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Clinical Research in Europe: Are you ready to embrace the changes?

Joining us at the conference will once again be an opportunity for you to effectively access the most recent and pertinent updates in the field of Clinical Research and Healthcare.
In this 4th edition, Regulators, Pharma and CROs, Site experts and Patients will endeavor to provide you with valuable take-away information as well as providing ample opportunities for direct interaction with industry experts, stakeholders and your peers.

Let’s share with you, at a glance, the program outlines:

  • Brexit, and after? Everything that you want & NEED to know! How will Clinical Research be impacted, hear the perspective from the European Medicine Agency!
  • The Clinical Trials Regulation; Despite its delayed implementation, this is surely not affecting Key Stakeholders actively engaged in the implementation phase; From Regulators to Patients, hear about their strategy & how it may affect you?....
  • The New addendum to GCP E6 (R2) is now effective: Risk Based approaches in Clinical Trials are becoming the norms!
    Easier said than done! Experts will critically review where we stand and what the future may look like!
  • eTMF, eSource, Data Privacy...Operating Models are further re-defined by new regulations and guidelines; Will this facilitate implementation and compliance?
  • e-Systems and Technical Solutions: Sharing a recent discussion with GCP inspectors and their perspectives around the development and use of electronic systems.
  • Clinical Trials in Paediatric Population: Update on regulatory changes, on the pan European paediatric network and on the continuous increase in patient contribution to paediatric research.
  • European Medical Device Regulation: Experts' insight and views! Manufacturers of Medical Devices and In Vitro Diagnostics ( IVD’s ) are confronted with significant European regulatory changes. This session will address the impact of the New Medical Device Regulation with its stricter requirements for the Notified Bodies and Manufacturers as well as the actual clinical evaluation based on Meddev 2.7/1 rev.4 .
  • Data Protection Regulation (GDPR) revamped in May 2018: New principles have emerged, they will become a reality and must be implemented; Experts will present their “how to” solutions.
  • Peri and Post-approval considerations: Boldly shaping the future while not going overboard of this shaken ship? Let’s tackle the challenges such as the confusing and misleading terminology in Late Phase trials for HTA purposes, understand if patient reported outcome can be influential and the evolution toward more pragmatic low intervention trials (Adaptive licensing, EAP, PAES... ).

Program Committee Chair:

Dr Michèle Garot,
Managing Director,
CLINCellence

   
 
 
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