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Conference Directory
Why Pharmacovigilance (Phase IV Trials) will be increasingly seen
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: california
Number of Attendees: Unknown
Webinar or Virtual Event: No
Keywords: Clinical Research Scientists, Safety Nurses, Pharmacovigilance compliance training, FDA Phase IV trials regulations, FDA post market studies compliance training
Start Date of Conference:: 11-02-2011
End Date of Conference: 11-02-2011
Description of Conference: This Phase IV Trials training will help you in understanding FDA’s mandate on Phase IV trial and best practices for successful studies that meet the complex requirements.
Why Should You Attend:
FDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines.
Areas Covered in the Seminar:
- The Nature of the I/E criteria in Phase IV studies.
- How does the Safety Monitoring Plan differ in Phase IV?
- What constitutes a “rare” adverse event?
- What are the types of Phase IV studies?
- Why large studies are needed to uncover rare Serious adverse events?
- What is the value of a DMC in large studies?
- What endpoints is the FDA looking for once they have approved a drug/device?
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 31st October 2011.
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2011 
