• Focusing On: Data – Privacy – Data Sharing – AI – Wearables and Smart Devices – The future of clinical trials and health research

A one-day conference

Live Virtual Event 

Date: 16th September 2021

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.

Book your place now!

CPD Certified

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.

Full Day Programme 

Opening Remarks & Conference Chair

Donald Hickey, MDes(RCA) BABAI HDipSci DipAF(ACCA), dabl Clinical Trials

Innovation in Clinical Trials

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

  • Upcoming changes and the implementation of the Clinical Trial regulation 536/2014
  • Complex trial designs
  • Risk based quality management in clinical trials
COVID-19 – Clinical Trials in the intensive care unit during the Pandemic. Rethinking our practices. 

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

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

 

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

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

  • 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?
GDPR in Clinical Trials & Health Research – Smart Devices

Hugh Jones, EMEA Data Protection Manager, 3M

  • 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 DataAudit & Inspection
Research and Ethics – Details of the National Research Ethics committee – Public, Patient involvement (PPI)

Mary Kirwan, Barrister & Lecturer @ RCSI

  • 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
Informed Consent Process, E-Consent & Documentation

Patrick Fitzgerald, Barrister-at-Law, Law Library

  • 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
Clinical Trials in Irish Primary Care

Dr Patrick Murphy, Network Manager of the HRB Primary Care Clinical Trials Network Ireland (CTNI)

  • An overview of the HRB Primary Care CTNI
  • Research capacity development in Irish primary care
  • Integrating primary care research into the national research infrastructure

 

Using Wearables and Smart Devices in Clinical Trials

Enda Feeney, Senior Marketing Executive, Shimmer Sensing

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

Dr Patrick Murphy Dr Patrick Murphy

Network Manager of the HRB Primary Care Clinical Trials Network Ireland

Dr Patrick Murphy joined the HRB Primary Care CTNI as Development Manager in November 2019.

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A Chartered Health Psychologist with the Psychological Society of Ireland, Patrick has previously worked as an Assistant Professor in Psychology in the Disciplines of Occupational Therapy and Radiation Therapy, Trinity College Dublin, and as a postdoctoral researcher with the Health Behaviour Change Research Group in the School of Psychology, NUI Galway.

He completed his PhD in the Research Centre for Psychological Health in Trinity College Dublin in 2015. His research interests include the illness and treatment experiences of patients with chronic illnesses, the development and evaluation of complex behavioural interventions, and the use of qualitative research in clinical trials

Derick MitchellDerick Mitchell

IPPOSI CHIEF EXECUTIVE

Derick Mitchell, PhD is the Chief Executive Officer of IPPOSI. Derick has a background in research, strategy and advocacy from over 12 years’ experience spanning a number of leadership roles in research and multi-stakeholder engagement in Ireland and at the EU-level.

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Derick is an elected board member of the European Patients Academy (EUPATI) Foundation, a global initiative which is training patients to become involved in the medicines R&D process, and has spread the IPPOSI public-private partnership model to over 20 countries.

Derick serves on the advisory boards and steering committees of a number of health-related initiatives including Health Innovation Hub Ireland, DataSavesLives.eu, EHealth Ireland, a number of HIQA Advisory committees, UCD Research Ethics Committee, as well as the Medical & Life Sciences Committee of the Royal Irish Academy.

Derick is chairperson of the Scientific Advisory Board of the HRB-Trials Methodology Research Network (HRB-TMRN) and a member of the Governance committee of the Precision Oncology Ireland research consortium.

Derick holds a Bachelor of Science degree in Biotechnology from NUI Galway and a PhD in Molecular Medicine from University College Dublin.

Hugh Jones Hugh Jones

Data Protection Manager at 3M

Hugh is an experienced project manager, and works with a number of sporting, not-for-profit and membership administration organisations to help them resolve their fund-raising and regulatory challenges.

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As a certified practitioner, Hugh also supports organisations striving to achieve and maintain compliance with Irish and European Data Protection legislation. He facilitates projects to design and deploy appropriate data management policies and procedures in relation to data privacy, data quality and records retention, and conducts regular on-site assessments and process evaluations on behalf of his clients.

