Regulatory and operational insights to protect patient safety and minimize disruption

Date
Time 10:00 - 11:00
Location Webinar
Timezone America/New_York

Overview

We are living in unprecedented times.  Since the outbreak of COVID-19, there has been disruption to clinical trial management.  Patient non-attendance for assessments, laboratory tests not being submitted and site closures all pose risks to the integrity of trial data and it is expected that these challenges will impact trials for at least four to five months.

Sponsors are both ethically and economically obliged to continue ongoing trials, and ensuring that decisions around protocol revisions and other trial adjustments are properly captured and documented is essential to the scientific integrity of the trial.

In this webinar, industry experts present regulatory and operational insights to enable you to be proactive to protect patient safety and minimise disruption.

  • Summary of regulatory considerations resulting from COVID-19
  • Overarching regulatory principles and risk management
  • Operational approaches and considerations to maintain momentum and compliance
  • Case studies: Examples of how you can respond to specific challenges

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Presenters

Andy Garrett

Executive Vice President, Scientific Operations, Clinical Research Services, ICON plc.

Andrew Garrett is responsible for strategic direction and operational execution of ICON’s Global Scientific Operations. He was Chair and founder of the Royal Statistical Society’s Data Science Section having previously been VP/Honorary Secretary of the RSS, and Chair of its Long Term Strategy Group.  He was previously a Board member of the UK’s Administrative Data Research Network and is currently a member of UKSA’s Research Accreditation Panel that oversees the approval of research projects in accordance with the Digital Economy Act 2018.  Andy has a BSc in Economics, an MSc in Medical Statistics and a PhD in Applied Statistics. He has worked extensively in the area of rare diseases and has a portfolio of published papers on the topics of non-inferiority trials, subgroup analysis, data transparency and modelling and simulation.

Rose Kidd

Senior Vice President, Clinical Operations, Clinical Research Services, ICON plc.

Rose Kidd has 29 years experience in the clinical research industry and leads Global Clinical Operations at ICON. Throughout her career, Rose has undertaken a variety of leadership roles in clinical delivery and has partnered with large and mid size biopharma companies. Rose has been fortunate to see the development of drugs enhance and improve the quality of lives of patients throughout the globe across a range of therapeutic areas and spent a large part of her career working in the area of HIV.  Prior to joining ICON, Rose worked with Glaxo Smithkline in the United Kingdom in the field of pre clinical and drug formulation.

Rose has a National Diploma in Food Science, a BSc (Hons) Pharmacology and in 2015 Rose completed a diploma in strategy, innovation and change management with UCD as she has a keen interest creating innovative solutions that yield significant timeline and financial improvements to both ICON and the industry in general.