Adverse Event Compliance in Drug and Biologic Clinical Trials Know What to Report, When and How

Held Jan. 28, 2010

Failure to report adverse events properly can endanger your clinical trials and research pipeline. Learn the new rules and requirements it’s the seminar that comes to you. Read on ...

Adverse event reporting just got a lot harder.

Clinical investigators face tough new regulatory filing requirements by the NIH registry … beefed-up requirements for filings with EMEA’s EudraVigilance system … and for OTC drugs, copies of the label must be included with adverse event reports.

Not only are requirements more stringent — so are sanctions. For example, records for submission to the NIH registry may not be released or published unless they include adverse event information along with other study results.

As a result, many research facilities are now drowning in adverse event data without knowing where or how to report it. Rules vary depending on who is doing the reporting (investigator, sponsor or IRB), and to whom — investigator, sponsor, IRB, the FDA or OHRP.

It’s time for you to take a fresh look at adverse event compliance – before you get a warning letter, a fine ... or worse.

Mark your calendar for Thursday, Jan. 28. FDAnews has invited noted GCP expert, clinical-research consultant and author Dr. Charles H. Pierce for a return visit. He’ll bring you up to speed on the many changes in adverse-event reporting compliance since he first conducted this webinar.

In 90 fast-paced minutes, without leaving the comfort and convenience of your own office, you’ll discover:

  • The new rules and requirements issuing from the FDA and the OHRP
  • What the FDA considers a “reportable event,” and how it often is misinterpreted
  • Recognizing a serious adverse event, and complying with the various rules that govern it
  • How to clarify responsibilities so required reporting doesn’t slip through the cracks
  • Best practices for IRBs in managing adverse-event compliance
  • The most common reporting errors — and how to avoid them
  • What happens when you fail to meet your reporting obligations —         actions the FDA and other agencies can take
  • Risks of underreporting, risks of overreporting
  • Managing the scope and severity of adverse events in premarket safety reporting
  • And lots more

Dr. Pierce will update you on the Adverse Drug Event Spontaneous Triggered Electronic Reporting (ASTER) pilot project, and show you tricks and short-cuts that help you cut the time and resources you now spend on filing with the FDA and other regulatory bodies.

This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.

Everyone in your organization with a hand in clinical trials needs to be on hand for this event — and they can be. With just one low registration fee per facility, you can sign up dozens — hundreds — of colleagues without paying one cent more.

Clinical trial adverse events are too important to be left to chance. Patient safety is at stake, as well as the success of your products. Make plans now to attend this valuable workshop set for Thursday, Jan. 28.

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  • Research and site coordinators
  • Institutional review board members
  • Study coordinators and monitors
  • Investigators
  • Principal investigators
  • Contract research organizations
  • Medical staff

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Charles H. Pierce MD, PhD, FCP, CPI, Pierce One Consulting, is a clinical research consultant serving clinical researchers in the drug, biologic and device industries. He also serves as VP for Medical Affairs, Harrison Clinical Research GmBH, a global CRO headquartered in Munich. A 19-year veteran of the clinical research industry, he serves as an adviser to several CROs, sits on university and industry boards of directors, and is author of a “Manual for Investigators.” He received his APPI Certified Physician Investigator credential in 2004.

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