USP’s Workshop on Nitrosamines Impurities

Events

Workshop organized by United States Pharmacopeia (USP) in collaboration with Indian Pharmaceutical Alliance (IPA).

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AGENDA

Thursday, 16 February 2023

9:00AM-9:30AM IST
10:30PM-11:00PM EST
Welcome Address
• Mr. Girish Kapur, Vice President – India Site Operations & Site Head, USP
Keynote Address
• Jaap Venema, Ph.D., Chief Science Officer, USP
• Mr. Shirish G Belapure, Senior Technical Advisor, IPA
• USFDA India Office Speaker (TBC)
USP Leadership Address:
• Venkat Surendra Nath Koduru, Ph.D., Senior Vice President, RPO, USP
• Jennifer Devine, Ph.D., Senior Vice President, Doc Stds & Compendial Policy, USP
• Bruk Alemayehu, Ph.D., Senior Vice President, Global Lab & Technical Ops, USP Session 1, Manufacturing Insights – Sources of Nitrosamines

9:30AM-9:45AM IST
11:00PM-11:15PM EST
Topic: Potential sources of nitrosamines formation, contamination, and the need for appropriate GMP controls for APIs
Speaker: Saji Thomas, Ph.D. Vice President & Head – R&D (API) Jubilant Pharmovo Limited

9:45AM-10:00AM IST
11:15PM-11:30PM EST
Topic: Potential sources of nitrosamines formation, challenges associated with stability for Drug Products
Speaker: Tushar N Mehta, Ph.D. Vice President, Amneal Pharmaceuticals Limited

10:00AM-10:45AM IST
11:30PM-12:15AM EST
Panel Discussion: Manufacturing Insights – Sources of Nitrosamines
Moderator: Anthony Raj Gomes, Ph.D., Head of Global OSD and API Quality, Corporate Quality Assurance, Viatris Inc.
Panelists:
• Saji Thomas, Ph.D. Vice President & Head – R&D (API) Jubilant Pharmovo Limited
• Tushar N Mehta, Ph.D. Vice President, Amneal Pharmaceuticals Limited
• Rajender Kumar Potlapally, Ph.D., Senior Director, Synthetics, USP
• Raghu Palle, Ph.D., Group Vice President -API R&D, Glenmark Life Sciences

10:45AM-11:00AM IST
12:15AM-12:30AM EST
Break Session 2, Analytical Considerations

11:00AM-11:15AM IST
12:30:AM-12:45AM EST
Topic: Challenges associated with Nitrosamine analysis in API
Speaker: Industry Speaker (TBC)

11:15AM-11:30AM IST
12:45AM-1:00AM EST
Topic: Challenges associated with Nitrosamine analysis in Drug Product
Speaker: Kalyanaraman Lakshmi Narayanan, Ph.D., Vice President, and Head AR&D (OSD and Advance Characterization), Dr. Reddy’s Laboratories

11:30AM -12:30PM IST
1:00AM-2:00AM EST
Panel Discussion: Risk assessment and mitigation strategies for small and complex (NDSRIs) Nitrosamines
Moderator: Rajiv Desai, Ph.D., Senior Technical Advisor, Quality and Regulatory, IPA
Panelists:
• Mrunal A Jaywant, Ph.D., Vice President, Research and Development, USP
• Rita Santhakumar. Ph.D., Head – Analytical Development, Sun Pharmaceutical Industries Limited
• Kalyanaraman Lakshmi Narayanan, Ph.D., Vice President, and Head AR&D (OSD and Advance Characterization), Dr. Reddy’s Laboratories
• Industry Speakers (TBC)

12:30PM-1:30PM IST
2:00AM-3:00AM EST
LUNCH BREAK

Session 2 (contd.), Public / Pharmacopeial Standards

1:30PM-1:50PM IST
3:00AM-3:20AM EST
Topic: Nitrosamine impurities: Current Approaches and Future Strategy with a focus on Nitrosamine Drug-substance Related Impurities (NDSRIs) in Drug products – USP Perspective
Speakers: Ed Gump, Ph.D., Vice President – Small Molecules, USP
Mrunal A Jaywant, Ph.D., Vice President, Research and Development, USP

