Research Governance of New Technologies in Research Delivery
Thursday 13th June 2024

Research Governance of New Technologies in Research Delivery


Research Governance 1

Thursday 13th June 2024

09.00pm - 12.30pm

Credentials framework hero image (1)_RSZ

The Local Clinical Research Network North Thames and its partner organisations are collaborating on a unique and timely overview of Research Governance using new technologies.

This course will support your understanding of how medical software, AI and digital technologies are currently used and plans for the future. The course will give you the confidence to use AI language in the context of clinical trials and provide you with some understanding of the barriers and the governance required to successfully manage a study. It will also provide you with the information to confidently support investigators in all the healthcare disciplines with research studies using digital technologies.

Join us on Thursday 13th June 2024 from 09.00pm to 12.30pm to learn more and ask any questions you might have.

 The event will be recorded to enable delegates to revisit the topics discussed and for those who were unable to attend on the day. The link to the recording will be made available after the event.

Research Governance 0

Watch


Agenda


13th June
1

Introduction

2

Oversight of AI and Governance

3

e-Consenting for clinical trials

4

Research Ethics and the Development of Medical Artificial Intelligence

5

BREAK

5

Electronic Trial Master File - What does the Inspector want?

6

Clinical trials of digital technologies and digitising clinical trials

7

New regulations around software as a medical device

8

Summary and close

13th June

1

Introduction

2

Oversight of AI and Governance

3

e-Consenting for clinical trials

4

Research Ethics and the Development of Medical Artificial Intelligence

5

BREAK

5

Electronic Trial Master File - What does the Inspector want?

6

Clinical trials of digital technologies and digitising clinical trials

7

New regulations around software as a medical device

8

Summary and close

Elisa Visentin

Elisa Visentin has worked in Clinical Research since 2001, g...

Declan Flanagan

Declan Flanagan has been Deputy Director of Research in Moor...

Ameet Bakhai MBBS, MD, FRCP

Ameet Bakhai is a Consultant Cardiologist and Clinical Resea...

Daniela C Narvaez MsC

Daniela Narvaez has been part of R&D Moorfields since 20...

Dr Helen Cadiou

Following an MRC funded PhD, in Genetics, part of the ‘Human...

Michael Garvey Eckett

Michael Garvey Eckett provides leadership for the coordinati...

Pearse Keane

Pearse Keane is Professor of Artificial Medical Intelligence...

Elisa Visentin has worked in Clinical Research since 2001, gaining experience in the NHS and the pharmaceutical industry in delivering and governance roles.

Currently, as the first CRN-funded Practice Development Nurse, she collaborates with the BHRUT Research and Innovation Team to integrate clinical research into colleagues' daily business.

Elisa's education includes a BSc (Hons) in Adult Nursing, a Postgraduate Diploma in Professional Research, and an MSc in Drug Development.

Next

Declan Flanagan has been Deputy Director of Research in Moorfields Eye Hospital since 2020. His particular interest is in strengthening and further developing a robust effective research governance structure in Moorfields. He leads a group of 4 research governance specialists. This research governance team sees its role as advising and facilitating research teams from grant application through to dissemination of outcomes. This can only be achieved by ensuring a safe environment for patients and staff while maintaining regulatory compliance.

Declan is a consultant ophthalmologist with a subspecialty interest in medical retinal conditions. He was initially a consultant in Addenbrooke’s and Hinchingbrooke hospitals in Cambridgeshire before moving to Moorfields in 2004. He later served as Medical Director of Moorfields from 2010 to 2018 before becoming Vice President of the Royal College of Ophthalmologists from 2019 to 2022.

Previous Next

Ameet Bakhai is a Consultant Cardiologist and Clinical Research Director at the Royal Free London NHS Trust UK, a Harvard Scholar, and a Fellow of the Royal College of Physicians.

He has enabled innovation of drugs, devices and diagnostics in multiple cardiac areas of heart failure, atrial fibrillation, acute coronary syndromes, lipid and blood pressure management and risk factor reduction and prediction for cardiovascular events.

