Executing Global Clinical Trial Operations
|Event Date/Time: Sep 28, 2010||End Date/Time: Sep 29, 2010|
|Registration Date: Sep 25, 2010|
|Early Registration Date: Jul 23, 2010|
1. Best practices on how to conduct global protocols in regions with untested or developing clinical research infrastructures (eg, emerging markets).
2. How to clarify regulatory acceptance of global results for national registrations.
3. Understand epidemiological resources in non-US/EU countries to allow for clinical assessments of disease opportunities, validation of study sites/protocols, conduct of observational/pharmacoepidemiological studies in those countries.
4. Get clarification on what is acceptable with regards to safety reporting, risk evaluation and mitigation plans.
5. Tips on How to create a working environment that is flexible enough to deal with the regulatory environment.
6. Understand what sponsors can do to make the review process easier.
7. Analyze a complex and interactive case study involving several ethical problems in conducting global clinical trials.
8. Best Practices in global patient recruitment
9. Best practices in executing global trials collaboratively with the sponsors, CROs and investigators.
10. How to investigate and identify the right clinical partner to implement your global trial by different regions.
11. Lessons learned from leaders with recent hands-on experience in executing global trials.
12. Peer-to-peer information sharing on the hottest issues cultural differences, resource utilization, data mining and strategies to managing a global trial during an acquisition.
13. Analyze a complex and interactive case study involving several ethical problems in conducting global clinical trials.
14. Best practices on how to win in the contest of speed to complete recruitment vs value in data from representative populations in pivotal clinical trials.
15. Understand the pros and cons of social media and networking for global patient recruitment and the investment risks.
16. Identify the expectations of implementing a global recruitment strategy from beginning to end.
17. Informed consent simplification and improvement strategies.