie Mueller

Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms

Min Li
Division of Biopharmaceutics
ONDP | OPQ | CDER

Integrated Manufacturing Assessment: Expectations

Vidya Pai
OPMA | OPQ | CDER

Building a Better Sterility Assurance Application

Marla Stevens-Riley
OPMA | OPQ | CDER

Panel Discussion

Min Li, Vidya Pai, Marla Stevens-Riley,
and Mayra Pineiro-Sanchez

Postmarketing Safety and Surveillance of Generic Drugs Update

Howard Chazin
Clinical Safety and Surveillance Staff
OGD | CDER

Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies

Linda Forsyth
Clinical Safety and Surveillance Staff
OGD | CDER

Update on Shared System REMS for Generic Drugs

Lauren Gilles
REMS Team
OB | OGD | CDER

ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues

Niles Ron
OLDP | OPQ | CDER

Panel Discussion

Howard Chazin, Linda Forsyth, Lauren Gilles,
Niles Ron, and Debra Catterson

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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.

INTENDED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

  • plan to submit an ANDA or are in the process of submitting an ANDA
  • involved in generic drug development
  • work on bioequivalence, stability, dissolution and impurity testing
  • prepare regulatory submissions

FDA RESOURCES

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