Biologics SIG

Established August 2008

Mission Statement

The ISPE Biologics SIG provides a forum to discuss, develop, and improve study design, analytical methods, data coding and quality for pharmacoepidemiologic studies, with special focus on the safety and effectiveness of therapeutic and diagnostic biological products, including biosimilars.


  • To increase awareness of and discuss key issues in pharmacoepidemiology research on biological medicines.
  • To foster collaboration among the SIG members using real-world data and/or methods to study biological medicines.
  • To develop, adapt and advance pharmacoepidemiologic methods in the use of real-world data in the evaluation of biological medicines.
  • To support pharmacoepidemiologic research and training in the evaluation of biological medicines.

Meeting Schedule

Generally monthly teleconference on a Tuesday at either 11 AM or 1 PM (Eastern Time)

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SIG leader(s)

Chair Marco Tuccori
Vice Chair Andrea Chomistek