2025 Lhasa Limited Hyderabad Symposium
Join us for a Lhasa symposium, filled with interesting presentations on ICH M7, read-across, nitrosamines, purge calculations and more
Date and time
Location
Hyderabad
Hyderabad Telangana, TS 500001 IndiaAgenda
8:00 AM - 9:00 AM
08:00 – 09:00
9:00 AM - 9:05 AM
Introduction to Symposium Overview and Agenda
Mitali Kamat - Application Scientist, Lhasa Limited
9:05 AM - 9:20 AM
Introduction to Lhasa
Laura Johnston - Associate Director, Lhasa Limited
Session 1: Classifying Impurities Under ICH M7: Expert Insights
9:20 AM - 9:45 AM
Using in silico Tools to Support Safety Assessments Under ICH M7
Roberta Drekener – Senior Application Scientist, Lhasa L
Mitali Kamat - Application Scientist, Lhasa Limited
9:45 AM - 10:05 AM
Topic to be confirmed
Mrunal Jaywant – Manager, United States Pharmacopeia Ind
10:05 AM - 10:45 AM
Practical Use Cases from an Industry Perspective: Using in silico Tools Within
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
11:05 AM - 11:25 AM
Purge Factors as Part of M7 Assessment of Mutagenic Impurity Risk
Daniel O'Connor – Senior Scientist, Lhasa Limited
11:25 AM - 11:45 AM
Applying purge argumentation to N-Nitrosamines
Andrew Teasdale
11:45 AM - 12:05 PM
Identifying the risk of nitrosamine formations via degradation pathways
Manya Arora – Application Scientist, Lhasa Limited
12:05 PM - 12:15 PM
Q&A Session
12:15 PM - 12:30 PM
Lunch Break
1:30 PM - 1:50 PM
Session 3: Nitrosamine Risk Assessment: Industry and Regulatory Perspectives
Dr. B.V. Ravichandran, Amneal Pharmaceuticals
1:50 PM - 2:10 PM
Mechanistic Foundations and Regulatory Applications
Naomi Kruhlak – FDA
2:10 PM - 2:50 PM
How do experts evaluate nitrosamine read-across? Key factors to consider
Dr. David Ponting – Principal Scientist, Lhasa Limited
2:50 PM - 3:00 PM
Q&A Session
3:00 PM - 3:10 PM
Coffee Break & Networking
Session 4: The future of nitrosamine impurity management
3:10 PM - 3:30 PM
Regulatory Session
Martin Walter, AGES
3:30 PM - 3:50 PM
Regulatory Session
Anja Langenkamp, Swissmedic
3:50 PM - 4:30 PM
Presentation by Consult Lhasa/Spektra Consulting
Mariah Ultramari, Consult Lhasa
Natan Segretti, Consult Lhasa
4:30 PM - 4:45 PM
Nitrosamine focused panel discussion
4:45 PM - 5:00 PM
Closing Remarks
Dr. Adrian Fowkes - Director of Science, Lhasa Limited
5:00 PM - 6:00 PM
Final Networking
Good to know
Highlights
- 10 hours
- In person
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.
Frequently asked questions
Up to 3 members from one organisation can attend.
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