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ONLINE TRAINING SEMINAR

FDA MedWatch and Patient Safety

Educational Purpose:

FDA has the responsibility for assuring the safety and efficacy of all regulated marketed medical products. MedWatch, the FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and consumers. The MedWatch Program provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements, and infant formulas). MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices which they prescribe, dispense, or use. This self-learning module presents the MedWatch Program goals of safety information dissemination and adverse event reporting.

Audience:

The primary audience for this course content is healthcare professional students in medical, nursing, pharmacy, dental and allied healthcare training programs. Secondary audiences include healthcare professional practitioners, caregivers and healthcare service consumers.

 

Learning Objectives:

  1. Outline the FDA's role in post-marketing safety surveillance for medical products
  2. Describe the reporting to MedWatch
  3. Discuss how reports are used by the FDA
  4. Identify ways MedWatch disseminates safety information about medical products

Approximate time to complete this course is one hour.

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Main FDA number: 1-888-INFO-FDA (1-888-463-6332)
Drug Information Number: 301-827-4570  (8:00 am - 4:30 pm Eastern Time)

 

Created, January 2007

 
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