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Subscribe NewsletterFDA Inspections of Clinical Data Systems
Product Id
:
600209
Overview: The field of GCP has rapidly evolved over the last 20 and particularly the last 5 years and the requirements are getting tougher.
Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This 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 approval.
Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This 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 approval.
Why Should You Attend: Failure to assure satisfactory performance in the clinical development program can result in agencies not accepting data and in extreme cases pivotal trials. Poorly executed trials can often fail to show safety or efficacy for otherwise promising drugs. These mishaps can cost companies millions of dollars and time which can cause companies to fail.
Areas Covered in the Session: This webinar will provide valuable assistance to all companies that conduct clinical trials both using internal resources and also those that outsource the function to CRO's in pharmaceutical and biotech industries. It will highlight the systems that are potentially problematic and how to fix them.
- What the major systems that must be in place - the requirements
- Ways to determine how well your systems are designed
- Ways to determine how well your systems are operating
- Major pitfalls that companies run into
- If I use a CRO, how much oversight is enough
- How do I manage sites, do I have to audit them all?
- How do I manage an ex USA site
- How can I get processes that everybody will follow.
Who Will Benefit:
- QA GCP staff
- Regulatory Affairs
- Clinical Operations
- Clinical Development
- Project Managers
- Drug Safety staff