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If you are struggling with the requirements for Ad Promo submissions in eCTD format, join the WAYS team for a quick webinar where we answer your questions.

  • What does the June 24, 2021 date mean for your Advertising & Promotional Submissions?

  • What are the requirements during the transition period?

  • What is required (vs. encouraged) after June 24, 2021?

Allison Steffen covers it all – the final guidance, and what’s required and what’s not during the transition period and beyond!

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New technical rejection criteria are being added to the existing eCTD validation criteria to ensure study data standards are being utilized when submitting Clinical and Nonclinical data.

  • What are the new criteria?

  • What does it mean to the sponsor?

  • How does it impact your submission?

Shannon Heacock describes the new technical rejection criteria for study data, how they will impact your regulatory submission and ways to minimize the impact of the new criteria and ensure submission compliance.

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