2004D-0118 - International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Q5E)
FDA Comment Number : EC1
Submitter : Dr. Katrin Kohl Date & Time: 06/10/2004 04:06:50
Organization : Brighton Collaboration
International Organization
Category :
Issue Areas/Comments
Re: Comments on International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning


The Brighton Collaboration, formed in 2000, is an international voluntary collaboration to facilitate the development, evaluation, and dissemination of high quality information about the safety of human vaccines by enabling comparability of data through the development of harmonized (or standardized) case definitions and guidelines for pharmacovigilance on adverse events following immunization. It is currently funded by the U.S. Centers for Disease Control and Prevention and the World Health Organization.

As of April 2004, the Collaboration included >500 scientists volunteering from industry, regulatory agencies, public health, clinical care and academic organizations coming from 57 countries. Six harmonized case definition and guidelines documents have been published in January 2004 (1-6) and 17 additional harmonized definition and guidelines documents are at various stages of development. It plans to develop approximately 100 harmonized case definitions together with their respective guidelines.

The comments submitted in this document have been written by representatives of the Steering Committee (with the reclusion of Miles Braun from FDA from this submission) and the Secretariat of the Brighton Collaboration (see Annex).

The Brighton Collaboration Steering Committee and Secretariat welcome the opportunity to comment on the Draft Guidance on Pharmacovigilance Planning, and completely support the methodologies put forth in the guidance document with the suggestion of one additional topic for inclusion, i.e., harmonized case definitions, discussed in the attachment.