Maintaining the quality of vaccines through the use of references standards
Current challenges and future opportunities
Library & Archives Canada
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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
Electronic Travel Authorisation (eTA)
Visitors travelling to Canada by air are now expected to get an electronic travel authorisation (eTA) to enter Canada.
If you’re visiting Canada you’ll need an eTA to board your flight unless you’re otherwise exempted (for example, if you have a valid Canadian visa or a permanent resident card). If you have British-Canadian dual nationality you won’t be able to apply for an eTA and you’ll need to present a valid Canadian passport to board your flight to Canada.
If you’re travelling by land or sea, you won’t need an eTA when you enter Canada. However, you must travel with acceptable travel documents and identification.
For more information about the eTA system, and to apply online, visit the official Canadian government website.