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The workshop involves a limited number of participants (30-40) and includes distinguished cardiologists, clinical trialists, principal investigators and statisticians from academia as well as senior R&D pharma doctors and NIH, EMEA-CPMP and FDA doctors.
The objectives are : Producing relevant data from controlled clinical trials that will contribute to better clinical care and to understanding the problems associated with making decisions about constitues relevant information, how to imrpove clinical trials, and, as is commonly the case, how to satisfy regulatory authorities. This will hopefully culminate in an international exchange of ideas – and perhaps innovative thought leadership (not creation of guidelines nor rule making).
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