Start Time
9:15 AM
End Time
3:45 PM
DELIVERY
Virtual
There will be CPD hours awarded to attendees. Please check directly with your association or awarding body to see how many points they will award.

About this Conference

Clinical Trials in Ireland are continuously developing, whether it be new technologies, new devices, new regulation, or new guidelines it’s a fast-paced sector of healthcare that professionals need to keep themselves up to speed on.

This virtual conference will focus on the key areas, of Data, AI, Smart devices, wearables, and advances in Clinical trials taking them to the next level.

The recent pandemic has shown us we need to be prepared for everything and anything and the need to be far more advanced going forward.

This is a unique virtual event from our own custom-built CMG Studios. Initial feedback has been overwhelmingly positive, with attendees praising the additional interactive elements, as well as increased Q&A opportunities throughout the day, giving you more opportunity to gain real practical insights on the key issues that are important to you.

Agenda

Conference Chair & Opening Remarks

Eibhlin Mulroe, CEO, Cancer Trials Ireland

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)

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

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.

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).  

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

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

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

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

Who Should Attend?

This conference will be of real interest and benefit to all who work in the clinical trial space including Clinical Operations, Clinical Development, Clinical Innovation, R&D, Clinical trial managers, Clinical Project Managers, Healthcare Innovation and technology, Medical Affairs, Digital Health and Transformation, Patient Advocacy, data management and privacy specialists, legal and Regulatory Affairs, Patient Recruitment to name just a few

Speakers

Sandra Bright
Clinical Assessor, HPRA (Health Products Regulatory Authority)
Eibhlín Mulroe
CEO of the Cancer Trials Ireland
Natalie McEvoy
Clinical Research Nurse and PhD Scholar, RCSI
Derick Mitchell, PhD
Chief Executive Officer, Irish Platform for Patient Organisations, Science & Industry (IPPOSI)
Mary Kirwan BL
Barrister & Lecturer at RCSI
Hugh Jones
EMEA Data Protection Manager at 3M
Patrick Fitzgerald BL
Barrister-at-Law, Law Library
Enda Feeney
Senior Marketing Executive, Shimmer Sensing

Price

Early Bird Rate: €395 + VAT (LIMITED OFFER)

Full rate €495 + VAT

Please note the early bird discount can close sooner than expected once a certain number of seats fill up, therefore your prompt booking is strongly advised to avoid disappointment

Discounts available for bookings of 3 or more.