Data Monitoring Committees

Place
London, UK
Site visit
Dates
11 – 12 June 2020
Who should attend?

Clinical Research Associates • Clinical Operations Analysts • Pharmacovigilance Managers & Scientists • Regulatory Managers and Specialists • Statisticians • Drug Product Development Scientists

Summary

This 2-day course will focus on practical issues around the workings of Data Monitoring Committees (DMCs) including a review of group sequential methods and FDA and CMHP guidance on DMCs. Throughout the course, mock DMC sessions will be convened where various scenarios will be considered and discussed, and decisions have to be made.

The course is relevant to all those who need to set up DMCs and work with them throughout the course of a clinical trial. It is also relevant to those who may serve as members of DMCs.

Learning Objectives

  • DMC motivating examples, formal interim analyses, safety monitoring
  • Understand composition and responsibilities of DMCs
  • Gain an overview of group sequential methods
  • Explore DMCs regulatory guidance (CHMP, FDA, WHO, NIH)
  • Learn what regulators might and might not do (and when)
  • Take part in mock DMC sessions & try different scenarios

Key Topics

  • Introduction to DMCs (examples, formal interim analyses, safety monitoring)
  • Overview of group sequential methods
  • The roles of a DMC other than ‘stop/continue’ decisions
  • Regulatory guidance (CHMP, FDA, WHO, NIH)
  • Composition and Responsibilities of DMCs
  • How do DMC meetings run?
  • Interactive simulation of a DMC meeting

Programme

  • Training materials printed and digital
  • All delegates will receive printed and LinkedIn certificates
  • 5+ hours of networking with industry peers
  • Networking reception

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Trainers

Simon Day PhD.

CEO

Clinical Trials Consulting & Training

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry, but also including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). This included working on the CHMP Efficacy Working Party during the development of the European guidance on DMCs. He specialises in training and consulting on drug development programmes, scientific advice/end of Phase II meetings and preparations for oral explanations and advisory committees. He is a former president of the International Society for Clinical Biostatistics. In 2012 he was elected a Fellow of the Society for Clinical Trials. He has published widely in statistical and medical journals, is author of one book “Dictionary for Clinical Trials” and is joint editor of the “Textbook of Clinical Trials”, both published by Wiley. Simon has served on a variety of data monitoring committees both for industry- and governmentsponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He formerly served as vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world. Simon has served on a number of DMCs for small and large companies as well as for government-sponsored trials.

Simon Day PhD.

CEO

Clinical Trials Consulting & Training

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry, but also including five years heading the statistics unit at the UK regulatory authority (the Medicines and Healthcare products Regulatory Agency). This included working on the CHMP Efficacy Working Party during the development of the European guidance on DMCs. He specialises in training and consulting on drug development programmes, scientific advice/end of Phase II meetings and preparations for oral explanations and advisory committees. He is a former president of the International Society for Clinical Biostatistics. In 2012 he was elected a Fellow of the Society for Clinical Trials. He has published widely in statistical and medical journals, is author of one book “Dictionary for Clinical Trials” and is joint editor of the “Textbook of Clinical Trials”, both published by Wiley. Simon has served on a variety of data monitoring committees both for industry- and governmentsponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He formerly served as vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world. Simon has served on a number of DMCs for small and large companies as well as for government-sponsored trials.

Tour info

Testimonial

Price per Delegate (EUR)

2198.00
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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543