It appears that materials from the Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop are now available. 
Workshop Recordings
Session 1: Nitrosamine Drug Substance-Related Impurities (NDSRIs)
Presentations
- Public Comment Presentations on NDSRIs (PDF – 2.73 MB)
- N-Nitrosamine SAR Modeling of Potency – Current Status and Future Needs (PDF – 1.24 MB)
Kevin P. Cross, PhD
VP, Regulatory Science, PI, FDA Research Collaborations, Instem - N-Nitrosamine Drug Impurity Research at FDA/NCTR: Assessing the Mutagenicity of N-Nitrosamines and NDSRIs (PDF – 1.56 MB)
Xilin Li, PhD
Visiting Scientist, DGMT, NCTR, FDA - NDMA and Beyond: A Biased Kinetic Model to Assess Nitrosation Risk in Solid Drug Products (PDF – 1.56 MB)
Dr. Ian W. Ashworth
Principal Scientist, Chemical Development, AstraZeneca, Macclesfield, UK - CMC Considerations and Bridging Bioequivalence Studies of Reformulated Products Impacted by Nitrosamines (PDF – 739 KB)
Martin Ehlert, PhD
Vice-president, API R&D, Apotex Inc. - Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS Based Waiver of In Vivo BE Studies (PDF – 623 KB)
Fang Wu, PhD
Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA - Nitrosamine Impurities: Beyond a Compendial Standard - Learnings from USP’s Nitrosamines Exchange Community (PDF – 3.37 MB)
Naiffer Romero, MSc, MPH
Principal Scientist, Scientific Affairs - US Pharmacopeia