Science and Law
12th March 2015

Pharmacovigilance, Signal Detection, and Legal Causation

You will find the information presented by both speakers extremely invaluable in advising pharmacovigilance and regulatory departments on the downstream legal significance of the significance of evidence in regulatory and company documents.

Pharmacovigilance, Signal Detection, and Legal Causation

The recent 2015 ABA Life Sciences Legal Summit was a great success!

Dr. Steve Weisman, Head of Global Healthcare Products at Innovative Science Solutions (Morristown, NJ), and Donald “Fritz” Zimmer of King & Spalding LLC, spoke on topics that were informative to both in-house and outside cousel. The panel covered the evaluation of evidence for signal detection for pharmacovigilance purposes (and possible label revisions) and for causation assessments in courts of law.

You will find the information presented by both speakers extremely invaluable in advising pharmacovigilance and regulatory departments on the downstream legal significance of the significance of evidence in regulatory and company documents. The information presented at the session may also assist outside counsel in obtaining a greater appreciation of the pharmacovigilance process within companies in meeting their regulatory obligations. Finally, the panelists also discussed how companies can proactively monitor the safety and effectiveness of their products to develop systems that reduce liability claims.

Click below to download your copy of their presentations

 

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