Practical Approaches to Lifecycle Signal Detection Using the Right Tools to Develop an Ideal Signal Management System

Held March 22, 2011

The EMA has found that statistical signal detection can provide more than a 50 percent increase in the detection of many drug-related problems … and has recommended it be added to routine pharmacovigilance for optimal safety in the monitoring of drugs.

By September of this year the FDA expects to revamp its adverse event reporting system with improved data mining capabilities and better integration with other FDA postmarket safety activities — and they are encouraging industry to develop more extensive statistical and data mining capabilities.

This webinar, covering the practical approaches of signal detection (and other new innovations) will help you get an early start towards understanding signal detection and implementation.

Pharmacovigilance will never be the same. Statistical signal detection will transform the process, according to an EMA study that found that it boosted early detection of drug-related problems by a stunning 54 percent.

But signal detection is still so confusing that many drug and biologics manufacturers — small and large — are uncertain of its potential, let alone how to implement it.

To remedy this situation, FDAnews has called in a signal-detection expert to lead an upcoming webinar.

Mark your calendar for Tuesday, March 22, when Dr. Elizabeth Garrard of Drug Safety Alliance, Inc., will conduct an intensive learning session on this important new modality.

Via case studies, you’ll learn the foundations of signal detection that can deliver better results, from basic sorting and imputation screening methods … to more complex disproportional methods ... to new innovations.

You’ll also get examples of recent FDA actions precipitated by product risk identification and how proactive signal programs (coupled with technology solutions) can identify and mitigate risk earlier in the product life cycle.

You’ll also learn:

  • The difference between safety finding and signal detection — what a signal really requires
  • How to use innovative data visualization techniques to improve early detection
  • 8 benefits of effective signal management programs
  • Traditional v. data mining techniques for signal detection
  • Processes for signal detection — detection, prioritization, assessment and evaluation
  • Explanation of CIOMS VIII, the new signal standard
  • What the future holds for Signal Detection

Like every FDAnews webinar, Practical Approaches to Lifecycle Signal Detection is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.

Of course, Dr. Garrard will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in drug risk identification deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

The FDA and the EMA are moving forward with lifecycle signal detection. They expect you to get up to speed, too, and fast. Don’t risk sanctions — or, much worse, liability lawsuits. Master this important new technique. Sign up now

If you work in drug or biologics manufacture, or a CRO, this webinar is a perfect opportunity to acquire key new skills. It’s perfect for:

  • Executive Management
  • Regulatory Affairs
  • Medical Affairs
  • Research and Development
  • Clinical Trial Directors
  • And everyone else whose job involves pharmacovigilance implementation

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

Elizabeth Garrard, PharmD., R.Ph., is Chief Safety Officer of the Drug Safety Alliance, Inc. (DSA). She is responsible for leadership in strategic planning, analysis, development, implementation and measurement of all aspects of drug safety, pharmacovigilance and risk management. Dr. Garrard has more than 30 years of clinical and regulatory experience spanning the pharmaceutical, clinical, pharmacovigilance, hospital and retail industries.

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