Title: Risk Management of the presence of Nitrosamines in medicines: Regulatory expectations
Duration: 1 hour - Available On Demand
The presence of nitrosamines, potentially carcinogenic compounds, in some chemically synthesized drugs has led to the withdrawal and supply of several drugs from the market and has raised the alarm among regulatory agencies around the world, especially in Europe. As a result of these events, a new strategy for the control and monitoring of these compounds must be defined by the pharmaceutical laboratories. What are the origins of this situation? What are the expectations of the regulatory agencies in this regard? How do we deal with the new requirements?
- EMA guidances & expectations
- Regulatory expectations for risk management of nitrosamines in medicines
- Practical approach: case study
Senior Manager, Regulatory Affairs
Diego is a biochemist and biologist by education. He has been working in the pharmaceutical industry for more than 10 years in R&D. He has spent last two years in Regulatory Affairs, focusing on CMC, such as due diligence / GAP analysis, expert reports, development activities and post approval changes. He is an acclaimed expert in CMC and Pharmaceutical development.