Webcast | Virtual

Event Title

Generic Drugs Forum 2022: The Current State of Generic Drugs

April 26 - 27, 2022

Date:: April 26 - 27, 2022
Day1:: Tue, Apr 26 8:15 AM - 4:00 PM ET
Day2:: Wed, Apr 27 8:30 AM - 4:00 PM ET

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KEYNOTE SPEAKERS

Janet Woodcock, M.D.
Principal Deputy Commissioner - Office Of The Commissioner
U.S. Food and Drug Administration (FDA)

Sally Choe, Ph.D.
Director
Office of Generic Drugs (OGD) | CDER | FDA

Michael Kopcha, Ph.D., R.Ph.
Director
Office of Pharmaceutical Quality (OPQ) | CDER | FDA

ABOUT THIS EVENT

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice, presenting case studies, and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

This year’s theme is The Current State of Generic Drugs and presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs.

TOPICS COVERED

Data Integrity
Facility Evaluation
FDA’s Pre-ANDA Program
Global Generic Drugs
Knowledge-Aided Assessment and Structured Application (KASA)
Overview of ANDA Program Statistics
Pharmaceutical Quality Systems
Post-Market Safety and Surveillance of Generic Drugs
Product-Specific Guidances for Generic Drug Development
Technical Considerations for Pharmaceutical Product Lifecycle Management

INTENDED AUDIENCE

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

plan to submit an ANDA, are in the process of submitting an ANDA or have submitted an ANDA
involved in generic drug development
work on generic drug bioequivalence, facility evaluation, stability, dissolution and impurity testing

FDA RESOURCES

Product-Specific Guidances for Generic Drug Development
Pharmaceutical Quality Resources
Industry Resources
Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
Federal Register Notices Related to Generic Drugs
Generic Drug User Fee Amendments (GDUFA) Science and Research

