Education and Training
-
Oct 7 – 8, 2024Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products
Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products -
Nov 6 – 7, 2024Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products -
Dec 4 – 5, 2024Navigating the Transition to Low Global Warming Potential Propellants
Navigating the Transition to Low Global Warming Potential Propellants
-
May 2 – 3, 2024Considerations and Potential Regulatory Applications for a Model Master File
Considerations and Potential Regulatory Applications for a Model Master File -
Mar 14 – 15, 2024Drug-Device Combination Products: Updates and Challenges with Demonstrating Generic Substitutability
Drug-Device Combination Products: Updates and Challenges with Demonstrating Generic Substitutability -
Dec 7 – 8, 2023Characterization of Complex Excipients and Formulations
Characterization of Complex Excipients and Formulations -
Oct 12, 2023Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development
Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development -
Jun 15, 2023Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products
Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products -
May 10, 2023DDCP 101 – Identifying, Developing, and Evaluating Generic Drug Device Combination Products (DDCP)
DDCP 101 – Identifying, Developing, and Evaluating Generic Drug Device Combination Products (DDCP) -
Apr 20 – 21, 2023Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products
Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products -
Dec 6, 2022Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned
Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned -
Nov 3, 2022Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development
Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development -
Oct 27 – 28, 2022Best Practices for Utilizing Modeling Approaches to Support Generic Product Development
Best Practices for Utilizing Modeling Approaches to Support Generic Product Development -
Jun 29, 2022In Vitro Release Test (IVRT) and In Vitro/In Vivo Correlation (IVIVC) of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products
In Vitro Release Test (IVRT) and In Vitro/In Vivo Correlation (IVIVC) of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products -
Nov 30, 2021Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products
Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products -
Sep 30 – Oct 1, 2021Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches
Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches -
Aug 18 – 20, 2021In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions
In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions