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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Generic Drugs Forum 2022: The Current State of Generic Drugs
April 26 - 27, 2022
Virtual

Activity Coordinator:
Forest Ford (Forest.Ford@fda.hhs.gov)
Description

Since 2013, the Generic Drugs Forum has been a way for FDA to offer practical advice, provide case studies, and take a deeper dive into the 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.

References
  • Product-Specific Guidances for Generic Drug Development https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm
  • Pharmaceutical Quality Resources https://www.fda.gov/drugs/development-approval-process-drugs/pharmaceutical-quality-resources
  • Industry Resources https://www.fda.gov/drugs/generic-drugs/industry-resources
  • Guidances Related to Generic Drugs (under topics, choose “generic drugs”) https://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch
  • Federal Register Notices Related to Generic Drugs https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=generic+drugs
  • GDUFA Science and Research https://www.fda.gov/drugs/generic-drugs/science-research
Learning Objectives
  • Describe Facility Evaluations
  • Cite FDA’s Pre-ANDA Program
  • Locate the Knowledge-Aided Assessment and Structured Application (KASA)
  • Summarize an Overview of ANDA Program Statistics
  • Identify Pharmaceutical Quality Systems
  • Outline Post-Market Safety and Surveillance of Generic Drugs
  • Locate Product-Specific Guidances for Generic Drug Development
  • Define Technical Considerations for Pharmaceutical Product Lifecycle Management
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 April 26, 2022
Time Topic Speaker
8:15 - 8:30 AM EDT Introduction and CE Remarks - Day One Forest Ford, PharmD, R. Ph
Brenda Stodart, PharmD, MS, BCGP, RAC
8:30 - 8:45 AM EDT Keynote Presentation - Principal Deputy Commissioner, FDA Janet Woodcock, MD
8:45 - 9:00 AM EDT Office of Generic Drugs (OGD) Keynote Sally Choe, PhD
9:00 - 9:15 AM EDT Office of Pharmaceutical Quality (OPQ) Keynote Michael Kopcha, PhD, R. Ph
9:15 - 9:35 AM EDT Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Assessment Peter Capella, PhD
9:35 - 9:55 AM EDT Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Manufacturing Assessment Rakhi Shah, PhD
9:55 - 10:15 AM EDT Use of Knowledge-Aided Assessment and Structured Application (KASA) in Biopharmaceutics Assessment Kimberly Raines, PhD
10:15 - 10:35 AM EDT Integrated Drug Product Assessment: Expectations Mayra Pineiro-Sanchez, PhD
10:35 - 10:55 AM EDT Questions & Panel Discussion Peter Capella, PhD
Rakhi Shah, PhD
Kimberly Raines, PhD
Mayra Pineiro-Sanchez, PhD
10:55 - 11:05 AM EDT BREAK
11:05 - 11:15 AM EDT ANDA Program Annual Public Stats and What they Mean: Office of Generic Drugs Iilun Murphy, MD
11:15 - 11:35 AM EDT ANDA Program Public Stats and What they Mean: Office of Regulatory Operations (ORO) Edward Sherwood
Russell Storms, PhD
David Holovac, RPh
11:35 - 11:45 AM EDT ANDA Program Public Stats and What they Mean: Office of Generic Drug Policy (OGDP) Andrew Coogan, PharmD
11:45 - 11:55 AM EDT ANDA Program Public Stats and What they Mean: Office of Lifecycle Drug Products (OLDP Derek Smith, PhD
11:55 - 12:15 PM EDT Questions & Panel Discussion Iilun Murphy, MD
Edward Sherwood
Andrew Coogan, PharmD
Derek Smith, PhD
Geoffrey Wu, PhD, CPH, PMP
12:15 - 12:45 PM EDT LUNCH BREAK Not offered for CE
12:45 - 1:15 PM EDT Culture of Quality Nilufer Tampal, PhD
Shujun Chen, PhD
1:15 - 1:35 PM EDT Data Integrity Issues in ANDA Submissions Minglei Cui, PhD
1:35 - 1:55 PM EDT Data Integrity Issues from BA/BE Clinical Site Inspections: Case Studies and OSIS Evaluation Yiyue Zhang, PhD
1:55 - 2:05 PM EDT BREAK
2:05 - 2:25 PM EDT Analytical Data Integrity: Looking Beyond the Obvious Kara Scheibner
