FDAnews Announces — Registering “Applicable Trial” Data on ClinicalTrials.gov: What Strategic Decisions Do You Need to Consider? Webinar, June 9, 2014

While the FDA requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the ClinicalTrials.gov website, are they submitting everything necessary and complying with the required timelines? Mark the calendar for Monday, June 9, when Scott Cunningham, a partner at Covington & Burling, conducts a webinar that focuses on the new reality of US and EU reporting.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) May 29, 2014

Registering “Applicable Trial” Data on ClinicalTrials.gov:
What Strategic Decisions Do You Need to Consider?
**FDAnews Webinar**
June 9, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ApplicableTrialData

Three little words, “applicable clinical trial.” Why have they become so difficult to understand when it comes to registering trials on ClinicalTrials.gov?

That’s just the tip of the iceberg. The EU has now finalized requirements for submitting trial data into a publically accessible database

While the FDA requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the ClinicalTrials.gov website, are they submitting everything necessary and complying with the required timelines?

Still not sure about a strategy for submitting trials to ClinicalTrials.gov? Well, sponsors and clinical investigators also need to get ready to submit trials to the EU as well.

After considerable politically wrangling, the EU has finalized the obligation for sponsors to submit a results summary, regardless of the study outcome, to a publicly accessible database within one year of the trial ending, as well as an additional summary understandable to lay people.

Mark the calendar for Monday, June 9, when Scott Cunningham, a partner at Covington & Burling, conducts a webinar that focuses on the new reality of US and EU reporting. In 90 fast-paced minutes, attendees will discover:

  •     Best practices in managing and compiling with clinical trial disclosure. requirements in the United States. What success and failures have occurred in the short life of ClinicalTrials.gov submissions.
  •     The four elements of an “applicable drug clinical trial” and what does the FDA interpret these words to really mean.
  •     Who must submit clinical trials results to ClinicalTrials.gov and when should trial data be submitted.
  •     The enforcement landscape for ClinicalTrials.gov. What can the FDA do regarding non-compliance and when could enforcement start.
  •     How to decipher the ClinicalTrials.gov “voluntary submissions” provisions.
  •     How patent considerations surrounding the ClinicalTrials.gov database could impact submission strategies.
  •     How to navigate the provisions for “delayed submission” of results to ClinicalTrials.gov.
  •     How to plan controversial “expanded” results reporting requirements.
  •     The current status of FDA proposals for release of de-identified data.
  •     And much more…

Why risk fines, penalties or worse, when preparing for these new reporting rules could be so painless?

Who Will Benefit:

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

Meet the Instructor:
Scott Cunningham is a partner within Covington & Burling’s Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.

Webinar Details:
Registering “Applicable Trial” Data on ClinicalTrials.gov:
What Strategic Decisions Do You Need to Consider?
**FDAnews Webinar**
June 9, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ApplicableTrialData

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/ApplicableTrialData
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.


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