ClinicalTrials.gov and the New Final Rule (42 CFR Part 11) - Webinar CD/Transcript

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ClinicalTrials.gov and the New Final Rule (42 CFR Part 11): What Strategic Decisions Do You Need to Consider?

Many trial operators are still scratching their heads. After reading and re-reading the 177 pages of 42 CFR Part 11, “Final Rule for Clinical Trials Registration and Results Information,” can you honestly say:

  • You are certain you’re submitting everything it calls for?
  • You are in compliance with all required timelines?
  • You understand what changes under the final reg, and what remains the same?

If the answer is “no” — or even “maybe” — you’re not alone. This new final rule is full of changes large and small.

FDAnews is addressing the confusion with a new training session featuring a leading light of the FDA regulatory bar, Scott Cunningham Esq., translating the knottiest provisions of the final regulation into simple English. Here’s what you’ll discover:

  • The four elements of an “applicable drug clinical trial,” and how the FDA will interpret what these words really mean
  • Who must submit clinical trial results to ClinicalTrials.gov
  • Clinical trial data submissions deadlines
  • The enforcement landscape: What the FDA can do to police non-compliance, and when enforcement might start
  • Deciphering the ClinicalTrials.gov “voluntary submissions” provisions
  • Navigating provisions on “delayed submission” of results to ClinicalTrials.gov
  • FDA proposals for release of de-identified data — current status
  • And much more!

This training session gives you what you need to know — in just 90 minutes. Don’t risk sanctions for non-compliance. Get up to speed before the inspectors come around.

  • Medical Affairs
  • Clinical Operations
  • Regulatory Affairs
  • Publications Directors
  • Clinical Trial Regulatory Directors
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

Scott Cunningham Esq. is a partner in Covington & Burling’s San Francisco-based Food and Drug Practice Group, representing pharma, biotech, regenerative medicine, and medical device firms. His expertise covers the gamut of FDA regulatory issues, including new product development/approval, clinical trials, IRBs, Hatch-Waxman exclusivities, advertising/promotion, false claims compliance, orphan drugs, pediatric exclusivity, cGMP/manufacturing, import/export, controlled substances and SEC disclosure.