Event

Good Clinical Practices Compliance

March 20, 2012 iCal

Time: 12:00-2:00pm
Location: LIVE, INTERACTIVE TRAINING WEBINAR; IN YOUR OFFICE

Clinical trails are costly from both a resource and financial perspective with company reputations and survivals often resting on a single phase three trial for its lead product candidate

This live training webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance. This will result in trials running smoothly, data being valid and giving your drug the best chance of success in the clinic leading to as early an approval as is possible. This webinar describes the major systems that must be in place, in order to meet the requirements. It will describe ways that you can assess if you have the correct systems and whether they are designed appropriately and equally importantly whether they are being executed as expected. Major pitfalls that companies run into will be described with how you can tell if you are vulnerable and how to fix the problems, including setting up systems people will follow. Since most companies use CRO’s for some, if not all, trial management, the webinar describes the oversight that is necessary to assure you are getting what you contracted for including at your USA and ex-USA sites.

Learning Benefits:

This webinar will provide valuable assistance to all companies that conduct clinical trials both using internal resources as well as those that outsource the function to CRO's in pharmaceutical and biotech industries.

-What systems must be in place and how to assess if yours meet the requirements.

-How to assess whether your systems are being followed and how to improve compliance.

-What are the common pitfalls and how to avoid or correct them.

-How to use your auditing program to fix problems not just to identify them

-How much resource you should commit to monitoring and auditing even if you outsource the trial to a CRO.

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