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CRO GCP Compliance Failure - What Are The Sponsors Options?
Thursday, January 31, 2013 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
This webinar will use a case study-approach to explain the causes for a CRO failure and what a sponsor can do to address the failure and work towards achieving a successful outcome.
Why Should You Attend:
The regulatory agencies frequently reject pharma sponsor market approval applications due to CRO failure. The CRO keeps the sponsor’s money and the sponsor loses its regulatory filing fees and their development costs. Sometimes sponsors incur regulatory enforcement actions. There are documented cases where pharma sponsors have had to close down as a direct result of CRO failure.
This webinar will present two anonymous case studies of CRO failure- both of which were successfully addressed by the Sponsor. One of the cases incurred an intensive FDA inspection of the investigator sites and at the sponsor location. Other cases in the public domain will be referenced to support the discussion. There are important lessons of what happened, why it happened, and what worked or did not work to achieve the successful outcome, despite the initial CRO failure. CROs are necessary for the pharma development of new products. The risk of using a CRO needs to be addressed proactively by clinical trial sponsors.
Areas Covered in the Webinar:
- How the sponsor may have enabled the CRO compliance failure
- How to evaluate the CRO before you sign a contract
- The limitations of delegating sponsor regulatory obligations to a CRO
- How to monitor CRO performance
- What sponsor remediation procedures worked for these two cases
- How and when to fire your CRO and its implications on the continued program
- How and when to replace your CRO with another CRO and its implications on the continued program
- How to assure an appropriate CRO management environment that encourages a positive CRO /Sponsor relationship
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.