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* Home * About * Topics * Speakers * Pricing * Treffen Media Select Page * Home * About * Topics * Speakers * Pricing * Treffen Media * Home * About * Topics * Speakers * Pricing * Treffen Media * Home * About * Topics * Speakers * Pricing * Treffen Media 4TH ANNUAL NITROSAMINES WORKSHOP 2ND NOVEMBER – VIRTUAL EDITION Updates, Revisions, Inclusions and Compliance Deadlines ABOUT THE WORKSHOP The USFDA issued its final guidance on Nitrosamine drug substance related impurities in August with a completion deadline on 1st November 2023. The EMA also revised their guideline in July 2023 to include Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N-nitrosamines. The research and regulations on Nitrosamines are constantly evolving which emphasizes on the need for continuous discussions on the latest developments on the subject. Following the success of the last 3 editions, Treffen Media is organising the “4th Annual Nitrosamines Workshop” on the 2nd November 2023 virtually with only recent updates, revisions and case studies on nitrosamines with focus on new inclusions in the guidelines. KEY TOPICS THIS YEAR L UPDATES ON EMA GUIDELINES WITH RESPECT TO NITROSAMINES IN DRUG PRODUCTS AND APIS L NITROSAMINE CARCINOGENICITY ASSESSMENT USING THE CARCINOGENIC POTENCY CATEGORIZATION APPROACH L REQUIREMENTS FOR COMPLIANCE WITH NITROSAMINE DEADLINES L CASE STUDIES ON MANAGEMENT OF N-NITROSAMINES AND THEIR RISK ASSESSMENT L TESTING METHODS FOR NITROSAMINES – UPDATES AND CHALLENGES SPEAKERS DR. ANDREW TEASDALE Senior Principal Scientist Impurity Management and External Advocacy, AstraZeneca DR. MIKE URQUHART Scientific Director & Senior Fellow, GSK DR. CARLA LANDOLFI CEO & Founder – Toxicology Risk Assessor, ToxHub Srl DR. GEORGE JOHNSON Associate Professor, Swansea University DR. MARKUS OBKIRCHER Director R&D, Merck Lifesciences DR. KEVIN CROSS VP Regulatory Science, Instem DELEGATE PRICING REGISTER FOR 1 * 19,000 (INR) * 350 (USD) REGISTER FOR 2 * 29,000 (INR) * 550 (USD) REGISTER FOR 3 * 39,000 (INR) * 750 (USD) REGISTER FOR 4 AND ABOVE * 12,000(INR) per participant * 200 (USD) per participant TREFFEN MEDIA BRINGING THE BEST TOGETHER Treffen Media is an experiential media company that believes in transforming industry issues and opportunities into information and idea powerhouses in every vertical we work in. PHONE +91 88490 97588 EMAIL contact@treffenmedia.com WEBSITE https://treffenmedia.com/ © Treffen Media 2023