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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
Advancing Generic Drug Development: Translating Science to Approval
September 21 - 22, 2021
Webcast

Activity Coordinators:
Lisa Misevicz (lisa.misevicz@fda.hhs.gov),  Brenda Stodart (Brenda.Stodart@fda.hhs.gov),  Maria Monroy-Osorio (Maria.Monroy-Osorio@fda.hhs.gov)
Description

This conference will advance the same concepts to help the generic industry pave a clear scientific pathway for generic drug development. We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.

References
  • Product-Specific Guidances for Generic Drug Development https://www.fda.gov/drugs/guidances-drugs/product-specific-guidances-generic-drug-development
  • Generic Drug Development https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drug-development
Learning Objectives
  • Apply various mechanisms and processes that industry can use to obtain advice from FDA to facilitate generic drug development.
  • Comprehend new developments in science, guidance, and review experience for specific types of generic drug products.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 September 21, 2021
Time Topic Speaker
8:30 - 8:45 AM EDT Day One Introduction Brenda Stodart, PharmD, MS, BCGP, RAC
Not offered for CE
8:45 - 9:00 AM EDT Keynote Janet Woodcock, MD
9:00 - 9:20 AM EDT Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Mitchell Frost, MD
9:20 - 9:40 AM EDT Alternative Bioequivalence (BE) Approaches for Data Analysis Due to COVID-19 Related Study Interruptions Yuqing Gong, PhD
9:40 - 10:00 AM EDT Quality Consideration in the Development of FDA Guidance “Temporary Policy on Repackaging or Combing Propofol Drug Products During the COVID-19 Public Health Emergency” Gloria Huang, PhD
10:00 - 10:20 AM EDT Practice and Lessons Learned for Conducting Adaptive Designs in Generic Drug Development Kairui Feng, PhD
10:20 - 10:50 AM EDT Panel Discussion and Questions Mitchell Frost, MD
Yuqing Gong, PhD
Gloria Huang, PhD
Kairui Feng, PhD
Kimberly Witzmann, MD
Stella Grosser, PhD
10:50 - 11:05 AM EDT Break
11:05 - 11:25 AM EDT Nasal Insufflation Studies for Abuse-Deterrent Formulations (ADF) of Opioids SAEID RAOFI, MS
11:25 - 11:45 AM EDT Advancement in Evaluation of Abuse-Deterrent Formulations (ADF) for Opioid Analgesics: Research and Review Perspectives Manar Al-Ghabeish, PhD
11:45 - 12:05 PM EDT PBPK Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products Fang Wu, PhD
12:05 - 12:25 PM EDT Safety Assessment of Flavors in Generic Drug Products Melanie Mueller, PhD, PharmD
12:25 - 12:55 PM EDT Panel Discussion and Questions Fang Wu, PhD
SAEID RAOFI, MS
Manar Al-Ghabeish, PhD
Melanie Mueller, PhD, PharmD
Xiaoming Xu, PhD
Huzeyfe Yilmaz, PhD
Heather Boyce, PhD
12:55 - 1:30 PM EDT Lunch
1:30 - 1:50 PM EDT Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion Wenlei Jiang, PhD
1:50 - 2:10 PM EDT Advances in Iron Colloid Products: Comparability Study Considerations from a Quality Perspective YIWEI LI, PhD
2:10 - 2:30 PM EDT Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap Bin Qin, PhD
2:30 - 3:00 PM EDT Questions and Panel Discussion Bing Li, PhD
Darby Kozak, PhD
Wenlei Jiang, PhD
YIWEI LI, PhD
Bruce Lerman, PhD
3:00 - 3:15 PM EDT Break
3:15 - 3:35 PM EDT Addressing Challenges in the Approval of Complex Ophthalmic and Otic Generic Products: Bioequivalence (BE) Perspectives Chunsheng Zhao
3:35 - 3:55 PM EDT Addressing Challenges in the Approval of Complex Ophthalmic and Otic Generic Products: Quality Perspectives Poonam Chopra, PhD
3:55 - 4:15 PM EDT Physiological Based Pharmacokinetic Modeling and Simulation (PBPK) Modeling to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making MINGLIANG TAN, PhD
4:15 - 4:45 PM EDT Panel Discussion and Questions Chunsheng Zhao
Poonam Chopra, PhD
MINGLIANG TAN, PhD
Yan Wang, PhD
Asif Rasheed, PhD
Yu Kai Kwok, PhD
4:45 - 4:50 PM EDT Closing Remarks Lei Zhang, PhD
Day 2 September 22, 2021
Time Topic Speaker
8:30 - 8:40 AM EDT Day Two Introduction Renu Lal, Pharm.D.
