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Michael Hiob
Author page

Michael Hiob

Regierungspharmaziedirektor des Ministeriums für Justiz und Gesundheit des Landes Schleswig-Holstein, Kiel .

Published articles

European Safety Referral: Short and Crisp

European Safety Referral: Short and Crisp

A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).

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Change Management from an Authorities' Perspective

Change Management from an Authorities' Perspective

What are the important aspects of effective change management from an authorities' point of view?

Dr. Michael Hiob gives an overview on the relevant topics to observe when implementing changes in drug manufacturing. A detailed discussion of the change management procedure can be found in the chapter ‘Change Management’ of the GMP Compliance Adviser.

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