Reference standards are used to ensure the continuous quality of human and veterinary vaccine products. Reference standards can be used in the assignment of vaccine potency, establishment of assay validation criteria to control assay performance and instrument calibration.
The objective of this meeting is to discuss both technical and regulatory considerations specific to the use of reference standards in the quality control of human and veterinary vaccines.
This meeting will provide opportunity to clarify a range of issues including terminology such as reference standards versus reference materials; definition of ‘fitness for use’ and how to design an effective reference standard program throughout product life-cycle, including stability, qualification and characterization studies.
A particular emphasis will be placed on the appropriate regulatory oversight and how should national regulatory authorities and international standard-setting bodies coordinate their activities to ensure the consistency of vaccine products against the specifications approved in their Marketing Authorization.
This meeting will bring together regulators, scientists, and industry experts to help resolve existing challenges and to reach consensus that will be valuable in adopting a common approach.
Participants in the workshop include:
- Industry laboratories, quality and regulatory representatives
- Representatives from worldwide regulatory agencies and organizations
- Representatives from worldwide reference standard organizations
- Contract and regulatory testing laboratories
- Supporting functions such as characterization laboratories and statistics