Personal Liability of the Qualified Person and Possibilities for Insurance

Discussions of a QP's liabilty and possibilties for insurance can be heard everywhere. Read more about the things that need to be considered.


FDA limits Timeframe for Responding to a 483

In a new programme starting on 15 September 2009, the FDA intends to set the timeframe for statements and responses to a 483 to a maximum of 15 business days. Read more about the new programme.


EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

The European Medicinces Agency (EMEA) has published a new Guideline on Replacement of the Rabbit Pyrogen Testing by an Alternative Testing for Plasma derived Medicinal Products to provide a possibility to cover detection gaps like fever inducing cytokines. Read more here.


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