Global Regulators’ FAQs on CMC in IND/BLA Filing:
A Retrospective Look At Past Mycoplasma Validation Queries and Responses

Previously Aired on June 6th, 2019

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Every IND or BLA is different, as is every therapy being considered for regulatory approval. The CMC validation is a significant part of the regulatory filing and Interpretation of regulatory guidance is not always easy, with variability depending on the product. Thermo Fisher’s team has taken a retrospective look at some of the commonly asked regulator’s questions regarding mycoplasma testing and validation. In this webinar, we will discuss the common questions and the recommended responses.

Through this webinar you will:

• Understand some of the mycoplasma-related validation/CMC inquiries that regulators have

• Identify key areas that may require additional documentation at IND/BLA submission stage

• Gain insights into some potential responses to mycoplasma-related regulatory 


Mike Auerbach
American Pharmaceutical Review
Mike Brewer
Director, Global Principal Consultant, Regulatory,
Thermo Fisher Scientific
View Biography