data monitoring
Stability Testing

Some of the Learning Outcomes

This 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.

Benefits of In-house Trainings

Get to know the Trainer

Dr. Simon Day
Dr. Simon DayDirector at Clinical Trials Consulting & Training

Simon has spent 35 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specializes 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 particularly well known for his work in the area of developing treatments for rare diseases.

He is joint editor of Statistics in Medicine, on the editorial board of Translational Sciences of Rare Diseases, and previously joint editor of the Journal of the Royal Statistical Society; he has also served on editorial boards on a number of other journals, including Pharmaceutical Statistics, Controlled Clinical Trials and British Journal of Clinical Pharmacology. 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 a joint editor of the “Textbook of Clinical Trials,” both published by Wiley. Past responsibilities have included President of the International Society for Clinical Biostatistics, Chair of the External Advisory Panel for the Department of Statistics at Oxford University, Associate on the faculty at Johns Hopkins University in Baltimore, and vice-Chair of the West London Research Ethics Committee.

He has served on a variety of data monitoring committees both for industry- and government-sponsored trials. He has given numerous lectures and courses on statistics and clinical trials all around the world, including courses at the FDA on the development and regulatory assessment of orphan drugs.

Feel free to suggest the topics that you would like to learn about at
our Data Monitoring Committees In-House Training.

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Request detailed Agenda - Data Monitoring Committees In-House Training

Who should attend?

  • Drug Product Development scientists
  • Regulatory Managers and specialists
  • Clinical Development staff
  • Statisticians
  • Pharmacovigilance scientists
  • Clinical research associates
  • Clinical trial operations staff

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