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  4. Drug Master File (DMF) and Drug Substance Workshop - 03/03/2021
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Webcast | Virtual

Event Title
Drug Master File (DMF) and Drug Substance Workshop
March 3 - 4, 2021

Date:
March 3 - 4, 2021
Day1:
Wed, Mar 3
Day2:
Thu, Mar 4

Visit the CDER Small Business and Industry Assistance Webpage

Register and submit proposed questions for FDA discussion at the DMF and drug substance webinar on April 9, 2021 to DMFWorkshop2021@fda.hhs.gov.

Agenda Slides Review and Submit Questions on Posters

This is a Regulatory Education for Industry (REdI) conference.

 

Presentation Title

FDA Presenter

Keynote

Lawrence Yu, Ph.D.
Director Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) | CDER

Introduction to the Drug Master File (DMF) Review Process

Erin Skoda
Branch Chief (Acting) Division of Lifecycle API ONDP | OPQ | CDER

Administrative Aspects of Managing a Drug Master File (DMF)

Vathsala Selvam
Technical Information Specialist Division of Lifecycle API ONDP | OPQ | CDER

Panel Discussion

Erin Skoda, Vathsala Selvam, David Skanchy

Managing Electronic Drug Master File Submissions

Jonathan Resnick
Project Management Officer Cloud Collaboration Capability Team Division of Data Management Services and Solutions Office of Business Informatics (OBI) | CDER

Drug Master Files from a GDUFA II User Fee Perspective

Hanah Pham
Commander, USPHS
Evelyn Hong
Lieutenant Commander, USPHS Division of User Fee Management and Budget Formulation (DUFMBF) Office of Management (OM) | CDER

Timely Consult and Early Information Request (TCIR) Process for Drug Master Files (DMFs)

Jayani Perera
Chemist Division of Lifecycle API ONDP | OPQ | CDER

Effective Communication Strategies for Drug Master Files (DMF)

David Skanchy
Commander, USPHS Director, Division of Lifecycle API ONDP | OPQ | CDER
Benjamin Danso
Commander, USPHS Lead DMF Project Manager Office of Program and Regulatory Operations (OPRO) | OPQ | CDER

Panel Discussion

Jonathan Resnick, Hanah Pham, Evelyn Hong, Jayani Perera, David Skanchy, Benjamin Danso

Responses to Submitted Poster Questions

Poster Presenters

Drug Substance Facilities – Hidden and Critical Intermediate

Wei Liu
Senior Pharmaceutical Quality Assessor Division of Lifecycle API ONDP | OPQ | CDER
Cassandra Abellard
Quality Assessor/ Consumer Safety Officer Division of Pharmaceutical Manufacturing Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER

ICH Q11 Q&A - A Supporting Document for the Selection and Justification of Starting Materials

Anita Tiwari
Senior Pharmaceutical Quality Assessor Division of Lifecycle API ONDP | OPQ | CDER

Panel Discussion

Wei Liu, Cassandra Abellard, Anita Tiwari, David Skanchy

Common Issues Related to LC and GC Methods in Type II DMFs

Xinghua Wu
Chemist Division of Lifecycle API ONDP | OPQ | CDER

Process Validation and ICH Q7

David Amspacher
Chemist Division of Lifecycle API ONDP | OPQ | CDER

Regulatory Considerations in Demonstrating Complex API Sameness

Bapu R. Gaddam
Chemist Division of Lifecycle API ONDP | OPQ | CDER

Panel Discussion

Xinghua Wu, David Amspacher, Bapu R. Gaddam, David Skanchy

Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD

Hongbiao Liao
Chemist Division of Lifecycle API ONDP | OPQ | CDER

ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment

Barbara O. Scott
Chemist Division of Lifecycle API ONDP | OPQ | CDER

Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

Naomi L. Kruhlak
Scientific Lead Computational Toxicology Consultation Service (CTCS) Division of Applied Regulatory Science (DARS) Office of Translational Sciences (OTS) | CDER

Panel Discussion

Hongbiao Liao, Barbara O. Scott, Naomi L. Kruhlak

Safety Evaluation of Drug Substance Impurities in Generics

Chanchal Gupta
Pharmacology/Toxicology Reviewer Division of Clinical Review (DCR) Office of Bioequivalence (OB) Office of Generic Drugs (OGD) | CDER

Nitrosamines: Where Are We Now?

Deborah F. Johnson
Branch Chief Division of Lifecycle API ONDP | OPQ | CDER

Panel Discussion

Chanchal Gupta, Deborah F. Johnson and Sruthi King
Associate Director of Pharmacology/Toxicology Division of Clinical Review (DCR) Office of Bioequivalence (OB) | OGD | CDER

Responses to Submitted Poster Questions

Poster Presenters

API Facility Inspections

Jay Jariwala
Team Leader, Division of Drug Quality Office of Manufacturing Quality Office of Compliance | CDER

Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence

Brian Connell
Senior Pharmaceutical Quality Assessor Division of Lifecycle API ONDP | OPQ | CDER

Panel Discussion

Jay Jariwala, Brian Connell

Common CMC Issues in Type II DMFs and How to Avoid Them

Wei Liu
Senior Pharmaceutical Quality Assessor Division of Lifecycle API ONDP | OPQ | CDER

Modernizing Drug Substance Assessment through KASA

Larisa Wu
Associate Director for Science and Communications (Acting) ONDP | OPQ | CDER

Panel Discussion

Wei Liu, Larisa Wu, David Skanchy

Closing Remarks from Division of Lifecycle API

David Skanchy
Commander, USPHS
Director, Division of Lifecycle API ONDP | OPQ | CDER

 

Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principals throughout the API lifecycle.  This conference is designed to provide an update on current Agency initiatives and will cover a wide variety of topics of interest to API manufacturers and regulators.  Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, panel discussions, and Q&A for two poster sessions.  The desired outcome is to outline the various regulatory steps necessary for the successful development of a high-quality submission of drug substance information to the Agency.  

TOPICS COVERED

  • Information on submitting and managing DMFs, fee payments, and facility identification
  • How to maximize communication tools offered by the agency to get answers to your questions
  • What to consider for development of a complex API
  • Process validation and ICH Q7
  • How to select an appropriate regulatory starting material (ICH Q11 and Q11 Q&A)
  • Expectations for impurity assessment ((Q)SAR & pharm-tox) and control (ICH Q3A, Q3C, Q3D, and M7)
  • How to develop a robust chromatographic method for API release
  • Expectations for Lifecycle Management of DMFs and the Draft Post-Approval Change Guidance 
  • Common mistakes and how to avoid them-:  case study examples
  • Posters covering topics of interest

INTENDED AUDIENCE

  • Manufacturers of active pharmaceutical ingredients in support of an ANDA or NDA (AAM, APIC, PhRMA, EFPAI, JPMA, DIA)
  • Regulatory Affairs Professional or Agents 
  • Outside testing facilities that provide data to support the safety (AMES Studies, (Q)SAR predictions, nitrosamine testing to support risk assessment) or quality (release or stability testers) of the active pharmaceutical ingredient in a DMF
  • Outside manufacturing facilities that provide intermediates to be used in the manufacture of active pharmaceutical ingredients.
  • Foreign Regulatory Bodies 
  • Compendia 

FDA RESOURCES

 

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