08:00 |
Registration
|
09:00 |
Welcome Address
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India
|
09:05 |
Introduction of Speakers and Participants
|
09:25 |
An update on Cohorts of Concern in Pharmaceuticals
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
|
09:40 |
Technology Presentation - Comprehensive Workflow Solutions for Monitoring Presence/ Formation of N-Nitrosamines within APIs and Drug Products
Sachin Pandey, Team Leader, Applications - Chromatography & Mass Division, Thermo Fisher Scientific, India |  |
|
10:00 |
Control of Simple & Complex Nitrosamine Impurities in Human Drugs: Learnings & Challenges
Priyanka Pawar, Associate Vice President-Regulatory Affairs, Amneal Pharmaceuticals, Ahmedabad, India
|
10:30 |
Q/A Session
|
10:40 |
Nitrosamine Control Strategies in the APIs and some Case Studies
Narender Rao Somisetti, Vice President, Head - R&D, Metrochem API, India
|
11:10 |
Q/A Session
|
11:20 |
Coffee Break
|
11:40 |
Nitrosamine impurities - Risk management strategy during new submissions and life cycle management.
Sonia Sehra, General manager, Regulatory Affairs, Mylan Laboratories Limited, Hyderabad, India
|
12:10 |
Q/A Session
|
12:20 |
Amalgamation of Analytical Strategies: A Holistic Answer to NDSRIs Risk
Ravi Shah, Head of the Department of Pharmaceutical Analysis, NIPER- Ahmedabad, India
|
12:50 |
Q/A Session
|
13:00 |
Moderated Open Discussion
Saranjit Singh, Professor (Retd.), NIPER-Mohali, India
|
13:25 |
Lunch
|
14:20 |
Purge factors as part of M7 Assessment of Mutagenic Impurity Risk using Mirabilis to assist in Control Strategies
Michael Burns*, Principal Scientist, Lhasa Limited, UK
|
14:50 |
Q/A Session
|
15:00 |
Technology Presentation - Addressing the Nitrosamine & NDSRI Challenge using Shimadzu UFMS Technology
Dheeraj Handique, Manager-GC/GCMS Product Marketing, Shimadzu Analytical (India) Pvt. Ltd., India |  |
|
15:20 |
Coffee Break
|
15:40 |
Technology Presentation - Comprehensive Application Workflows for Nitrosamine Impurities
Gaurav Kulkarni, Product Specialist, Mass Spectrometry & Automation, Agilent, India |  |
|
16:00 |
Small to Complex Nitrosamines: USP’s Perspective, Current Solutions, and Future Strategies
Mayank Bhanti, Director, Compendial Development Laboratory at USP, India
|
16:30 |
Q/A Session
|
16:40 |
Moderated Open Discussion and Closing Remarks
Saranjit Singh, Ex-Professor & Head, Department of Pharmaceutical Analysis, NIPER, Mohali, India
|
17:10 |
Vote of Thanks and Close of Conference
Sanjay Bajaj, CEO, Glostem Private Limited, India
|
.png "Thermo Fisher")
