Michael J. Cohen, PhD

Pfizer Worldwide R&D
Research Fellow - Global Chemistry, Manufacturing, & Controls
Michael Cohen is a Research Fellow in Global Chemistry, Manufacturing and Controls (GCMC) within Pfizer Inc at the Groton, CT site. He received his bachelor’s degree in Chemistry and Mathematics at Bates College and then a Ph.D. in Analytical Chemistry at Northeastern University under the direction of Barry Karger. Mike joined Pfizer in 1985, initially as an analytical chemist but later as a Pharmaceutical Sciences Team Leader and then most recently in the GCMC group. Throughout his 34 years at Pfizer, Mike has been involved in supporting the development of new chemical entity drug products, new product line extensions and post-approval changes for market products. During this time Mike’s efforts spanned the development lifecycle from pre-clinical drug candidates through registration, and beyond. Mike’s areas of interest/expertise are in analytical methods, impurities and dissolution.

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Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
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Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

The latest ICH guideline, ICH Q12,1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019.