Overview

PharmaAQ (Pharma Analysis and Quality) Experts Forum is a technical discussion group comprising of R & D Heads, Senior Team Leaders, and Scientists from Analytical and Quality control domains. The forum envisages bringing together the Pharma company scientists at a platform to discuss the hottest issues and explore solutions for achieving research and business objectives.

The presence of nitrosamines, NDSRIs, and other mutagenic impurities in pharmaceuticals has emerged as a significant and pressing concern, casting a shadow over the safety and quality of drug substances and the products they develop. Regulatory authorities worldwide have responded promptly to this concern, implementing stringent guidelines and regulations to ensure the mitigation and control of nitrosamine-related risks. In light of the ever-evolving regulatory standards and the imperative to prevent costly recalls, the proactive detection of genotoxic contaminants must become an integral part of every phase of pharmaceutical development. By identifying and addressing these impurities early on, pharmaceutical companies can ensure compliance with the latest ICH M7 and ICH Q3D guidance updates, thereby minimizing risks to both patient well-being and the reputation of the industry.

To foster a comprehensive understanding of these challenges, we are organizing a meeting that will assemble the industry experts on the theme "Managing Nitrosamines & NDSRIs in Pharmaceuticals". This platform will facilitate a diverse exchange of perspectives on handling mutagenic impurity concerns, covering topics such as regulatory-compliant drug impurity profiling, effective strategies for adhering to guidelines, methodologies for identifying and quantifying nitrosamine impurities, genotoxic risk assessment, tackling analytical hurdles, predicting genotoxicity, establishing acceptable intake limits, and the latest advancements in the impurity analysis. This event seeks to collaboratively address the complex web of issues surrounding mutagenic impurities, with the help of Case studies & Success stories, equipping participants with knowledge and strategies to confidently navigate these challenges. By harnessing the collective expertise of our speakers and participants, we aim to foster a safer and more resilient pharmaceutical landscape, ensuring that the well-being of patients remains at the forefront of industry priorities.

This discussion forum will be held on June 14, 2024, in Mumbai and is brought to you by the organizing team of Pharma Analysis and Quality conferences, Masterclasses & Expert forums as well as Round-table meetings on Nitrosamine Impurities in December 2019, February 2020, December 22 and October 23. Guided by the experienced hand of Professor Saranjit Singh (Retd.), this forum will serve as a platform for in-depth discussions on practical considerations, focusing particularly on nitrosamines and genotoxic impurities within the pharmaceutical realm. The esteemed professor will lead moderation, steering the conversations towards insightful explorations of real-world intricacies in this domain.

Who Should Attend

Heads, Vice Presidents, Directors, Senior Managers, Team Leaders, and Senior Scientists from Pharma and CRO Organizations working in various domains: Analytical Method Development, Quality control, Formulation Development, Regulatory Affairs, Quality Assurance, Pharma R&D, Manufacturing chemists, and pharmaceutical manufacturers.

Organizing Secretary

Ms. Swati Kanwar, M: 8289015050, Email: s.kanwar@glostem.com

Forum Manager

Ms. Farheen, M: 7696225050, Email: f.zainab@glostem.com

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Conference Agenda

  • Risk Assessment Approaches for Nitrosamine & Related Impurities
  • Acceptable Intake/Control Limits for NDSRIs
  • Control & Mitigation of Nitrosamine Impurities for Regulatory Compliance
  • Tests, Methods and Vendor Innovations for Nitrosamines/NDSRIs Determination

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