Not offered for CE
8:40 - 9:00 AM EDT Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs MENG HU, PhD
9:00 - 9:20 AM EDT Model-Integrated Evidence for Bioequivalence (BE) Assessment of Complex Generic Drugs Miyoung Yoon, PhD
9:20 - 9:40 AM EDT Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products Huzeyfe Yilmaz, PhD
9:40 - 10:00 AM EDT Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Matrix Formulations Yan Wang, PhD
10:00 - 10:30 AM EDT Questions and Panel Discussion MENG HU, PhD
Huzeyfe Yilmaz, PhD
Yan Wang, PhD
Daniel Willett, PhD
Miyoung Yoon, PhD
Robert Lionberger, PhD
10:30 - 10:45 AM EDT Break
10:45 - 11:05 AM EDT Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies Susan Boc, PhD
11:05 - 11:25 AM EDT Guidance on Studies Interrupted Due to COVID-19 for Nasal and Inhalation Products Vipra Kundoor, PhD
11:25 - 11:45 AM EDT Demonstrating Bioequivalence with Inhalation Spray Drug Products Sneha Dhapare, PhD
11:45 - 12:05 PM EDT Comparative Analyses for Inhalation Products Michael Spagnola, MD
12:05 - 12:35 PM EDT Panel Discussion and Questions Changning Guo, PhD
Michael Spagnola, MD
Sneha Dhapare, PhD
Susan Boc, PhD
Vipra Kundoor, PhD
Bryan Newman, PhD
BING CAI, PhD
12:35 - 1:10 PM EDT Lunch
1:10 - 1:30 PM EDT “No Difference” Standard vs. Q1|Q2 Sameness for Topical Drug Products Megan Kelchen, PhD
1:30 - 1:50 PM EDT Use of Q3 Characterization Tests for Bioequivalence (BE) of Topical Semisolid Drug Products Sameersingh (Sam) Raney, M.S., Ph.D.
1:50 - 2:10 PM EDT Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles Ahmed Zidan, PhD
2:10 - 2:40 PM EDT Virtual Bioequivalence for Topical Drug Products Eleftheria Tsakalozou, PhD
Khondoker Alam, PhD
2:40 - 3:10 PM EDT Panel Discussion and Q&A Megan Kelchen, PhD
Sameersingh (Sam) Raney, M.S., Ph.D.
Ahmed Zidan, PhD
Eleftheria Tsakalozou, PhD
Markham Luke, MD, PhD
Khondoker Alam, PhD
3:10 - 3:20 PM EDT Break
3:20 - 3:40 PM EDT Common Issues Identified in In Vitro Release Test (IVRT) And In Vitro Permeation Test (IVPT) Studies Submitted in an Abbreviated New Drug Application (ANDA) To Support Bioequivalence Josephine Aimiuwu, PhD
3:40 - 4:00 PM EDT Theoretical Principles and Best Practices: In Vitro Release Test (IVRT) Tannaz Ramezanli, PhD, PharmD
4:00 - 4:20 PM EDT Theoretical Principles and Best Practices: In Vitro Permeation Test (IVPT) Priyanka Ghosh, PhD, Ph.D.
4:20 - 4:50 PM EDT Panel Discussion and Questions Tannaz Ramezanli, PhD, PharmD
Sameersingh (Sam) Raney, M.S., Ph.D.
Markham Luke, MD, PhD
Josephine Aimiuwu, PhD
Priyanka Ghosh, PhD, Ph.D.
4:50 - 5:00 PM EDT Closing Remarks Robert Lionberger, PhD
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 14.25 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 14.25 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 JA0002895-0000-21-057-L04-P for 14.25 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 14.25 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
  • Aimiuwu, Josephine, PhD, Pharmacologist, FDA/CDER/OGD/OB/DBII - nothing to disclose
  • Al-Ghabeish, Manar, PhD, Staff Fellow, FDA/CDER/OGD/ORS/DTPII - nothing to disclose
  • Alam, Khondoker, PhD, Senior Staff Fellow, U.S. Food and Drug Administration - nothing to disclose
  • Boc, Susan, PhD, Pharmacokineticist, FDA I received Stocks from Johnson & Johnson, Target for a role as Stockholder. My spouse received Stocks from Costco, Johnson & Johnson, 3M, Pfizer, Target, Walmart, Starbucks, Coca-Cola, Proctor & Gamble, Amgen, Altria Co., Philip Morris, Viatris Inc., Kraft Heinz Co., Beyond Meat, Kroger for a role as Stockholder.
