Generic Drugs Forum 2022: The Current State of Generic Drugs
April 26 - 27, 2022
Virtual
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.
- 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
- 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
This activity is intended for physicians, pharmacists, and nurses.
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 |
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 |
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.
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.
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
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
There are no imposed requirements.