Virtual
Event Title
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
April 12 - 13, 2023
- Date:
- April 12 - 13, 2023
- Day1:
- - ET
- Day2:
- - ET
Topics & Presentations Day 1 |
Speakers |
---|---|
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 – Keynote and Session 1 |
|
CDER Keynote |
Jacqueline Corrigan-Curay, JD, MD |
Office of Generic Drugs (OGD) 2023 Outlook and Opportunities |
Iilun Murphy, MD |
Office of Pharmaceutical Quality (OPQ) 2023 Outlook and Opportunities |
Sau (Larry) Lee, PhD |
Controlled Correspondence Program Updates under GDUFA III |
Marcia Fields, PharmD |
Submitting a Successful Controlled Correspondence for Quality-Related Questions |
Shanaz Read, PhD |
An Overview of the FDA Product-Specific Guidance (PSG) Program under GDUFA III |
Christine Le, PharmD, PMP |
Questions & Panel Discussion |
Shanaz Read, Christine Le, and Malik Imam Manina Singh, PharmD, RAC, PMP Peter Capella, PhD Xiaoming Xu, PhD Lei K. Zhang, PhD Dave Coppersmith, JD |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 2 |
|
An Overview of Pre-ANDA meetings under GDUFA III |
Savita Nigam, PhD |
Abbreviated New Drug Application (ANDA) Meeting Requests |
Tina T. Nhu, PharmD, Mc. PM, BSPharm |
GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings |
April Braddy, PhD, RAC |
A New GDUFA III Meeting: Post-CRL (Complete Response Letter) Scientific Meeting |
Tao Bai, PhD |
Questions & Panel Discussion |
Savita Nigam, Tina Nhu, April Braddy, Tao Bai, and Karen Bengtson Parth Soni, PharmD, MBA, PMP Xuan-Mai “Mai” Nguyen, PharmD |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 3 |
|
GDUFA III Metrics |
Edward “Ted” Sherwood Russell Storms, PhD |
GDUFA III Impact on DMF Assessment |
Jayani Perera, PhD |
Facility Related Updates in GDUFA III |
Daniel Obrzut, PhD |
Quality Considerations for Developing Complex Generics |
Kumara Subramanian, PhD |
Risk Evaluation and Mitigation Strategies (REMS) for Generic Drugs: Use of a Drug Master File (DMF) and REMS Modifications |
Jennifer Sarchet, MSHA, BSN, RN, Charles Kerns |
Questions & Panel Discussion |
Jayani Perera, Daniel Obrzut, Kumara Subramanian, Jennifer Sarchet, Charles Kerns, and Rakhi Shah, PhD Srinivas Behara, PhD |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 1 - Session 4 |
|
Overview of CREATES Act and Covered Product Authorizations |
Sharon Coleman, JD |
Considerations for Application Pathway: 505(b)(2) or ANDA |
Dave Coppersmith, JD |
Resources Available on the Orange Book Website |
Truong Quach, PharmD |
The Global Generic Drug Supply Chain and Need for International Dialogue |
Sarah Ibrahim, PhD |
Quality Management Maturity |
Djamila Harouaka, PhD |
Questions & Panel Discussion |
Sharon Coleman, David Coppersmith, Truong Quach, Djamila Harouaka, and Andrew Fine, PharmD, BCPS |
Day One Closing |
|
Topics & Presentations Day 2 |
Speakers |
---|---|
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 1 |
|
Best Practices for Abbreviated New Drug Applications (ANDAs) in GDUFA III |
Chitra Mahadevan, PharmD, MS Craig Kiester, RPh, MS, RAC |
Submission of In Vitro Release Test (IVRT) Data and Information for Topical Drug Products under ANDAs (3) Products |
Hui Zheng, PhD |
Submission of In Vitro Permeation Test (IVPT) Data and Information for Topical Drug Products under ANDAs |
Archana A. Manerikar PharmD, MS |
Considerations for Alternative Bioequivalence (BE) In Vitro Study Information Submitted in Nasal Drug |
Vipra Kundoor, PhD |
Structured Submission and Review (Module 3) |
