MHRA gives an insight into new ICH S9 guidelines at Clinical Development in Oncology
JW McBlane, Clinical Assessor, MHRA will be giving an exclusive insight into the agency's views of the new ICH S9 guidelines.
- (1888PressRelease) December 15, 2010 - His case study, Early Stage Clinical Trials In Patients With Advanced Cancer - ICH S9 And Recent Regulatory Developments, is part of the 2nd Annual Clinical Development in Oncology conference, taking place in London, 15-16 March 2011.
This update will allow specialists to begin trials on the basis of reduced preclinical data sets and understand what the UK agency deems acceptable. The case study will explain how to minimize the trial time and ensure first time regulatory approval. It will also highlight the differences regarding the approach to trials in patients with advanced cancer and explain what preclinical data are essential to support initial clinical exposure. The case study will close with real-life examples based on MHRA experience.
Other related topics cover on the event will include:
-Applying Adaptive Design Principles To Oncology Trials To Speed Time To Market (Alun Bedding, Early Phase Design, GlaxoSmithKline)
-Maximising The Use Of Preclinical Data To Optimise Trial Design And Patient Selection (Gregoire Prévost, Director, Oncology Translational Research, IPSEN)
-Innovation In QT Study Design For Oncology Patients (Corina Dana Dota, MD, AstraZeneca, ECG Centre Director, CPD Co-chair Cardiac QT/Arrhythmia Safety Knowledge Group)
-Companion Diagnostics - Opportunities And Challenges (Maria Orr, AstraZeneca)
Optimising Clinical Development in Oncology is co-located with Optimising Clinical Development for CNS as a part of Clinical Trials Summit. If you want to find out more, please go to www.oncologysummit.co.uk or www.clinicalcns.co.uk.
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