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/Toxiciology 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