2026年仿制药论坛（Generic Drugs Forum 2026）嘉宾演讲PPT合集（共36套打包）

1、Top Ten Deficiencies for Liquid Drug ProductsAllison A.Aldridge,Ph.D.*Perpetue Bataille Backer,Ph.D.,Christopher Mayer-Bacon,Ph.D.,Sateesh Sathigari,Ph.D.Consumer Safety OfficerOPMA/OPQCDER|US FDAGen。

2、1A RISK-BASED APPROACH TO EXTRACTABLES AND LEACHABLES EVALUATIONSJin Xu,PhDSenior Pharmaceutical Quality Assessor FDA/CDER/OPQ/OPQAII4/23/2026www.fda.gov2DisclaimerThis presentation is not intended t。

3、Data Integrity and Data Quality Issues in Abbreviated New Drug ApplicationsKe Ren,Ph.D.Deputy Division DirectorDivision of Bioequivalence III,Office of BioequivalenceOffice of Generic Drugs|CDER|US F。

4、Closing RemarksCAPT Kendra StewartDirector,Office of Regulatory OperationsOffice of Generic DrugsCDER|U.S.FDAGeneric Drugs Forum April 23,2026fda.gov/cdersbia2Key TakeawaysAt GDF 2026 we hope you wer。

5、Overview of the FDA Product-Specific Guidance(PSG)ProgramJoseph Kotsybar,Pharm.D.Regulatory Health Project ManagerOffice of Research and Standards(ORS)|Office of Generic Drugs(OGD)|Center for Drug Ev。

6、Extractable/Leachable Safety Assessment in Generic Drug ProductsGeneric Drug Forum 2026Vince Crowley,PhDSenior PharmacologistDivision of Pharmacology/Toxicology Review(DPTR)Office of Safety and Clini。

7、Proactive Strategies to Avoid Major Filing Deficiencies&Other Stumbling BlocksTruong-Vinh(Vinh)Phung,PharmDCommander,US Public Health ServiceRegulatory OfficerDivision of Filing Review(DFR),Offic。

8、Nitrosamine Safety Assessment in Generic Drugs:A Pharm/Tox PerspectiveXin Fu,PhD,DABTDivision of Pharmacology&Toxicology Review(DPTR)Office of Safety and Clinical Evaluation(OSCE)Office of Generi。

9、Madhusudhan GowravaramUS FDA/CDER/OPQ/OPQA III/Division XVIIGeneric Drug Forum(GDF),April 22-23,2026Silver Spring,MD 20903Regulatory Review Process for Type II Secondary DMFs2www.fda.govPurposeThis p。

10、Lyophilization in Pharmaceutical Manufacturing:Deficiencies,Control Strategies,and Regulatory ExpectationsSteve RhieuCDR,US Public Health ServiceOffice of Pharmaceutical Manufacturing AssessmentCDER|。

11、FDA Perspectives on Nitrosamine Risk Reduction in Manufacturing Diaa Shakleya,Ph.DSr.Research Scientist,OPQR/OPQCDER|US FDASBIA-Generic Drugs Forum April 23,2026www.fda.gov2www.fda.gov3Disclaimer“Thi。

12、ICH M13A High-risk vs Non-high-risk Case Studies-BE ImplicationsSuman Dandamudi,Ph.D.Lead PharmacologistDivision of Bioequivalence III/Office of BioequivalenceOffice of Generic Drugs|CDER|US FDASBIA 。

13、Bioanalysis of Endogenous Drugs Using Surrogate Matrix Approach in Abbreviated New Drug ApplicationsYang Lu,Ph.D.Division of Bioequivalence IIIOffice of BioequivalenceOffice of Generic DrugsCDER,US F。

14、FDA Nitrosamine Updates and Issues Observed Yuanling Liang,Ph.D.Sr.ChemistDPQA III/OPQA I/OPQCDER|US FDASBIA-Generic Drugs Forum April 23,2026www.fda.gov2DisclaimerThis presentation reflects the view。

15、Bioequivalence Recommendations for Bridging Pre-and Post-Mitigation Formulations of Nitrosamine-Impacted Drug Products:Case StudiesParamjeet Kaur,Ph.D.,Lead PharmacokineticistMin Guo,Ph.D.,Pharmacoki。

16、Common Microbiology Deficiencies for Ophthalmic Suspension Drug ProductsArlene Chen,Ph.D.Pharmaceutical Scientist Division of Pharmaceutical Manufacturing Assessment III,Office of Pharmaceutical Manu。

17、Pre-ANDA Meetings for Complex Drug ProductsSherry Bai,PhDDivision IV,Office of Product Quality Assessment IOPQ|CDER|US FDASBIA Generic Drug Forum April 22-23,2026Dos and Donts from the Quality Perspe。

