GMP Links to Pharmacovigilance
NA Group Leader:
John Ayres, M.D., J.D.
Eli Lilly and Company
EU Group Leader:
Johnson & Johnson
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.