Topics & Presentations	Speakers
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 1, Session 1
Keynote	Janet Woodcock Principal Deputy Commissioner Office of the Commissioner U.S. Food and Drug Administration
Office of Generic Drugs Keynote	Sally Choe Director Office of Generic Drugs (OGD) \| CDER
Office of Pharmaceutical Quality Keynote	Michael Kopcha Director Office of Pharmaceutical Quality (OPQ) \| CDER
Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Assessment	Peter Capella Director Division of Immediate and Modified Release Products II (DIMRPII) Office of Life Cycle Products (OLDP) \| OPQ \| CDER
Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Manufacturing Assessment	Rakhi Shah Associate Director Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ \| CDER
Use of Knowledge-Aided Assessment and Structured Application (KASA) in Biopharmaceutics Assessment	Kimberly Raines Branch Chief Division of Biopharmaceutics Office of New Drug Products (ONDP), OPQ \| CDER
Integrated Drug Product Assessment: Expectations	Mayra Pineiro Sanchez Senior Pharmaceutical Quality Assessor Division of Immediate and Modified Release Products II OLDP \| OPQ \| CDER
Questions & Panel Discussion	All speakers
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 1, Session 2
ANDA Program Annual Public Stats and What they Mean: Office of Generic Drugs (OGD)	Iilun Murphy Deputy Director Clinical & Regulatory Affairs OGD \| CDER
Program Annual Public Stats and What they Mean: Office of Regulatory Operations (ORO)	Robert Berger Analytics Team David Holovac Analytics Team Russell Storms Associate Director for Analytics Edward (Ted) Sherwood Director Office of Regulatory Operations (ORO) OGD \| CDER
ANDA Program Annual Public Stats and What they Mean: Office of Generic Drug Policy (OGDP)	Andrew Coogan LCDR, USPHS Division of Legal and Regulatory Support (DLRS) OGDP \| CDER
ANDA Program Annual Public Stats and What they Mean: Office of Lifecycle Drug Products (OLDP)	Derek Smith Deputy Director OPMA \| OPQ \| CDER
Questions & Panel Discussion	Iilun Murphy, Edward Sherwood, Andrew Coogan, Derek Smith and Geoffrey Wu
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 1, Session 3
Culture of Quality	Nilufer Tampal Associate Director for Scientific Quality Immediate Office \| Office of Bioequivalence (OB) \| OGD \| CDER Shujun Chen Senior Pharmaceutical Quality Assessor Division of Pharmaceutical Manufacturing II (DPMII) OPMA \| OPQ \| CDER
Data Integrity in ANDA Submissions	Minglei Cui CDR, USPHS Team Leader, Division of Bioequivalence II (DBII) OB \| OGD \| CDER
Data Integrity Issues from BA/BE Clinical Site Inspections: Case Studies and OSIS Evaluation	Cynthia (Yiyue) Zhang Senior Staff Fellow Division of New Drug Study Integrity (DNDSI) Office of Study Integrity and Surveillance Session (OSIS) Office of Translational Sciences (OTS) \| CDER
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 1, Session 4
Analytical Data Integrity: Looking Beyond the Obvious	Kara Scheibner Pharmacologist Division of Generic Drug Study Integrity (DGDSI) OSIS \| OTS \| CDER
Data Integrity in Pharmacology/Toxicology Studies	Victoria Keck Team Leader Division of Pharmacology/Toxicology Review (DPTR) Office of Safety and Clinical Evaluation (OSCE) OGD \| CDER
Role of Data Integrity in Drug Applications	Byeongtaek Oh Staff Fellow Division of Pharmaceutical Manufacturing I (DPMI) OPMA \| OPQ \| CDER
Data Integrity Q&A and Panel Session	Nilufer Tampal, Shujun Chen, Minglei Cui, Cynthia Zhang, Kara Scheibner, Victoria Keck, Byeongtaek Oh, and Partha Roy Director OB \| OGD \| CDER Dave Coppersmith Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD \| CDER
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 2, Session 1
Nitrosamines in Drug Products – An Update	Andre Raw Senior Science and Policy Advisor OLDP \| OPQ \| CDER
Common Manufacturing Related Deficiencies for Liquid Products	Jinong (Jenn) Li Chemist OPMA \| OPQ \| CDER
Questions & Panel Discussion	Andre Raw and Jinong (Jenn) Li
Generic Drug Development and Globally Divergent Regulations	Sarah Ibrahim Associate Director for Global Generic Drug Affairs OGD \| CDER
Overview of the Product-Specific Guidance (PSG) Program	Karen Bengtson Lead Regulatory Health Project Manager ORS \| OGD \| CDER
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 2, Session 2
Approaches Using Proactive Research in Support of Product Specific Guidance (PSG) Development	Darby Kozak Deputy Director Division of Therapeutic Performance I (DTP I) ORS \| OGD \| CDER Xiaoming Xu Branch Chief Office of Testing and Research (OTR) OPQ \| CDER
Questions & Panel Discussion	Sarah Ibrahim, Karen Bengtson, Xiaoming Xu, Darby Kozak and Lei Zhang Deputy Director ORS \| OGD \| CDER
Review of Bio-INDs in the Office of Generic Drugs	Michael Spagnola Clinical Team Leader Division of Clinical Safety and Surveillance (DCSS)
Overview of Pre-ANDA Meetings	Susan Hakeem Regulatory Health Project Manager ORS \| OGD \| CDER
Questions & Panel Discussion	Michael Spagnola, Susan Hakeem, Karen Bengtson
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 2, Session 3
Best Practices and Strategies for Communication with FDA	Robert Gaines Deputy Director Office of Program and Regulatory Operations (OPRO) OPQ \| CDER Warren Simmons LT, USPHS Regulatory Project Manager ORP \| OGD \| CDER
Division of Filing Review: Best Practices for ANDA and Controlled Correspondence Submissions	Peter Enos Filing Reviewer, Division of Filing Review (DFR) ORO \| OGD \| CDER Elizabeth Kim LCDR, USPHS Controls Coordinator, DFR ORO \| OGD \| CDER
Question & Panel Discussion	Robert Gaines, Warren Simmons, Peter Enos, Elizabeth Kim, and Julia Lee Deputy Director DFR \| ORO \| OGD \| CDER
Project Management of Premarket and Postmarket Generic Drug Safety	Tu-Van Lambert Senior Regulatory Health Project Manager Division of Clinical Safety and Surveillance OSCE \| OGD \| CDER
Best Practices for Conducting Comparative Analyses in ANDAs	Andrew Fine CDR, USPHS Senior Advisor Division of Clinical Review (DCR) OSCE \| OGD \| CDER
Questions & Panel Discussion	Tu-Van Lambert, Andrew Fine
Generic Drugs Forum 2022: The Current State of Generic Drugs, Day 2, Session 4
Use of Alternate Tools for Inspections During the COVID-19 Pandemic	Haitao Li Branch Chief OPMA \| OPQ \| CDER Alexander Gontcharov Staff Fellow OPMA \| OPQ \| CDER
Office of Quality Surveillance (OQS) and the Assessment of Pharmaceutical Quality Systems (PQS) in support of ICH Q12	Alex Viehmann Division Director Division of Quality Intelligence II Office of Quality Surveillance (OQS) OPQ \| CDER
OPQ Policy Update – Guidance ICH Q12 Technical Considerations for Pharmaceutical Product Lifecycle Management	Ashley Boam Director Office of Policy for Pharmaceutical Quality (OPPQ) OPQ \| CDER
Questions & Panel Discussion	Alexander Gontcharov, Haitao Li, Alex Viehmann, Ashley Boam