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  4. Regulatory Education for Industry (REdI): Generic Drugs Forum April 15 & 16, 2020 - 04/15/2020 - 04/16/2020
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Event Title
Regulatory Education for Industry (REdI): Generic Drugs Forum April 15 & 16, 2020
April 15 - 16, 2020


Date:
April 15 - 16, 2020
Time:
8:00 AM - 4:00 PM ET
Speaker(s):
Sally Choe, Ph.D.
Leadership Role
Director - Office of Generic Drugs

Michael Kopcha, Ph.D., R.Ph.
Leadership Role
Director - Office of Pharmaceutical Quality

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Recordings Speaker
Keynote from Office of Generic Drugs (OGD) Sally Choe
Director
Office of Generic Drugs (OGD)
Keynote from the Office of Pharmaceutical Quality (OPQ) Michael Kopcha
Director
Office of Pharmaceutical Quality (OPQ)
Product Specific Guidances (PSGs) Dave Coppersmith
Regulatory Counsel
Office of Generic Drug Policy (OGDP) | OGD
 
Myong-Jin Kim
Deputy Director
Division of Quantitative Methods and Modeling (DQMM)
Office of Research and Standards (ORS)
OGD
Generic Drug Labeling: Recommendations for High-Quality Submissions Rachel Goehe
Director
Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
OGD
 
Katherine Won
CDR | USPHS
Deputy Director
DLR | ORO | OGD
New Programs and Requirements Under FDARA
 
Competitive Generic Therapies (CGT)
 
Post-Approval Notice Requirements
Jonathan Hughes
Regulatory Counsel
OGDP | OGD
 
Rinku Patel
LCDR | USPHS
Acting Team Leader
Patent and Exclusivity Team
Division of Legal and Regulatory Support (DLRS)
OGDP | OGD
 
Andrew Coogan
LCDR, USPHS
Regulatory Review Officer
DLRS |OGDP |OGD
Pre-ANDA Interactions with the FDA Kris Andre Associate Director for Regulatory Affairs ORS | OGD | CDER
How to meet FDA’s Requirement for Electronic Submission of an ANDA Application
and Study Data
 
Electronic Submissions Update
 
Study Data Technical Rejection Criteria
Jonathan Resnick Cloud Collaboration Capability Team Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI) Office of Strategic Programs (OSP) | CDER
 
Heather Crandall Cloud Collaboration Capability Team DDMSS | OBI | OSP
ANDA Program Performance Review and Tips Ted Sherwood
Director
ORO | OGD
Application Case Studies on FDA’s Action Letter Timing Gwendolyn Murphy
Dara Nardini
Sarah Nguyen
Warren Simmons
Parth Soni
Dustin Derosales
The Importance of Generic Drug Pharmacovigilance Linda Forsyth
Medical Officer
CSSS | OGD
 
Edward Kim
Epidemiologist
CSSS | OGD
 
Debbie Catterson
Lead Clinical Safety Coordinator
CSSS | OGD
Current Global Generic Drug Landscape Moderator: Iilun C. Murphy
Deputy Director
Clinical and Regulatory Affairs | OGD
 
Amanda Roache
Operations Research Analyst
Office of the Center Director (OCD) | CDER
 
Lei Zhang
Deputy Director
ORS | OGD
 
Mark Abdoo
Associate Commissioner
Global Policy & Strategy
 
Raphael Brykman
Consumer Safety Officer
ICH Q12 Guidance and Emerging Technology Program
 
ICH Q12 as it Applies to Generic Drugs
 
Fostering Innovation through Collaboration
Ashley Boam
Director of Policy
Office of Policy for Pharmaceutical Quality (OPPQ)
OPQ
Thomas O’Connor
Chemist
Division of Product Quality Research (DPQR)
Office of Testing and Research (OTR)
OPQ
Common CMC (Quality) Issues and How to Avoid Them, Part One
 
Common Drug Product Quality Issues and How to Mitigate
or Avoid Them
 
Common CMC Issues for Manufacturing Process and Facility Reviews
Simin Hassannejad Tabasi Product Quality Assessor Division of Modified and Immediate Release Products 1 OPQ
 
Pei-I Chu Branch Chief Division of Pharmaceutical Manufacturing Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ
Common CMC (Quality) Issues and How to Avoid Them, Part Two
 
Emerging Topics and Trends in Recent Inspections and How They Can Affect Application Approval
 
Facility Submission Expectations in View of the 356H Form
Tsedenia Woldehanna
Consumer Safety Officer
Office of Pharmaceutical Surveillance (OPS
OPQ
 
Rose Xu
Quality Assessment Lead (Acting)
Division of Pharmaceutical Manufacturing IV
OPMA | OPQ
Generic Combination Products
 
 
Combination Product Assessment for ANDAs
 
Regulatory Update on Generic Combination Products
Ashish Rastogi Quality Assessment Lead (Acting) Branch III Division of Liquid Based Products – 1 Office of Lifecycle Drug Products (OLDP) OPQ
 
Steven Hertz Consumer Safety Officer Division of Pharmaceutical Manufacturing IV OPMA | OPQ
Facility Readiness and Related Issues
 
 
Applying GMPs to the Quality Assessment of the Applications
 
Compliance Trends and Guidance while Engaging Manufacturers
Aditi Thakur
Chemist
Product Quality Assessor
Division of Pharmaceutical Manufacturing III
OPMA | OPQ
 
Tara Gooen Bizjak
Regulatory Officer
CDR | USPHS
Office of Manufacturing Quality (OMQ)
Office of Compliance (OC)

About This Event

This two-day virtual forum offers you the opportunity to interact with FDA subject matter experts from every part of the generic drug review program. The goal of the forum is to provide information to help applicants achieve success in the development of generic drug applications, known as Abbreviated New Drug Applications (ANDAs). Our presentations will offer practical advice, case studies, and discussions about scientific issues related to generic drug applications in order to assist generic drug developers with minimizing application deficiencies.

Topics

  • Competitive Generic Therapies (CGT)
  • Application Case Studies on FDA’s Action Letter Timing
  • Pre-ANDA Interactions with the FDA
  • Current Global Generic Drug Landscape Harmonizing Regulatory Science through the International Council for Harmonization (ICH)
  • Common CMC (Quality) Issues and How to Avoid Them
  • Facility Readiness and Related Issues
  • FDA’s Requirement for Electronic Submission of an ANDA Application and Study Data
  • Generic Combination Products

Who should attend?

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
  • Submit Drug Master Files (DMFs)
  • Prepare regulatory submissions