Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part One
Pediatric Excipient Evaluation: Bioequivalence (BE) Perspective
Senior Staff Fellow
DB III | OB | OGD | CDER
GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug Applications (ANDAs)
Senior Advisor
Office of Bioequivalence Immediate Office (OBIO)
OGD | CDER
Bio-IND Best Practices: an Analysis of Common Clinical Safety Hold and Non-hold Issues and Comparative Analysis Update
Part 2: Comparative Analyses Update
Andrea Dugas, MD, PhD
Physician
Division of Clinical Safety and Surveillance (DCSS)
Office of Safety and Clinical Evaluation (OSCE)
OGD | CDER
Shabnam Foroughi, MD
Physician
Division of Clinical Review (DCR) OSCE
OGD | CDER
Successful Practices for Pharmacology/Toxicology (Pharm/Tox) Justification in ANDAs
Pharmacologist
Division of Pharmacology/Toxicology Review (DPTR)
OSCE | OGD | CDER
Q&A Discussion Panel
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part Two
Nitrosamine Risk Assessment in Type II Drug Master Files (DMFs) Supporting GDUFA Applications
Govindaraj Kumaran, PhD
Chemist
Division of Product Quality Assessment XIX (DPQA XIX)
Office of Product Quality Assessment III (OPQA III)
OPQ | CDER
Post approval changes in Complex Generics from Drug Product/Chemistry Manufacturing & Controls (CMC) Perspectives
Senior Pharmaceutical Quality Assessor
DPQA III | OPQA I | OPQ | CDER
Quality Considerations for Topical Ophthalmic Drug Products – Guidance for Industry
Senior Review Chemist
DPQA VIII | OPQA II | OPQ | CDER
Q&A Discussion Panel
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part Three
ANDA Submissions: Risk-Based Extractable and Leachable Quality Information
Kshitij Patkar, PhD
Senior Pharmaceutical Quality Assessor
Division of Pharmaceutical Manufacturing Assessment I (DPMA I)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER
Jin Xu, PhD
Senior Pharmaceutical Quality Assessor
DPQA IX | OPQA II | OPQ | CDER
Facility Assessment for Pre-Marketing Applications
GDUFA-III Implementation – Facility Related Updates
Derek Smith, PhD
Deputy Director
OPMA | OPQ | CDER
Rakhi Shah, PhD
Associate Director
OPMA | OPQ | CDER
Emerging Technology Program (ETP) and Advanced Manufacturing Technologies Designation Program (AMTDP): Which Advanced Manufacturing Program is Right for Me?
Senior Regulatory Health Project Manager
DRBPM IV | OPRO | OPQ | CDER
Q&A Discussion Panel
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day Two – Part Four
Improving the Sterility Assurance Application to the FDA
Division Director
DPMA II OPMA | OPQ | CDER
The Bacterial Endotoxins Specification – Points to Consider
Unit Supervisor
DPMA VI | OPMA | OPQ | CDER
General Overview of ANDAs Labeling Requirements for Rx to OTC Switched Products
Sunny Pyon
Labeling Project Manager
Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
OGD | CDER
Bayli Larson, PharmD
Pharmacist
Patent and Exclusivity Team (PET)
Division of Legal & Regulatory Support (DLRS)
Office of Generic Drug Policy (OGDP)
OGD | CDER
Regulatory Reminders at the Finish Line
Vincent Sansone
CAPT | USPHS
Director
DPM ORO | OGD | CDER
Rinku Patel
Program Management
DLRS | OGDP | OGD | CDER
Questions & Panel Discussion
Closing Remarks
Senior Advisor
Office of Generic Drugs
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