Retour sur les actualités de l’AFCROs du mois de mai

  • L’AFCROs soutient les étudiants des filières Healthtech (sciences de la santé, biotechnologies, ingénierie médicale) qui rencontrent aujourd’hui d’importantes difficultés financières et de fortes inquiétudes professionnelles. Ainsi nous sommes fiers d’être partenaires de la Coalition Urgence Étudiants Healthtech.
  • Le CNCR et FHF Cancer publient un rapport inédit sur l’évaluation de la recherche en cancérologie en France
  • Les autorités de santé ont sollicité l’avis de l’AFCROs et nous avons répondu sur les deux thématiques suivantes :
    – l’amélioration de la qualité des données recueillies dans les ATU ; 
    – études en vie réelle et études post-inscription.
  • Le groupe de travail Dispositif Medical a publié un nouvel article dans la reveue Devicemed de mai-juin.
  • Ne manquez notre 13e Colloque DSVR du lundi 28 juin. Vous trouverez toutes les informations relatives à l’évènement sur ce lien.
  • Bienvenue à Linical France qui rejoint l’AFCROs.

Article DeviceMed – Loi Jardé et Règlement (UE) 2017/745 : le point sur la matériovigilance

L’entrée en application du nouveau Règlement européen des dispositifs médicaux le 26 mai prochain va modifier la marche à suivre en termes de matériovigilance lors d’une investigation clinique. Deux experts de l’AFCROs nous détaille ces évolutions.

Le point avec Nadia Zenasli et Christophe Grenot membres du groupe de travail Dispositif Médical de l’AFCROs.

Retrouvez également tous les  articles précédents publiés dans DeviceMed en cliquant ici

25 May 2021 – GDPR and Clinical Trials: Compliance and Harmonization

The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research.

Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”.

To enable mutual agreement on the rules of applying the GDPR requirements to clinical research and help CROs demonstrate compliance with the GDPR, the EUCROF task force initiated, developed and now is proud to introduce the first Code of Conduct in the industry.
The Code is aimed to explain the application of the GDPR to the services delivered by the CROs.

If you are a data protection officer, you work in a regulatory or legal department, if you are a healthcare professional wishing to boost your awareness about protection of personal data in the trial-related domain and get some insightful tips, you are welcomed to join us on this webinar!

25 May 2021, on the day of the 3rd anniversary of the GDPR, we will guide you through the first clinical trial Code of Conduct. You will have the opportunity to ask questions about the Code and our reasons to trust in its value, as well as receive practical advice on adherence.

Wébinaire EUCROF – 17 May 2021 – Staying Safe on the Way to Innovative Therapeutic Options – Phase I Trials in Research Clinics

In the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed.

In drug development the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials.
To ensure utmost safety a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol as well as for the translation into practical conduct for executing infrastructures in specialized Phase I research clinics.

The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials.

Since this law does not distinguish between the different phases of drug development starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”.

This webinar will help to understand more about the risks and benefits of early-stage clinical trials conducted in specialized Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials:

  • safety management plan
  • adequate personal resources
  • adequate locations/wards
  • adequate technical equipment
  • processes for management of emergencies
  • adequate conditions for PK sample, collection, handling and processing.

Les actualités d’avril

  • Retour sur le Printemps de la Recherche Clinique
  • Participation des patients à la Recherche Clinique : pour une participation précoce et transparente
  • Recourir au SNDS pour les études observationnelles relatives aux Dispositifs Médicaux
  • CNIL : projet de référentiel « Entrepôts de données de santé »
  • L’AFCROs présente son Rapport d’activité 2020
  • Bienvenue à nos nouveaux adhérents : Doqboard & Sunnikan Consulting