EN PL

GMP: GVP Update

29.09.2016
On 8 August 2016, draft revision 2 of Module VI on management and reporting of adverse reactions and draft revision 1 (major revision) of Module IX on signal management with its Addendum I (Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions) were released for public consultation until 14 October 2016.