BM Rao, Ph.D, Dr. Reddy’s Laboratories - Qepler Summits And Conferences

BM Rao, Ph.D

VP & Head – Emerging Markets, Analytical Science & Technology & Corporate Quality control
Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories, a leading multinational pharmaceutical company based in India and overseas, committed to providing affordable and innovative medicines for healthier lives.

Related Sessions:

3rd Annual Genotoxic Impurities
in Pharmaceuticals Summit 2023

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 09 Mar 2023
  • Virtual,
  • Pharma
Day 2: Friday, 10 March 2023
CASE STUDY: Recent updates on Nitrosamine Impurities by EMA & FDA
  • Background on Nitrosamine impurities
  • The updates introduced in FDA and EMA regulations
  • Risk assessment, Confirmatory Testing and Control Strategy
  • Regulatory considerations
  • New frontiers in techniques and technologies in Nitrosamine impurities quantification
  • Analytical methods development, validation, and testing – Practical challenges and suggested solutions
  • Walkthrough of compendial testing requirements
  • Uncertainties, misalignment, investigations, observations, and experiences related to nitrosamine impurities
  • How to write comprehensive risk assessment reports?
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