Conference Chair & Opening Remarks

Eibhlin Mulroe, CEO, Cancer Trials Ireland

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‍Innovation in Clinical Trials

• Upcoming changes and the implementation of the Clinical Trial regulation 536/2014
• Complex trial designs
• Risk based quality management in clinical trials

Sandra Bright, Clinical Assessor, HPRA (Health Products Regulatory Authority)

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Cancer Trials Ireland strategy and targets for the future

• Setting out the vision and governance
• What we can do – investigator-led trial example
• Public attitudes to clinical trials

Eibhlin Mulroe, CEO, Cancer Trials Ireland

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COVID-19 - Clinical Trials in the intensive care unit during the Pandemic. Rethinking our practices.

• Clinical trial development and conduct.
• Clinical trial staff training and education.
• Consent in the context of critically ill patients during the Covid-19 pandemic.

Natalie McEvoy, Clinical Research Nurse and PhD Scholar, Royal College of Surgeons in Ireland. Dept of Anaesthesia and Critical Care.

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Patient & Public Involvement in Clinical Trials – to infinity & beyond!

• Patient and public involvement (PPI) in clinical research, and the accumulation of evidence regarding its worth, has been implemented in Europe, the United States, Canada, Australia & the UK. Where does Ireland stand?
• Ireland is on the brink of one of the biggest advances in clinical research with health research funders supporting a national network for PPI in health research conducted in Ireland
• What does the EU Clinical Trial Directive contain?

‍Derick Mitchell, PhD; Chief Executive Officer, Irish Platform for Patient Organisations, Science & Industry (IPPOSI).  

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Research and Ethics - Details of the National Research Ethics committee - Public, Patient involvement (PPI)

• Historical and legal importance of Research Ethics
• Declaration of Helsinki, International Ethical Guidelines for Biomedical Research Involving Human Subjects, EU Clinical Trials Directive, EU Charter of Fundamental Rights, Oviedo Convention
• The role of Research Ethics Committee (REC) in clinical trials;
• The REC process
• Reform - National Research Ethics Committee for Clinical Trials- National Research Ethics Committees Bill 2019 - EU Clinical Trials Regulation

Mary Kirwan, Barrister & Lecturer @ RCSI

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Using Wearables and Smart Devices in Clinical Trials

• Why wearables in clinical trials
• Layering wearables into a large scale, multi country trial
• Wearables in 2025 clinical trials

Enda Feeney, Senior Marketing Executive, Shimmer Sensing

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Informed Consent Process, E-Consent & Documentation

• Procedural aspects of obtaining informed consent
• Constitutional rights of patients in giving and refusing consent
• The interplay between the principle of consent and the Guide to Professional Conduct and Ethics for Registered Medical Practitioners in Ireland
• E-Consent - Obtaining informed consent in the digital era

Patrick Fitzgerald,Barrister-at-Law, Law Library

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GDPR in Clinical Trials & Health Research – Smart Devices

• Progress with Understanding and Complying with the Regulation
• GDPR and Clinical Trials - Progress with Understanding and Complying with the Regulation
• The use of wearables and smart devices (from a privacy perspective)
• Health Research exemptions.
• Regulations for Long Term Archiving of Data - Audit & Inspection

Hugh Jones, EMEA Data Protection Manager, 3M

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