He is a founder of 2 companies, author and has published over 100 papers and received a national award for a decade of work in clinical cardiovascular research from the Royal College of Physicians and is a recognised key opinion leader for Pharma, Device, Medtech, AI, Clinical Trials and Medical Education companies.

He’s in the leadership team of the UK Research and Development directors' group since its inception, a previous fellow of the faculty of clinical informatics and the 1st Chief Research Informatics Officer for the Royal Free London NHS Foundation Trust.

Previous Next

Daniela Narvaez has been part of R&D Moorfields since 2015. Appointed as Research Governance Manager since 2022. She is a resourceful professional, committed to supporting the development of innovative research trials and improve patient outcomes.

With a background in healthcare, data analysis and extensive experience in research administration.  She has worked closely with researchers, ethics committees, and regulatory authorities to ensure that all research projects are conducted ethically, safely, and in accordance with current standards and guidelines.

Daniela started her career at the United Nations (2008) supporting the development of papers around macroeconomic indicators and public policies. Daniela obtained her first master’s degree in international public law before serving as the Director of the Research Department of Strategic Sectors for the Ecuadorian government from 2010 to 2013 when she moved to the UK to pursue her second master’s degree at Queen Marys University of London.

Previous Next

Following an MRC funded PhD, in Genetics, part of the ‘Human Genome projects’ in UCL, I completed a postdoc on Melanoma with Cancer Research UK in St Thomas. Followed a few years where I worked for Homerton Hospital as an Embryologist in the IVF Unit and then taught German for 2 years in a Secondary School. I then started to work for R&D Departments in a few Trusts, at a time where the MHRA were starting their GCP inspections. I started working in UCL R&D in 2009 in my current post, Head of QA. 

Clinical Trials are highly regulated and the Department of Health is inspecting on a regular basis. I have been through over 30 MHRA GCP inspections (site/sponsor/CRF/CTU) and a few FDA inspections. By the time you will be reading this, I would have gone through 2 MHRA inspections, plus one FDA inspection in 2024 alone. The reason I became involved with inspections is that this a way to learn how to best run trials. I am hoping to improve my understanding with each inspection.

Previous Next

Michael Garvey Eckett provides leadership for the coordination, management and set up of research involving NHS clinical informatics, data and AI across Barts Health NHS Trust and Queen Mary University of London. Michael previously worked within the CRN South London Business Intelligence team for eight years creating digital tools and analysing data to support clinical research performance management decisions. He can often be found looking at a spreadsheet.

Previous Next

Pearse Keane is Professor of Artificial Medical Intelligence at UCL Institute of Ophthalmology, and a consultant ophthalmologist at Moorfields Eye Hospital, London. Since 2020, he has been funded by UK Research & Innovation (UKRI) as a Future Leaders Fellow, and in 2023 he became a National Institute for Health Research (NIHR) Senior Investigator. He is originally from Ireland and received his medical degree from University College Dublin (UCD), graduating in 2002.

In 2016, he initiated a collaboration between Moorfields Eye Hospital and Google DeepMind, with the aim of developing artificial intelligence (AI) algorithms for the earlier detection and treatment of retinal disease. In August 2018, the first results of this collaboration were published in the journal, Nature Medicine. In May 2020, he jointly led work, again published in Nature Medicine, to develop an early warning system for age-related macular degeneration (AMD), by far the commonest cause of blindness in many countries. In 2023, he led the development of RETFound, the first foundation model in ophthalmology, published in Nature and made available open source.

Previous

For additional information about the event please contact us via email at: nihr@claritybt.com

For technical queries regarding the event, please contact our administrators:

Hannah Stones
Clarity - 4th Floor Churchgate House,
Manchester, M1 6EU
Phone: 0333 014 6074
Email: NIHR@claritybt.com

We look forward to your participation in this exciting event!

We look forward to your participation in this exciting event!