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Genotoxic Impurities in Manufacturing
October 11, 2022
Digital Conference8:30AM EST // 1:30PM BST // 2:30PM CEST
October 11, 2022
Digital Conference,
8:30AM EST // 1:30PM BST // 2:30PM CEST

Strategic risk-based approaches for cost-effective elimination of genotoxic impurities

Identify Nitrosamine Impurity Sources. Offset Analytical Burden. Ensure Product Quality and Safety.

Discover how industry leaders are tackling genotoxic impurities

Regulatory Considerations for Genotoxic Impurities

  • What  are regulators expecting from analytical vs. predictive analysis for successful drug approval? 
  • How pharmaceutical manufacturers have dealt with the presence of impurities in APIs and altered their processes.
  • With guidance on how to approach Extractables and Leachables; the importance of risk management and how current guidance can be used in anticipation of the release of ICH Q3E.

Tackling Impurities from Early to Late-Stage Development

  • Streamlining processes when dealing with impurities - with discussions lead by industry experts from Pfizer, Bristol Meyers Squibb and GlaxoSmithKline
  • Hear about life cycle approaches and working to anticipate questions of safety. With talks focusing on Risk Assessment, CMC, and GMP
  • How predictive and computational methods can be used to reduce analytical burdens and improve the efficiency of manufacturing.

Dealing with N-Nitrosamine Formation in Pharmaceuticals

  • Hear from leaders at Merck and Lhasa about de-risking synthesis of drug products to reduce the chance for the formation of genotoxic Nitrosamines
  • Overcoming the issue of eliminating or reducing the levels of impurities in drug products. 
  • Up-to-date approaches for Nitrosamine impurity detection, quantification, and removal, including analytical challenges and solutions.

Who should attend?

You will be able to find senior multinational industry leaders working in the following fields:

Non-Clinical Drug Safety and Toxicology/Genotoxicity

Drug Design/Development/Discovery/Safety

Mutagenic (Nitrosamine) Impurities

Regulatory Affairs/Validation

Extractables & Leachables

Analytical Development

API Development


Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals. Get in touch with us to discover how you can leverage your company's offering to thought-leaders and key buyers in your industry.

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1-day digital events are designed to help you cut through the noise and engage with the content that is critical to your development. Expect short-form digital events packed with detailed insights to help you elevate your knowledge in an impactful way.

Tailored Networking

Surround yourself with truly like-minded individuals who are influencing the part of the industry that is specific to you and your role. Swap tips and business cards with the leaders in clinical trials on our best-in-class digital event platform. This is your chance to position yourself as a thought-leader and develop your skills even further.

Big Ideas with Great Value

1-day digital events allow you to obtain the key updates you require at an extremely affordable rate. Obtain the critical updates specific to your research and company objectives coupled with the opportunities to meet with thought-leaders in the field - opening up easily-accessible learning opportunities like never before.

Speed and Ease

Traveling is not always the best option, especially when key projects are in progress. Now you'll be able to support your research armed with the latest tools and knowledge required for success - without the time-commitment that comes with in-person events. Truly tailored to the time-short leaders in industry, with 1-day digital events you can weave your learning opportunities within your day-to-day schedule.