  • Boyce, Heather, PhD, Pharmacokineticist Team Leader, CDER-OGD - nothing to disclose
  • CAI, BING, PhD, DIVISION DIRECTOR, CDER/OPQ/OLDP - nothing to disclose
  • Chopra, Poonam, PhD, Chemist, OPQ - nothing to disclose
  • Dhapare, Sneha, PhD, Visiting Associate-Pharmacologist, FDA - nothing to disclose
  • Feng, Kairui, PhD, Staff Fellow, FDA - nothing to disclose
  • Frost, Mitchell, MD, medical officer, FDA CDER - nothing to disclose
  • Ghosh, Priyanka, PhD, Ph.D., Lead Pharmacologist, CDER/OGSD/ORS/DTP My spouse received Salary from Amazon.com Services LLC for a role as Employee. My spouse received Stocks from Amazon.com Services LLC for a role as Employee.
  • Gong, Yuqing, PhD, Staff Fellow, FDA - nothing to disclose
  • Grosser, Stella, PhD, Division Director, DBVIII/OB/OTS/CDER - nothing to disclose
  • Guo, Changning, PhD, Research Chemist, FDA/CDER/OPQ/OTR/DCDA - nothing to disclose
  • HU, MENG, PhD, Staff Fellow, CDER\OGD\ORS\DQMM - nothing to disclose
  • Huang, Gloria, PhD, Lead Chemist, FDA/CDER/OPQ/OLDP/DLBPII - nothing to disclose
  • Jiang, Wenlei, PhD, Senior Advisor for Innovation and Strategic Outreach, Office of Research and Standards/Office of Generic Drugs/CDER - nothing to disclose
  • Kelchen, Megan, PhD, Senior Pharmacologist, FDA - nothing to disclose
  • Kozak, Darby, PhD, Supervisory Chemist, FDA/CDER/OGD/ORS/DTP1 - nothing to disclose
  • Kundoor, Vipra, PhD, Pharmacologist, Food and Drug Administration - nothing to disclose
  • Kwok, Yu Kai, PhD, Senior Pharmaceutical Quality Assessor, FDA - nothing to disclose
  • LI, YIWEI, PhD, Supervisory Chemist, CDER/OPQ/OPMA - nothing to disclose
  • Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
  • Lerman, Bruce, PhD, Lead Pharmacologist, FDA - nothing to disclose
  • Li, Bing, PhD, Pharmacologist, FDA - nothing to disclose
  • Lionberger, Robert, PhD, Director, Office of Research and Standards - nothing to disclose
  • Luke, Markham, MD, PhD, Director, DTP, U.S. Food and Drug Administration - nothing to disclose
  • Mueller, Melanie, PhD, PharmD, Lead Toxicologist, FDA/CDER/OGD - nothing to disclose
  • Newman, Bryan, PhD, Lead Pharmacologist, OGD/ORS/DTP My spouse received Salary from AstraZeneca for a role as Employee.
  • Qin, Bin, PhD, Staff fellow, FDA - nothing to disclose
  • RAOFI, SAEID, MS, Pharmacologist, FDA - nothing to disclose
  • Ramezanli, Tannaz, PhD, PharmD, Pharmacologist, FDA - nothing to disclose
  • Raney, Sameersingh (Sam), M.S., Ph.D., Associate Director for Science, United States Food and Drug Administration - nothing to disclose
  • Rasheed, Asif, PhD, Pharmaceutical Quality Assessor, OPQA-II/OPQ/CDER/FDA - 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
  • TAN, MINGLIANG, PhD, Staff Fellow, CDER/OGD/ORS - nothing to disclose
  • Tsakalozou, Eleftheria, PhD, Staff fellow, US FDA - nothing to disclose
  • Wang, Yan, PhD, Acting team lead, U.S. FDA - nothing to disclose
  • Willett, Daniel, PhD, Chemist, US FDA - nothing to disclose
  • Witzmann, Kimberly, MD, Deputy Office Director, FDA/CDER/OGD/OSCE - nothing to disclose
  • Woodcock, Janet, MD, Acting Commissioner of Food and Drugs, FDA - nothing to disclose
  • Wu, Fang, PhD, Senior Pharmacologist, FDA - nothing to disclose
  • Xu, Xiaoming, PhD, Division Director, FDA/CDER/OPQ/OPQR/DPQRV - nothing to disclose
  • Yilmaz, Huzeyfe, PhD, Research Scientist, FDA - nothing to disclose
  • Yoon, Miyoung, PhD, Reviewer, DPM/OCP/OTS/CDER/FDA - nothing to disclose
  • Zhang, Lei, PhD, Deputy Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA My spouse received Other - Consulting fees from Alavanda Regulatory and Drug Development Consulting, Inc. for a role as Consultant.
  • Zhao, Chunsheng, Staff Fellow, Food and Drug Administration - nothing to disclose
  • Zidan, Ahmed, PhD, Senior staff fellow (Pharmacologist), FDA - nothing to disclose

Planning Committee
  • Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - 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
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 85% of the activity.