A major step for Clinical Trials

In France, the conduct of clinical trials requires a prior express favourable opinion of a Committee for the protection of the persons, in French Comité de protection des personnes (CPP).

The competent CPPs have been designated randomly, by means of a draw since a law of 2012, implemented in November 2016. However, the random designation did not take into account the workload of the CPPs or the skills of their members, which contributed to difficulties and delays.

The AFPT – Club Phase 1 had participated with France Biotech, AFCROs and DITEP in the writting of the open letter of 17 December 2017 to alert the Minister of Health to the necessity of reforming the process for the selection of CPPs.

Therefore, the AFPT – Club Phase 1 welcomes the adoption of the new Law No. 2018-892 of 17 October 2018 which stipulates that the CPP will now be randomly drawn among the committees available and with the required skills for the project review. This marks a major step towards improving the competitiveness of France in Clinical Trials.

Read the press release from France Biotech here

 

2019 EUFEMED conference – Registration is Now Open

Registration for the 2019 conference of the European Federation for Exploratory Medicines Development (EUFEMED) is now open!

The event will be held from May 15 – 17, 2019 in Lyon, France.

The conference once again has an exciting scientific programme: The Changing Landscape of Early Medicines Development: Be Prepared!

The two-day meeting will include a mixture of focused scientific sessions, interactive workshops and open forum panel discussions. Two parallel, pre-conference workshops will take place on 15 May 2018 and are dedicated to “Trial Simulation and Basic Tools” and “Early Clinical Development of Biologics – What is Special?”

Please join us in Lyon, France on May 15-17, 2019!

Learn More and Register Now

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

 

27th AGAH annual meeting – 25-27 April 2018

Wednesday April 25th to Friday April 27th

Venue: Munich

27th AGAH Annual Meeting 2018

We are most happy to invite you to the AGAH Annual Meeting in April 2018 in Munich.

The conference will focus on how to predict as well as on how to prevent adverse drug reactions in early phase drug development. The major target organ systems will be addressed: liver, kidney, CNS, cardiac function. Further sessions will be dedicated to local tolerance and immunotoxicity.

http://www.agah.eu/en/events/27th-agah-annual-meeting-2018.html

AGAH_Annual_Meeting2018_Preliminary_Programme

Registration form for the 17th Club Phase 1 annual meeting and/or PBPK symposium – 04 & 05 April 2018

Registration Form:

Click on the following link: Registration_form_04_05April2018_v19Mar2018