New developments in the management of clinical research projects
ECIJA organise along with Taylor Wessing and ECIJA Portugal the event: New developments in the management of clinical research projects, on 27 April from 11.30am to 1.30pm.
Clinical research with medical devices, with special reference to software. Jane Kirkby – ECIJA Portugal. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices sets out general requirements in relation to clinical investigations involving medical devices in Chapter VI and Annexes XIV and XV thereof
Integration of data protection regulations in trials – Francisco Cantueso -ECIJA Spain. Configuration of the parties involved in an investigation, obligations, controllers, processors, joint controllers.
Data protection and clinical trials: a pan-European perspective. Tim Schwarz – Taylor Wessing. Observations from a recent survey carried out.
Disclosure of data in clinical research. Alison Dennis – Taylor Wessing. The legal requirements to disclose your clinical trial data: what, how and when.
Cybersecurity. Jesús Yáñez – ECIJA Spain. Application of the NIS Directive to clinical research projects / Cyber Resilience Act.
The European Health Data Space. Marco Alexandre Saias – Taylor Wessing. What lies ahead and what are the opportunities for health sector organisations.
What’s happening with health data in the UK? Victoria Hordern – Taylor Wessing. An overview of proposed UK data protection legal reforms and other developments concerning use of health data in the UK.
Q&A – All.
(A link for online participation will be provided as soon as ECIJA confirms your participation)
