Forum | Mixed

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 a.m. - 4:00 p.m. ET

Speaker(s):: Michael Kopcha,, Ph.D., R.Ph.

Leadership Role

Director - Office of Pharmaceutical Quality

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