2:25 - 2:45 PM EDT Data Integrity in Pharmacology/Toxicology Studies Victoria Keck, VMD, MS
2:45 - 3:05 PM EDT Role of Data Integrity in Drug Applications BYEONGTAEK OH, PhD
3:05 - 3:45 PM EDT Data Integrity Q&A and Panel Session Nilufer Tampal, PhD
Shujun Chen, PhD
Minglei Cui, PhD
Yiyue Zhang, PhD
Kara Scheibner
Victoria Keck, VMD, MS
BYEONGTAEK OH, PhD
Partha Roy, PhD
David Coppersmith, JD
3:45 - 3:55 PM EDT Day One Closing Forest Ford, PharmD, R. Ph
Not offered for CE
Day 2 April 27, 2022
Time Topic Speaker
8:30 - 8:40 AM EDT Introduction and CE Remarks - Day 2 Forest Ford, PharmD, R. Ph
Brenda Stodart, PharmD, MS, BCGP, RAC
8:40 - 9:00 AM EDT Nitrosamines in Drug Products – An Update Andre Raw, PhD
9:00 - 9:20 AM EDT Common Manufacturing Related Deficiencies for Liquid Products Jinong Jenn Li, PhD
9:20 - 9:40 AM EDT Questions & Panel Discussion Andre Raw, PhD
Jinong Jenn Li, PhD
9:40 - 10:00 AM EDT Generic Drug Development and Globally Divergent Regulations Sarah Ibrahim, PhD
10:00 - 10:20 AM EDT Overview of the Product-Specific Guidance (PSG) Program Karen Bengtson
10:20 - 10:30 AM EDT BREAK
10:30 - 10:50 AM EDT Approaches Using Proactive Research in Support of Product Specific Guidance (PSG) Development Xiaoming Xu, PhD
Darby Kozak, PhD
10:50 - 11:10 AM EDT Questions & Panel Discussion Sarah Ibrahim, PhD
Karen Bengtson
Xiaoming Xu, PhD
Darby Kozak, PhD
11:10 - 11:30 AM EDT Review of Bio-INDs in the Office of Generic Drugs Michael Spagnola, MD
11:30 - 11:50 AM EDT Overview of Pre-ANDA Meetings Susan Hakeem, PharmD
11:50 - 12:05 PM EDT Questions & Panel Discussion Karen Bengtson
Michael Spagnola, MD
Susan Hakeem, PharmD
12:05 - 12:35 PM EDT LUNCH BREAK Not offered for CE
12:35 - 12:55 PM EDT Best Practices and Strategies for Communication with FDA Robert Gaines, PharmD
Warren Simmons, PharmD
12:55 - 1:15 PM EDT Division of Filing Review: Best Practices for ANDA and Controlled Correspondence Submissions Peter Enos, PharmD, MBA, MHA
Elizabeth Kim, APRN, MSN, FNP-BC
1:15 - 1:30 PM EDT Questions & Panel Discussion Robert Gaines, PharmD
Warren Simmons, PharmD
Peter Enos, PharmD, MBA, MHA
Elizabeth Kim, APRN, MSN, FNP-BC
1:30 - 1:50 PM EDT Project Management of Premarket and Postmarket Generic Drug Safety Tu-Van Lambert
1:50 - 2:10 PM EDT Best Practices for Conducting Comparative Analyses in ANDAs Andrew Fine, PharmD
2:10 - 2:25 PM EDT Questions & Panel Discussion Tu-Van Lambert
Andrew Fine, PharmD
2:25 - 2:35 PM EDT BREAK
2:35 - 2:55 PM EDT Use of Alternate Tools for Inspections During the COVID -19 Pandemic Alexander Gontcharov, PhD
Haitao Li, PhD
2:55 - 3:15 PM EDT Office of Quality Surveillance (OQS) and the Assessment of Pharmaceutical Quality Systems (PQS) in support of ICH Q12 Alex Viehmann
3:15 - 3:35 PM EDT OPQ Policy Update - Guidance ICH Q12 Technical Considerations for Pharmaceutical Product Lifecycle Management Ashley Boam, MSBE
3:35 - 3:55 PM EDT Questions & Panel Discussion Alexander Gontcharov, PhD
Haitao Li, PhD
Alex Viehmann
Ashley Boam, MSBE
3:55 - 4:00 PM EDT Day Two Closing Michael Kopcha, PhD, R. Ph
Not offered for CE
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 12.75 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 12.75 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-045-L04-P for 12.75 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 12.75 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Bengtson, Karen, Supervisory Regulatory Health Project Manager, U.S. Food and Drug Administration - nothing to disclose
  • Boam, Ashley, MSBE, Director, CDER/OPQ/OPPQ - nothing to disclose
  • Capella, Peter, PhD, Division Director, OLDP/OPQ/CDER/FDA - nothing to disclose
  • Chen, Shujun, PhD, Senior Pharmaceutical Quality Assessor, Office of Pharmaceutical Manufacturing Assessment - nothing to disclose
