EUFEMED First Forum – 19 September 2018

On 19 September, EUFEMED organized a successful Forum discussion at the University of Leuven in Belgium. The audience was invited to directly interact with the panel of regulators, leading to fruitful discussions to identify and mitigate risks for first-in-human and early clinical trials. Thanks to the speakers for contributing to the great success of this forum!

The presentations are available on the following link: http://www.eufemed.eu/19-sep-2018-eufemed-first-forum-ku-leuven-belgium/

30th annual meeting of GMP – 17 – 19 October 2018

For the 30th annual meeting of GMP, the AFPT president, Henri Caplain, MD, MSc gave an interesting and informative presentation focussed on the question “Transporter-medicated DDIs, are they clinically relevant?”

Download the presentation below:

Slides_Henri Caplain_Transporter-mediated drug interaction

 

 

PBPK SYMPOSIUM – 4 APRIL 2018

Download the presentations here :

Slides_Susan COLE_PBPK Modelling in Regulatory Decision-making at the European Medicines Agency

Slides_Sebastian POLAK_MPML-MechDermA-Simcyp Model

Slides_Neil PARROTT_In silico tools to study food-drug interactions, an Industry Perspective

Slides_Neil MILLER_Modelling for First-Time-In-Human Studies

Slides_John DIBELLA_Mechanistic AbsorptionPBPK Modeling to Predict PositiveNegative Food Effects.Approaches and Special Considerations

Slides_John DIBELLA_Leveraging PopPK and PBPK Modeling.Approaches to Understand FoodPPI Effects

Slides_François BOUZOM_PBPK Model Qualification and Reporting Procedures for Regulatory Submissions

Slides_David TURNER_PBPK Modelling of Food Effects

Slides_Alexis VIEL_A population WB-PBPK Model of Colistin and its Produg CMS in Pigs and exploration to humans

17th Club Phase 1 annual meeting – 5 APRIL 2018

Download the presentations here

Thierry Langer_In silico tools

Sylvie Benchetrit_PIP

Pierre Maison-Blanche_QTQTc Interval prolongation

Mike Ufer_Metabolite profiling

Gérard Sanderink_companion diagnostics

Alain Patat_EEG

Roman Galetto_CAR-T_cells