This month DCS is happy to present:
“Minimizing
the Impact of FDA's Drug Induced Liver Injury Guidance on All Preapproval
Clinical Trials.”
In July 2009, the
FDA’s CDER and CBER issued the "Drug Induced Liver Injury Premarketing
Clinical Evaluation" guidance that potentially requires a large increase
in data captured in all clinical trials on unapproved drugs. Drug Induced Liver Injury (DILI) is severe
liver damage potentially induced by a drug and occurs in about 1 in 10,000
clinical trial subjects. It is
unpredictable and all subjects must be monitored. Some of the required data are
collected in most trials, but some are not, such as time of study medication. This
webinar reviews the key parts of the guidance and the additional data required,
and suggests data capture approaches to minimize the impact on sites and
sponsors. It also helps to evaluate the risks of different approaches rather
than assuming that all data are required for all subjects.
Pricing-- $299 for one individual
- $849 for one institution (up to 3 log-ins, unlimited number of
people