About Conference
The 8th Edition of the Nitrosamines Impurities Forum, scheduled for June 10-11, 2025, in Hyderabad, is a must-attend two-day event designed to provide industry professionals with the latest updates on the rapidly evolving nitrosamines landscape. Bringing together leading experts, regulatory authorities, and key stakeholders, the forum will focus on critical regulatory requirements, their impact on the global pharmaceutical supply chain, and the latest advancements in risk assessment, control strategies, and analytical methodologies.
Over two impactful days, participants will gain deep insights into various aspects of nitrosamine impurities through expert-led sessions covering regulatory frameworks, analytical techniques, and compliance challenges. Engaging panel discussions featuring distinguished industry leaders will provide thought-provoking perspectives, while exclusive networking opportunities will enable meaningful interactions with decision-makers and technical experts. Join us as we explore innovative solutions, share best practices, and shape the future of pharmaceutical safety and compliance!
Speakers
Chief Executive Officer
Nudelman ChemTox Consulting
Assistant Vice President - Regulatory Affairs
Lauras Labs Limited
Head - Global Toxicology & Nonclinical Development
Amneal Pharmaceuticals
Associate General Manager
Syngene International Limited
Vice President - Analytical R&D
Natco Pharma
Agenda
Agenda
Key Features
Pharmaceuticals
Life sciences
Bio-Pharmaceuticals
API Manufacturers
Quality Assurance
Quality Control
R&D
Production & Manufacturing
Analytical
Packaging
Regulatory
Get awareness and understanding of current regulatory guidelines, the similarities and differences across guidelines and the impact.
Learn how to derive acceptable intake limits, the challenges associated with this from both a technical and regulatory perspective.
Learn how nitrosamines are formed – The chemical mechanism behind this, the risk factors and modelling to understand the extent of formation.
Deeply understand the potential strategies to reduce risk, control of nitrite levels in excipients and other options, e.g., scavenging.
Explore analytical challenges – specific focus on NDSRIs.
Get in-depth knowledge on Toxicological studies for nitrosamines and the use of data emerging from such studies to set limits for nitrosamines, particularly for NDSRIs.
GC-MS -MS
LC-MS-MS
Orbitrap
HPLC-MS
Nitrogen Chemiluminescence
Detector
Small benchtop instruments
Industry experts assisting
Chromatographic Columns
Filters
Chemical and AR-Grade
Standards
Get in Touch
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