History and liability of Qualified Persons

Category: compliance, product liability Industry: healthcare, cosmetics Author: Year:

pharma technologie journal

A publication by Miriam Schuh in 'The Qualified Person', 2nd issue 2018

Duties, obligations and responsibilities in accordance with the Medical Preparations Act (AMG) and the Regulation on the Manufacture of Medical Preparations and Active Substances (AMWHV)

In her article, Miriam Schuh looks at the liability of the Qualified Person and explains

  • basic principles of liability
  • scope of liability and options
  • how to limit one's own liability risk

It is absolutely necessary for manufacturers of medicines to have a Qualified Person who bears overall responsibility for manufacture and quality control. Not only the company itself but also the Qualified Person must take all necessary precautions to prevent any danger to consumers.

to the reading sample

Further information from the publisher Editio Cantor Verlag

[9 May 2018]