M-CERSI and FDA Co-sponsored Workshop

Monday, May 4, 2015
8:30 a.m.-5:00 p.m.
Food and Drug Administration's (FDA) White Oak Campus, Bldg. 31, Great Room-Section A
Ann Anonsen
301 405 0285

Mark your calendars for "Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop", sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).

About the Event:

Pharmacists and pharmaceutical and medical researchers from industry, academia, regulatory agencies and health organizations are invited to attend Big Data to Inform Drug Safety and CER: Novel Solutions to Reduce Confounding in Administrative Databases on Monday, May 4, 2015, from 8:30 a.m. to 5:00 p.m. at the Food and Drug Administration's (FDA) White Oak Campus, Bldg. 31, Great Room-Section A located at 10903 New Hampshire Avenue in Silver Spring, MD.

Comparative effectiveness, post-marketing, population-based observational studies, are well positioned to evaluate the association between medication exposures and certain drug-related outcomes and adverse events.

These observational studies employ various designs and data sources, which sometimes present a risk of bias and confounding. Commonly used  databases, which contain records of most or all medical encounters, tend to be representative of the population, large in size and have the capability of containing longitudinal information on patients. However, they may lack critical information on major health determinants or risk factors, such as health behaviors (smoking, exercise, substance use/abuse), family history, body mass index, exposure to medication samples or over-the-counter products.

This workshop will discuss creative strategies to address inadequate information capture of health factors important for pharmacoepidemiology studies relying on electronic healthcare databases.  Topics will focus on innovative methods that make use of additional data as well as methodologies exploring alternative ways that make greater use of the available data.  The workshop will provide both research and regulatory perspectives with ample time for discussions during moderated sessions.

The video recording is available by accessing the following links:

Recording 1 - https://collaboration.fda.gov/p4ur8rdnnpd/

Recording 2 - https://collaboration.fda.gov/p5ka13qpo0v/

Recording 3 - https://collaboration.fda.gov/p9p5mfuomxi/

Recording 4 – https://collaboration.fda.gov/p8kqvka4slt/




For Additional Information visit:  http://www.pharmacy.umaryland.edu/biasinbigdata/


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