Mary Kirwan Mary Kirwan

Barrister & Lecturer @ RCSI

Mary is a barrister and lecturer at the Royal College of Surgeons in Ireland. She teaches medical law on the undergraduate and postgraduate Ethics programme in the RCSI.

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She is a dissertation director for the MSc Healthcare Ethics and Law course and provides training seminars in hospitals on medico/legal issues.

Mary Kirwan is a graduate of the National University of Ireland Galway and the Honorable Society of Kings Inns.

Mary is also a winner of the Law Society of Ireland Justice Media Award for her writing on current legal topics. She has written extensively in the area of law, including a weekly legal column in the Irish Independent, and is a frequent legal contributor in national and local broadcast media, including RTE’s Prime Time.

Mary is currently a member of a number of committees including a Research Ethics Committee, an Ethics Committee and an Advisory Panel.

Mary provides expert legal advice to various organisations on a voluntary basis and previously worked with the Legal Aid Board.

Patrick Fitzgerald Patrick Fitzgerald

Data Protection Manager at 3M

Patrick Fitzgerald is a graduate of UCD, the University of Cambridge and the King’s Inns.

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Between 2015-2017 he worked as a judicial assistant to Mr Justice Donal O’Donnell of the Irish Supreme Court. He has also worked in the US Federal Courts in Los Angeles, interning for Judge Beverly Reid O’Connell and Judge Philip Gutierrez in 2014. Patrick commenced practice at the Irish Bar in 2018 and practises mainly in the areas of commercial law, healthcare law and public law.

Donald Hickey Donald Hickey

MDes(RCA) BABAI HDipSci DipAF(ACCA)

A strong business development professional with a mix of experience and qualifications.

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Donald brings more than 25 years of international executive experience and a deep understanding of business to his role leading business development at dabl Ltd, the market leading software system for the collection and analysis of blood pressure in clinical trials.

Qualifications include an MDes(RCA) in Industrial Design from the RCA (London), a BABAI (Engineering) from TCD, a HDipSci (Computing) from NCI and a DipAF from ACCA.

Enda Feeney Enda Feeney

Senior Marketing Executive, Shimmer Sensing

Enda joined the Shimmer team in October 2014. Enda’s primary role is to grow Shimmer’s presence through the company’s Digital Marketing channels.

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Enda holds a Bachelor of Business in Marketing from GMIT and obtained a Masters in E-Commerce from NUIG. Enda is also undertaking a postgraduate Diploma in International Business, in conjunction with the Irish Management Institution and UCC at present.
It was during his studies and subsequent internships that Enda gained a considerable appreciation for the impact Digital Marketing Channels can have on a Company’s overall marketing efforts and also developed a keen interest in website design from a user perspective.

Sandra Bright Sandra Bright

Clinical Assessor, HPRA (Health Products Regulatory Authority)

Sandra Completed an honours Science degree in 2005, specialising in Biochemistry and Immunology in Trinity College Dublin, Ireland.

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She also completed research PhD in Oncology and Drug Development in 2009 (relating to Chronic myeloid leukaemia, CML) in Trinity College Dublin, Ireland.
Sandra has also worked in academia research for a number of years: in the field of oncology (solid and haematological malignancies), drug design, in vitro testing, in vivo animal work

Currently a clinical assessor in the HPRA: assessing new licence applications (centralised, DCP, MRP) and variations, clinical trial application and amendments, annual safety reports (DSURs) and scientific advice (national and EU level) and an Irish representative at the EU regulatory meeting group: CTFG (Clinical Trials Facilitation and Co-ordination Group)

There will be CPD certificates awarded to attendees at this conference. Please check directly with your association or awarding body to see how many points they will award

THIS IS A FULLY VIRTUAL EVENT

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Normal Rate @ €495 + VAT.

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  • 10% discount for the third delegate booked or subsequent bookings thereafter from the same company.

You will receive the speakers PowerPoint presentations within 24 hours after the event. 

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