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Pharmacovigilance has been defined as the
science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
medicine-related problem.
This 8 1/2" x 11" manual brings together general guidance
on the requirements, procedures, roles and
activities in this field, for both Marketing
Authorisation Holders and Competent
Authorities of medicinal products for human
use; it incorporates international
agreements reached within the framework of
the International Conference on
Harmonisation (ICH)
Volume 9a consists of
229 pages of technical guidance presented in
four parts;
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Part I deals with Guidelines for
Marketing Authorisation Holders;
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Part II deals with Guidelines for
Competent Authorities and the Agency;
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Part III provides the Guidelines for the
electronic exchange of Pharmacovigilance
in the EU; and
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Part IV provides Guidelines on
Pharmacovigilance communication
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