18、Drug-Device Combination Products:A Quality PerspectiveSheela Rajesh,PhDSenior Pharmaceutical Quality AssessorDivision of Product Quality Assessment IXOffice of Product Quality Assessment II(OPQA II),。

19、Product-Specific Guidances in Action:Key Lessons and Common Questions in Oral Drug Products Myong Jin Kim,Pharm.D.,FCPDirectorDivision of Therapeutic Performance II,Office of Research and Standards O。

20、Addressing Patent and Exclusivity Requirements-Regulatory RemindersHeather Strandberg,PharmDPatent and Exclusivity TeamDivision of Legal and Regulatory Support(DLRS),Office of Generic Drug Policy(OGD。

21、Prioritization Requests CDR Andrew Kim,PharmD,RACSupervisory Project Manager,Division of Project Management Office of Regulatory Operations,Office of Generic Drugswww.fda.govwww.fda.gov2Learning Obje。

22、Pharmaceutical Quality Ensuring Patients Remain Top PrioritySusan Rosencrance,PhDDeputy Director of ScienceOffice of Pharmaceutical QualityCenter for Drug Evaluation and Research(CDER)Generic Drug Fo。

23、1Melanie Mueller,PharmD PhDMaster ToxicologistDivision of Pharmacology/Toxicology Review(DPTR)Office of Safety and Clinical Evaluation(OSCE)Office of Generic Drugs(OGD)CDER/US FDAwww.fda.govStandardi。

24、Controlled CorrespondenceMinimizing Rejections,Maximizing ResultsLCDR Marcia Fields,PharmDRegulatory OfficerLieutenant Commander,US Public Health ServiceOffice of Regulatory Affairs(ORO),Immediate Of。

25、Letters of Authorization-What FDA Wants You to KnowDeborah F Johnson,Ph.D.SupervisorOPQAIII Div XIXCDER|US FDAGDF 2026-Apr 23rd2026www.fda.govwww.fda.gov2Intro What is a letter of authorization(LOA)L。

26、Suitability PetitionsGeneric Drugs Forum Generic Drugs Forum April 22,2026April 22,2026Karen Rothschild,JDRegulatory CounselOffice of Generic Drugs(OGD)Office of Generic Drug Policy(OGDP)Division of 。

27、Decoding Product-Specific Guidances(PSGs)for Complex Non-Oral GenericsYan Wang,Ph.D.Deputy Division DirectorOffice of Research and Standards(ORS)|Office of Generic Drugs(OGD)|Center for Drug Evaluati。

28、Prioritizing Original and Supplemental ANDAsBayli Larson,PharmD,BCPSPharmacist,Patent and Exclusivity TeamDivision of Legal and Regulatory Support,Office of Generic Drug Policy,Office of Generic Drug。

29、An Update on CDERs Quality Management Maturity ProgramEric TwumRegulatory SpecialistOffice of Quality Surveillance,Office of Pharmaceutical QualityCDER|U.S.FDAGeneric Drug Forum April 22,2026www.fda.。

30、Common Manufacturing Process Deficiencies for Complex Dosage Forms(TDS,MDI,DPI)Amit Kokate&Vicky HeOffice of Pharmaceutical Manufacturing AssessmentOPQ/CDER|US FDASBIA GDF April 2026www.fda.govww。

31、Factors that Can Facilitate Assessment of Type II Drug Master Files(DMFs)Erin Skoda,Ph.D.Supervisory Pharmaceutical ScientistOffice of Product Quality Assessment III,OPQCDER|US FDASBIA Generic Drug F。

32、Working Together to Increase Access to Generic DrugsOffice of Generic DrugsDr.Darby KozakGeneric Drugs ForumApril 9,2026Driving AccessState of the Generic Drug Program:Key Approval&Receipt Metric。

33、How Orange Book Listings AreAdded,Updated,and MaintainedA practical look at Orange Book database workflowsTruong Quach,PharmDLead PharmacistOffice of Generic Drugs Office of Generic Drug Policy Divis。

34、Quality Considerations for Generic Oligonucleotides Likan Liang,Ph.D.Division of Product Quality Assessment XOffice of Product Quality Assessment II,OPQ,CDER Generic Drugs Forum 2026FDA White Oak Cam。

35、Common Bioequivalence Study Design Deficiencies and How to Avoid ThemZhen Zhang,Ph.D.Master PharmacologistDivision of Bioequivalence I(DBI)Office of Bioequivalence(OB)Office of Generic Drugs(OGD)CDER。

36、Using FDAs Inactive Ingredient Database(IID):Best Practices&ConsiderationsGeneric Drugs Forum(GDF)2026 April 22,202611:25 AM 11:45 AM ETCDR Diana Solana-Sodeinde,PharmD,MPHOffice of Bioequivalenc。