08:00 |
Registration
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09:00 |
Welcome Address
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India
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09:15 |
Update on Cohorts of Concern in Pharmaceuticals: Opening Remarks by the Moderator
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India
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09:30 |
Chemistry and Complete Mechanistic Understanding to help Control Nitrosamine, NDSRIs and Azido Impurities in API & Drug Products
Vinod Kansal, Former President, Amoli Organics, India
Modification of Manufacturing Process, Avoidance of Solvents that may cause formation of these impurities, like DMF, DMA and amines (inorganic bases), Routine testing for the APIS, excipients and solvents to proper control and check the level of nitrosamines etc. |
10:00 |
Moderated Open Discussion Session 1
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10:30 |
Coffee Break
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11:00 |
Origin and Mitigation Strategies for Nitrosamines, NDSRIs, Azido Impurities in API Synthesis
Narender Rao Somisetti, Vice President, Head - R&D, Metrochem API, India
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11:30 |
Moderated Open Discussion Session 2
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12:00 |
Evolving Challenges with NDSRIs and Suggested Solutions
B M Rao, Partner & CEO, QDOT Associates, India
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12:30 |
Moderated Open Discussion Session 3
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13:00 |
Lunch and Networking
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13:45 |
Cleaning Validation to Avoid NDSRIs and Genotoxic Impurities
Kiran Kota, Quality Head, SMS Pharmaceuticals Ltd, India
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14:15 |
Moderated Open Discussion Session 4
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14:45 |
European Pharmacopoeia Policy on Control of Nitrosamines, Genotoxic Impurities and EP followed Regulatory Recommendations
Ulrich Rose, Former Deputy Head, EDQM, France
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15:05 |
Moderated Open Discussion Session 5
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15:30 |
Addressing the Nitrosamines & NDSRI Challenge using Shimadzu’s UFMS Technology
Dheeraj Handique, Deputy Manager – GC/GCMS Product Marketing, Shimadzu Analytical (India) Pvt. Ltd, India
|
15:40 |
Analysis of Cohorts of Concern using Sciex Technology
Pankaj Partani, Application Support Manager, Sciex, India
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15:50 |
Coffee Break
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16:10 |
Open Discussion Session - Expert View-points/Presentations of Personal Views from Delegates
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16:40 |
Summary & Concluding Remarks by the Moderator Prof Saranjit Singh, Ex-Professor and Head, NIPER, Mohali, India
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16:50 |
Vote of Thanks by Dr Sanjay Bajaj, CEO and MD, Glostem, India
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17:00 |
End of the Meeting
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