Highlights of the Event

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Highlights of the Event

Regulatory developments on Nitrosamines by MHRA
Relationship to ICH M7 – similarities and key differences and impact
Nitrosamine Risk assessment using Genetic Toxicity Data
GSK R&D – Risk Assessment & Management of N-Nitrosamines
Conduction of Nitrosamine Risk Assessment within API & Drug Products
Pharmacopeial Methods
Regulatory expectations on Nitrosamines Impurities in different Markets
Recent updates on Risk Evaluation Process Guidelines
SAR evaluation of Nitrosamines
Case studies on HCTZ – cohort of concern and Candesartan
Mitigation strategies for reducing Nitrosamines formations in Drug Products
USP’s tools and solutions for Nitrosamines Impurities

Event Date

27th-28th June 2023 Van der Valk Hotel Amsterdam

For Delegate Registration

John Sebastian
+91 97388 13015
[email protected]

For Content and Speaking Opportunities

Chandni Agarwal
+91 9975625403
[email protected]

For Marketing Alliances

Simarjit Kaur
+91 99675 58540
[email protected]

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