Orphan Drugs Clinical Trials

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

EMA and FDA expectations for Orphan Drugs clinical studies

The Importance of avoiding Bias and Regression to the Mean

Working with Evidence Based Medicine and Clinical trials

How to design a study and which methodology to use?

Practical implementation of regulatory pathways

Where do we need randomised trials?

KEY TOPICS

Orphan Drugs EU and US regulatory guidance

Legal basis for approvals (Regulatory pathways) & Working Groups

Trial concept, design and conclusions

TRAINER

Dr. Simon Day

Clinical Trials Consulting & Training,

Simon has spent 30 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 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 particularly well known for his work in the area of developing treatments for rare diseases. Simon has served on a variety of data monitoring committees both for industry-sponsored and government-sponsored 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, including courses at the FDA on the development and regulatory assessment of orphan drugs.

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