Nitrosamines Webinar Series 

FreeThink’s latest complimentary webinar series brings together

top industry experts in this important field.

19 September 2023, 10:00 am Eastern Time (New York) 

New Approaches to set AI for NDSRI 

Mariah Ultramari, PhD, Toxicologist and CEO of Spektra Consulting 

What you will learn: 

  • Historic content focus on the acceptable limit definition for Nitrosamines 
  • Challenges to set NDSRI acceptable intakes 
  • New approaches to set AI (Acceptable Intake) – CPCA (EMA and FDA) 
  • Next steps 

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03 October 2023, 10:00 am Eastern Time (New York) 

Use of an in silico tool to determine the molecular susceptibility of compounds forming nitrosamine degradation products 

Rachel Hemingway, PhD, Principal Scientist, Zeneth Project Lead 

What you will learn: 

  • How can an in silico tool help with nitrosamine assessments? 
  • What chemical space is covered?  
  • Case studies: NDSRIs 
  • How can a database of nitrite levels in excipients aid decision making? 

Dr. Hemingway, a Ph.D. graduate in Chemistry, specializes in tumor-targeted therapeutics. Leads a team of scientists developing the Zeneth knowledge base. Expert in developing software tools to address knowledge gaps & support decision-making in the degradation community, with notable publications.

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17 October 2023, 10:00 am Eastern Time (New York) 

Understanding and Reducing Nitrosamine Formation in Solid Drug Products

Garry Scrivens, PhD, Pfizer 

What you will learn: 

Dr. Garry Scrivens is a skilled analytical chemist specializing in pharmaceutical stability and magnetic resonance spectroscopy. He has written scientific papers and co-written a book on “Accelerated Predictive Stability.” At Pfizer, Dr. Gary identifies pharmaceutical problems, improves stability, and enhances product design for better outcomes.) 

31 October 2023, 10:00 am Eastern Time (New York) 

The Chemistry of N-Nitrosamines: Insights and Implications 

Steven Baertschi, PhD, President, Baertschi Consulting 

What you will learn: 

  • Factors affecting formation in solutions and solid-state products 
  • Implications for risk assessments 
  • Potential mitigation strategies 

Dr. Steven Baertschi is a highly experienced pharmaceutical industry professional, specializing in stability, impurity, analytical, solid-state, and formulation issues. He has a proven track record of innovation and problem-solving. He has chaired scientific conferences and published extensively.) 

    Moderated by Ken Waterman, PhD, President, FreeThink Technologies, Inc. 

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