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Programme Hints

1st Morning Session on 26 February 2018, 11:05 – 13:00

Clinical Trials Regulation 536/2014

Moderators: Dagmar Chase and Ulrike Lorch

The “coming into effect” of the EU Clinical Trials Regulation 536/2014 is approaching, despite delays. A number of supplementary guidelines have been published in EudraLex Volume 10 and the EU Portal is being worked on feverously.

Stakeholders are making progress in getting ready and also in identifying areas of benefits and concerns. This session will provide a perfect platform for stakeholders’ views as we are moving along and gaining more insight in the new processes and procedures. Many Member States have started – and some even finalized - their local implementation of areas where the Regulation leaves room for the Member States.

EMA, industry and academic sponsors, as well as Ethic Committees and patients will be represented in this session expressing their perception – good and bad – of Regulation 536/2014.
A lively discussion following the presentations is guaranteed - don’t miss this session…

1st Morning Session on 27 February 2018, 08:30 – 10:30

GCP compliance of e-Systems and Technical Solutions
Outcome of an EMA workshop on this complex subject in June, 2017

Moderator: Alan Yeomans

The adoption of new technologies in clinical research remains complex raising numerous questions and issues with limited guidance being available.

The EMA GCP Inspectors Working Group has recently taken the initiative of inviting industry representatives to a workshop to discuss issues arising from the adoption of new technologies in clinical research.

  • What are the problems?
  • What is the consensus between regulators and the industry on what should be done to alleviate them?
  • Where is there still work to be done?

EuCROF had the privilege to be invited and contribute to this working forum; the key highlights of this meeting will be presented during the session.

2nd Parallel Session on 27 February 2018, 11:00 – 12:30

Data Protection

The emergence of patient centric approaches, digital strategies, as well as responsible data sharing policies, has generated a new issue: to protect sensitive personal data while maximising its value for innovation.

As part of the plenary session, light will be shed on the value for patients, as well as for companies, of the new EU data protection framework.

Would you like to hear how to approach an effective General Data Protection Regulation (GDPR) implementation?

Then join us for a dedicated breakout session where you could meet with experts and colleagues, and consolidate your views on some key matters, such as:

  • Taking into account the clinical trial sites’ experience, to help you setting up GDPR compliant Clinical Trial Agreements
  • Adapting your GDPR implementation to an innovative and global environment
  • Implementing de-identification standards to support secondary uses of clinical data
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