AGAH discussion forum on comments to the FIH guideline
As a follow-up on the earlier discussion forum in November 2016, this discussion forum was held to develop comments to the revised FIH guideline (EMEA/CHMP/SWP/28367/07 REV.1). Mrs. Bettina Ziegele (PEI) and Dr. Stephanie Plassmann introduced and moderated the session on the "non-clinical aspects" described in points 4.3, 4.4 und 6 of the guideline. All comments of AGAH were consolidated and subsequently communicated to EMA for consultation.
Further information can be found at http://www.agah.eu/infothek/workshops/archiv/agah-diskussionsform-erarbeitung-von-kommentaren-zur-fih-guideline-emeachmpswp2836707-rev1.html