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 "Handling 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 October 27, 2023, 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, and December 22. 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.
Topics Proposed to be Covered
1. Risk Assessment of Nitrosamine & Related Impurities
Risk assessment success stories of Nitrosamines & NDSRIs
2. Control of Impurities for Regulatory Compliance
Case studies - Reducing contamination, control strategies, managing suppliers, ICH M7(R2)
3. Acceptable Intake Limits for Mutagenic Nitrosamines/NDSRIs
New guidances, acceptance criteria, calculation of limits
4. Tests & Technologies for Nitrosamine Impurities
Analytical/Bioanalytical technniques, rapid detection, standard battery for genotoxicity testing, workflow solutions
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.
How to Gain Maximum Benefit
PAQ Expert Forum is a discussion forum and therefore the attendees can gain maximum out of this interaction if they actively participate in the discussion. We advise you to use these tips to get maximum benefit out of your participation
• Finalize your participation well in advance so that you get time to ponder upon the topic
• The Organizers may send you some reading material links. Please go through the reading material and prepare notes
• Carefully think about the topic and prepare a set of points you wish to clarify
• Send those questions to the organizers well in advance so that these can be shared with the experts in advance
Expert Forum Manager: Ms. Simran Kahlon, M: 7696125050, Email: firstname.lastname@example.org
Event Manager: Ms Ankita, M 7696425050, Email: email@example.com and Ms. Swati Kanwar, M: 8289015050, Email: firstname.lastname@example.org
Organizing Secretary: Ms. Farheen, M: 7696225050, Email: email@example.com
Lhasa Limited, UK
Compendial Development Laboratory at USP, India
Vice President, Head-R&D,
Metrochem API, India
Associate Vice President-Regulatory Affairs,
Amneal Pharmaceuticals, Ahmedabad, India
Head of the Department of Pharmaceutical Analysis,
NIPER- Ahmedabad, India
General manager, Regulatory Affairs,
Mylan Laboratories Limited, Hyderabad, India
Team Leader, Applications - Chromatography & Mass Division,
Thermo Fisher Scientific, India
Product Specialist, Mass Spectrometry & Automation,
Manager-GC/GCMS Product Marketing,
Shimadzu Analytical (India) Pvt. Ltd., India