GMP Links to Pharmacovigilance

NA Group Leader:
John Ayres, M.D., J.D.
Eli Lilly and Company
ayres_john_david@lilly.com

EU Group Leader:
Agnieszka Majcher-Dann
Johnson & Johnson
amdann@its.jnj.com

The GMP Links to Pharmacovigilance Interest Group will facilitate the incorporation of medical expertise and oversight in the form of a clinical assessment of the potential safety issues with product performance and Quality System elements.  Quality attributes of a product, including product specifications, are linked to patient experiences and add value to fundamental quality activities. 

The focused elements for this Interest Group are as follows:

  • Risk control linked to medical patient risk
  • To link Quality System elements to Pharmacovigilances and Approved Risk Evaluation and Mitigation Strategies (REMS)
  • To address link recalls, complaints and adverse effects
  • The establishment of and deviation from Critical Quality Attributes (CQAs) and the link to the Quality Target Product Profile (QTPP)
  • The link to Regulatory filing issues (e.g., label claims).

The mission is achieved by:

  • An improved understanding of the clinical (patient experiences) and GMP Quality Systems (product specifications)
  • Discussing case studies of positive and negative experiences in this venue
  • Contributing to global regulations and guidance as appropriate
  • Sponsoring plenary sessions, break-out sessions, and possibly a conference to bring together experts in this field.

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