  • Choe, Sally, PhD, Director, FDA/CDER/OGD - nothing to disclose
  • Coogan, Andrew, PharmD, Pharmacist, FDA - nothing to disclose
  • Coppersmith, David, JD, Regulatory Counsel, Office of Generic Drug Policy - nothing to disclose
  • Cui, Minglei, PhD, Lead Pharmacologist, FDA - nothing to disclose
  • Enos, Peter, PharmD, MBA, MHA, Pharmacist, FDA - nothing to disclose
  • Fine, Andrew, PharmD, Senior Advisor, FDA - nothing to disclose
  • Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
  • Gaines, Robert, PharmD, Program coordinator, FDA/CDER/OND/ONDP - nothing to disclose
  • Gontcharov, Alexander, PhD, Staff Fellow, FDA - I have the following relationship(s): Pfizer - Individual stocks; Pfizer - Pension plan; Viatris - Individual stocks; Lexicon - Individual stocks
  • Hakeem, Susan, PharmD, Pharmacist/Regulatory Health Project Manager, FDA - nothing to disclose
  • Holovac, David, RPh, Pharmacist, FDA/CDER/OGD - nothing to disclose
  • Ibrahim, Sarah, PhD, Associate Director, FDA - nothing to disclose
  • Keck, Victoria, VMD, MS, Lead Toxicologist, FDA/CDER Office of Generic Drugs - nothing to disclose
  • Kim, Elizabeth, APRN, MSN, FNP-BC, Controlled Correspondence Coordinator, CDER - nothing to disclose
  • Kopcha, Michael, PhD, R. Ph, Director, Office of Pharmaceutical Quality, CDER - nothing to disclose
  • Kozak, Darby, PhD, Supervisory Chemist, FDA/CDER/OGD/ORS/DTP1 - nothing to disclose
  • Lambert, Tu-Van, Regulatory Health Project Manager, FDA - nothing to disclose
  • Li, Haitao, PhD, Branch Chief, FDA - nothing to disclose
  • Li, Jinong Jenn, PhD, Chemist, OPMA/OPQ/CDER/FDA - nothing to disclose
  • Murphy, Iilun, MD, Director, CDER/Office of Generic Drugs - nothing to disclose
  • OH, BYEONGTAEK, PhD, CMC Reviewer, FDA - nothing to disclose
  • Pineiro-Sanchez, Mayra, PhD, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OLDP - nothing to disclose
  • Raines, Kimberly, PhD, Supervisory Pharmacologist, US Food and Drug Administration - nothing to disclose
  • Raw, Andre, PhD, Associate Director for Science and Communication, CDER-OPQ-OLDP - nothing to disclose
  • Roy, Partha, PhD, Director, Office of Bioequivalence, Office of Generic Drugs - nothing to disclose
  • Scheibner, Kara, Pharmacologist, FDA/CDER/OTS/OSIS - nothing to disclose
  • Shah, Rakhi, PhD, Associate Director, FDA - nothing to disclose
  • Sherwood, Edward, Director, Office of Regulatory Operations - nothing to disclose
  • Simmons, Warren, PharmD, Regulatory Project Manager, U.S. Food & Drug Administration - I have the following relationship(s): CVS Pharmacy - Employee (PRN Pharmacist)
  • Smith, Derek, PhD, Deputy Director, CDER/OPQ/OPMA - nothing to disclose
  • Spagnola, Michael, MD, Lead Physician, US Food and Drug Administration - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
  • Storms, Russell, PhD, Associate Director for Analytics, Office of Regulatory Operations - nothing to disclose
  • Tampal, Nilufer, PhD, Associate Director, CDER/OGD/OB - nothing to disclose
  • Viehmann, Alex, Division Director, FDA/CDER/OPQ/OQS - nothing to disclose
  • Woodcock, Janet, MD, Acting Commissioner of Food and Drugs, FDA - nothing to disclose
  • Wu, Geoffrey, PhD, CPH, PMP, Office Director (acting), CDER/OPQ/OLDP - nothing to disclose
  • Xu, Xiaoming, PhD, Division Director, FDA/CDER/OPQ/OPQR/DPQRV - nothing to disclose
  • Zhang, Yiyue, PhD, Senior Staff Fellow, US FDA - nothing to disclose

Planning Committee
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
  • Spagnola, Michael, MD, Lead Physician, US Food and Drug Administration - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Harrison, Catherine, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
There are no imposed requirements.