1:50 PM-2:05PM IST
3:20AM-3:35AM EST
Topic: (TBC)
Speaker: EDQM representative (TBC)

2:05 PM-2:15PM IST
3:35AM-3:45AM EST
Topic: Nitrosamine Exchange – community hub
Speaker: Mr. Naiffer E. Romero, Principal Scientist, Scientific Affairs & Strategy, USP Session 3, PART I: Risk Assessment for Nitrosamines in Excipients

2:15PM-2:30PM IST
3:45AM-4:00AM EST
Topic: Industry perspective – Role of excipients for nitrosamines in drug products
Speaker: B.M. Rao, Ph.D., Partner & CEO – Qdot Associates

2:30PM-2:45PM IST
4:00AM-4:15AM EST
Topic: Excipient Manufacturers perspective – Risk assessment for Nitrosamines in excipients
Speaker: IPEC Speaker (TBC)

2:45PM-3:00PM IST
4:15AM-4:30AM EST
Q&A Session: Risk Assessment for Nitrosamine Impurities in Excipients
Moderator : Satheesh Shetty, Ph.D., Senior Director, Reference Standards, USP Session 3, PART II: Toxicity Assessment

3:00PM-3:15PM IST
4:30AM-4:45AM EST
Topic: How to establish limits, Setting limits for complex Nitrosamines with case study / examples
Speaker: Raphael Nudelman, Ph.D., Teva Pharmaceutical Industries Ltd.

3:15PM-3:30PM IST
4:45AM-5:00AM EST
Topic: Application of In-silico tools (QSAR) to predict Toxicity
Speaker: David Ponting, Ph.D., Principal Scientist, Lhasa Limited

3:30PM-4:00PM IST
5:00AM-5:30AM EST
Panel Discussion: Toxicity Assessment – Nitrosamines
Moderator: Mr. Girish Kapur, Vice President – India Site Operations & Site Head, USP
Panelists:
• Raphael Nudelman, Ph.D., Teva Pharmaceutical Industries Ltd.
• David Ponting, Ph.D., Principal Scientist, Lhasa Limited
• Sebastian V J, Ph.D., International Service Lead-Nonclinical and Toxicology, Senior Director-Development Consulting and Scientific Affairs, PharmaLex India Pvt. Ltd.

4:00PM-4:10PM IST
5:30AM-5:40AM EST
Break
Regulatory Compliance – Expectations and Challenges

4:10PM-4:30PM IST
5:40AM-6:00AM EST
Topic: FDA Overview – Control of Nitrosamine Impurities in Human Drugs
Speaker: Andre Raw, Ph.D., US FDA

4:30PM-5:20PM IST
6:00AM-6:50AM EST
Panel Discussion: Regulatory expectations: GMP control, Vendor qualification, Proposed remedial actions and mitigation strategies, proactive approaches
Moderator
Milind Joshi, Ph.D., President, J B Chemicals and Pharmaceuticals Ltd.
Panelists
• Andre Raw, Ph.D., US FDA
• Jennifer Devine, Ph.D., Senior Vice President, Doc Stds & Compendial Policy, USP
• A R M Rao, Ph.D., Chief Quality Officer, Aurobindo Pharma
• Manish Gangrade, Ph.D., Vice President – Analytical R&D and Regulatory Affairs – API, Cipla Limited
• Sangeetha Ganapuram, Ph.D., Head Regulatory Affairs, Hetero Drugs
• EDQM Representative (TBC)
• Government of India – Representative (TBC)
• Industry Representative (TBC)

5:20PM-5:30PM IST
6:50AM-7:00AM EST
Closing Remarks
• Mr. Matruprasad, Senior Director, SMEA – South Asia, RPO
Vote of Thanks
• Mr. R. Karthik Iyer, Director, SCD – South Asia, RPO

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