Entries by IDEAL

Registration opens for joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop

Registration is open for the third workshop on orphan product designation and grants jointly organised by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and, for the first time, the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA). Read more.

Input to EMA guideline on covariates

On behalf of the IDeAl consortium, Ralf-Dieter Hilgers commented 0n the ‘Draft guideline on adjustment for baseline covariates’ (EMA/295050/2013). The draft  is welcomed altogether as it yields a very good guideline on the adjustment for covariates. In his commentary, Ralf-Dieter Hilgers points out various important aspect for the usage of adjustment for covariates, for example […]

Input to EMA guideline

On behalf of the IDeAl consortium, Stephen Senn issued a comment on the MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase II dose finding studies under model uncertainty. He states that “We welcome this statement. Dose finding is one of the most difficult steps in drug development and the note […]

Social Networks

The IDeAl FP7 project is now visible on social networks!  Latest news will now also be communicated via Twitter and LinkedIn in order to ensure the dissemination of our work. Please follow us at https://twitter.com/ideal_fp7 and  @ideal_fp7 or http://www.linkedin.com/groups/IDEAL-FP7-Project-6556030.  

IDEAL – Press release

International research team develops new methods for therapy evaluation in rare diseases.   In the EU diseases that affect on average not more than 5 in 10,000 people are called rare. Worldwide, more than 7,000 such rare diseases are registered. The resulting groups of patients who are affected by a specific rare disease can be […]