The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.

The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for ...

In minutes from their meeting in Singapore last November, the International Council for Harmonisation (ICH) Management Committee and Assembly provide updates on a range of issues not covered in ...

At ICH’s November 2016 meeting, the council announced new members and new guidelines. The International Council for Harmonization (ICH) announced it was developing a new guideline on the collection of ...

Several "standard care" therapies for ICH are not as effective as once thought and are no longer recommended in updated guidelines.

Noting that "current guidelines equivocate about the use of antithrombotic and statin medications after ICH because of the perceived risk of recurrent ICH," Simonetto and Murthy say the present ...

DUBLIN--(BUSINESS WIRE)--The "The New ICH GCP E6 R2 Guideline" conference has been added to Research and Markets' offering With the new ICH GCP E6 Revision 2 changes now finalised and needing to ...

The Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2) (GCP E6 R2) contains 26 significant changes, such as: new sections on investigator responsibilities, a new ...