Webinar - WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing (CMC)

watch the webinar
06 Feb 2025

Join our second webinar of the series on the WHY, HOW, WHO, WHAT and WHEN of Regulatory Writing on Thursday 6 February 2025. Following our first webinar on general aspects on Thursday 16 January 2025, this webinar will delve deeper into the various documents required for early development and highlight the importance of involving skilled regulatory and medical writers from a CMC perspective. Our third and final webinar of the series on 27 February will focus on Non-Clinical & Clinical.

Key learnings:

CMC Regulatory aspects/regulatory writing considerations for:

  • IND/IMPD submissions;
  • Agency meetings and briefing books
  • CMC for MAA/BLA submissions;
  • NCE/ NBE differences in CMC writing;
  • FDA/EU differences.

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