About this Event
We’re excited to return to India for the Lhasa 2025 Hyderabad Symposium on Thursday, 6th November.
Join us for this free, one-day event, where industry and regulatory experts will share insights on ICH M7, Nitrosamines, Purge Calculations, and more.
To secure your spot, join the waiting list via the event page and we’ll be in touch to confirm your attendance. More details, including our guest speakers and agenda, will be announced soon.
For ticket access, please create an Eventbrite account or download the Eventbrite app.
We look forward to seeing you there.
Agenda
🕑: 08:00 AM - 09:00 AM
08:00 – 09:00
Info: Registration & Morning Refreshments
🕑: 09:00 AM - 09:05 AM
Introduction to Symposium Overview and Agenda
Host: Mitali Kamat - Application Scientist, Lhasa Limited
🕑: 09:05 AM - 09:20 AM
Introduction to Lhasa
Host: Adrian Fowkes, Director of Science, Lhasa Limited
Info: Leveraging Innovation to Inform Chemical Safety Decisions
Session 1: Classifying Impurities Under ICH M7: Expert Insights
🕑: 09:20 AM - 09:45 AM
Using in silico Tools to Support Safety Assessments Under ICH M7
Host: Roberta Drekener – Senior Application Scientist, Lhasa L
Info: Overcoming Challenges in Expert Review [Interactive session]
🕑: 09:45 AM - 10:05 AM
Topic to be confirmed
Host: Chintalapati Krishnam Raju, Principal Scientist
🕑: 10:05 AM - 10:45 AM
Practical Use Cases from an Industry Perspective: Using in silico Tools Within
Host: Muzaffar Khan – DGM, Regulatory Affairs; Laurus Labs
🕑: 10:45 AM - 10:55 AM
Q&A Session
🕑: 10:55 AM - 11:05 AM
Coffee Break & Networking
Session 2
Info: Comprehensive Strategies for Potentially Mutagenic Impurity Formation and Control: Nitrosamines and Beyond
🕑: 11:05 AM - 11:25 AM
Purge Factors as Part of M7 Assessment of Mutagenic Impurity Risk
Host: Daniel O'Connor – Senior Scientist, Lhasa Limited
🕑: 11:25 AM - 11:45 AM
Applying purge argumentation to N-Nitrosamines
Host: Andrew Teasdale
🕑: 11:45 AM - 12:05 PM
Identifying the risk of nitrosamine formations via degradation pathways
Host: Manya Arora – Application Scientist, Lhasa Limited
🕑: 12:05 PM - 12:15 PM
Q&A Session
🕑: 12:15 PM - 12:30 PM
Lunch Break
🕑: 01:30 PM - 01:50 PM
Session 3: Nitrosamine Risk Assessment: Industry and Regulatory Perspectives
Host: Dr. B.V. Ravichandran, Amneal Pharmaceuticals
🕑: 01:50 PM - 02:10 PM
Mechanistic Foundations and Regulatory Applications
Host: Naomi Kruhlak – FDA
Info: Recorded Presentation on CPCA
🕑: 02:10 PM - 02:50 PM
How do experts evaluate nitrosamine read-across? Key factors to consider
Host: Dr. David Ponting – Principal Scientist, Lhasa Limited
🕑: 02:50 PM - 03:00 PM
Q&A Session
🕑: 03:00 PM - 03:10 PM
Coffee Break & Networking
Session 4: The future of nitrosamine impurity management
🕑: 03:10 PM - 03:30 PM
Regulatory Session
Host: Martin Walter, AGES
🕑: 03:30 PM - 03:50 PM
Regulatory Session
Host: Anja Langenkamp, Swissmedic
🕑: 03:50 PM - 04:30 PM
Presentation by Consult Lhasa/Spektra Consulting
Host: Mariah Ultramari, Consult Lhasa
🕑: 04:30 PM - 04:45 PM
Nitrosamine focused panel discussion
🕑: 04:45 PM - 05:00 PM
Closing Remarks
Host: Dr. Adrian Fowkes - Director of Science, Lhasa Limited
🕑: 05:00 PM - 06:00 PM
Final Networking
Event Venue & Nearby Stays
Hyatt Place Hyderabad Banjara Hills, Road Number 1, Hyderabad, India
GBP 0.00
