15.06.2015 – 16.06.2015

Venue: Bonn

New European Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms

Save the date announcement for a brand new workshop!

The development of modified release formulations still is a challenge for applicants and authorities as well. From 'which studies are needed when' to 'how to optimize the study design' – a broad variety of scientific and regulatory aspects need to be considered for new modified release forms of new chemical entities and known drugs, but also for abridged applications.

The new European Guideline has brought some changes and also some clarification especially with regard to orally administered drugs. The first day of this workshop is intended to adress specifically the new requirements regarding oral formulations.

The second day will focus on patches regarding the PK studies necessary but also of course patch adhesion trials and skin irritation and sensitization studies.

The workshop is intended for participants from industry- and CRO side as well as for regulators and investigators involved in drug development. A group of highly experienced experts together with representatives from authorities will present the relevant aspects to be observed and will share their specific experience and knowledge with you.

The workshop has been initiated by AGAH together with the EUFEPS Network on Bioavailability and Bioequivalence.