Gideon (Scott) Gordon, PhD Norman Schmuff, PhD |
Information to Include with Cover Letters |
Nimmy Mathews, PharmD, MS, BCSPC, |
Questions & Panel Discussion |
Chitra Mahadevan, Craig Kiester, Hui Zheng, Archana A. Manerikar, Vipra Kundoor, G. Scott Gordon, Norman Schmuff, Nimmy Mathews, and Malik Imam, Andrew Fine
|
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 2 |
|
GDUFA III Labeling Updates and Tips |
Julie Neshiewat, PharmD, BCPS, CPH Oluwakemi O. Odesina, PharmD, BCPS, Kodilichi (Kodi) Echeozo, PharmD, BCPS, |
Overview of Major Quality Deficiencies and Approaches Available in GDUFA III |
Karen Ireland, MS, PMP, RAC-Drugs |
Drug Product Quality Tips: Drug-Device Combination Products |
Kai Kwok, PhD |
Questions & Panel Discussion |
Julie Neshiewat, Oluwakemi "Kemi" Odesina, Kodilichi (Kodi) Echeozo, Karen Ireland, Kai Kwok |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 3 |
|
Change in API Supplier: Drug Substance Quality Tips |
Keduo Qian, PhD |
Change in API Supplier: Drug Product Quality Tips |
Rajib Paul, PhD Bo Jiang, PhD |
Managing Quality Post-Approval |
Paul Schwartz, PhD Olugbenga (Gbenga) Okubadejo, PharmD |
Inspection Tips: Best Practices for Remote Interactive Evaluations and Other Alternative Inspection Approaches |
Lane Cristensen, PhD Michael Chasey, MS |
Questions & Panel Discussion |
Keduo Qian, Rajib Paul, Bo Jiang, Paul Schwartz, Olugbenga (Gbenga) Okubadejo, Lane Christensen, Michael Chasey, and Derek Smith, PhD |
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF – Day 2 - Session 4 |
|
Submitting in eCTD: Most Common submission issues and FDA plans for eCTD v4.0 |
Jonathan Resnick |
CDER NextGen Portal: What's New? |
Seyoum Senay |
Impact Assessment of the 2021 Data Integrity Notifications to Sponsors |
Nilufer Tampal, PhD |
Risk Factors for Benzene Contamination |
Pallavi Nithyanandan |
Approaches to Mitigate the Risk of Nitrosamine Impurities in Pharmaceuticals |
David Keire, PhD |
Questions & Panel Discussion |
Jonathan Resnick, Seyoum Senay, Nilufer Tampal, Pallavi Nithyanandan, David Keire, and Likan Liang, PhD |
Day Two Closing |
|
Visit CDER Small Business and Industry Assistance Page
ABOUT THIS MEETING
The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.
This year’s theme is Celebrating 10 Years of GDF and presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics.
TOPICS COVERED
- Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III)
- Product Specific Guidances
- ANDA Submissions – Best Practices and Tips
- Policy, Global & Complex Generics Updates
- Information Technology Updates
- Using Orange Book as a Resource
KEYNOTE SPEAKERS
Jacqueline Corrigan-Curay, J.D., M.D
Principal Deputy Center Director
Center For Drug Evaluation and Research (CDER) | FDA
Iilun Murphy, M.D.
Deputy Director for Clinical and Regulatory Affairs
Office of Generic Drugs (OGD) | CDER | FDA
Sau (Larry) Lee, Ph.D.
Deputy Director of Science
Office of Pharmaceutical Quality (OPQ) | CDER | FDA
INTENDED AUDIENCE
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
- plan to submit an ANDA, are in the process of submitting an ANDA, or have submitted an ANDA
- are involved in generic drug development
FDA RESOURCES
- Product-Specific Guidances for Generic Drug Development
- Pharmaceutical Quality Resources
- Industry Resources
- Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
- Federal Register Notices Related to Generic Drugs
- GDUFA Science and Research
- Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book