For 2011, the FDA has dramatically changed the rules for drug and biologics trials.

The new rules will 1) reduce unnecessary reporting of events that aren’t relevant to a drug, and 2) force investigators and sponsors to do a better job identifying the events that are relevant.

There’s no doubt that these new requirements will increase the regulatory burden on drug and biologics trial sponsors and investigators already laboring under a heavy load.

That’s why the new special report Adverse Event Reporting for Drug and Biologics Trials is essential for busy executives involved in clinical trials and regulatory affairs.

Take a look at all you’ll discover:

• New FDA requirements for adverse event reporting
• New deadlines for compliance
• What’s new in adverse event reporting — changes you must make
• What’s new in safety surveillance and monitoring — changes you must make
• How sponsors must establish baseline incidence rates
• The impact of privacy laws on your new responsibilities
• Tips for A-to-Z compliance
• And much more

Best of all, Adverse Event Reporting covers the topic thoroughly in plain, easy-to-understand English — not the regulatory-ese of the Federal Register.

If you operate drug and biologics clinical trials and report adverse events, you need to get up to speed on these new requirements — fast. Order your copies of Adverse Event Reporting for Drug and Biologics Trials: 2011 Changes to the Requirements for practical information that will keep you on the FDA’s good side as the agency blazes new compliance trails for 2011.

Buy Now
Adverse Event Reporting for Drug and Biologics Trials: 2011 Changes to the FDA Requirements is available in print and PDF format for $327. For fastest delivery — and $10 savings — order the PDF edition and enjoy instantaneous electronic delivery. Act now: place your order here.

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