An in-depth look at COA/eCOA strategies and tools, including regulatory aspects of its successful implementation. Topics covered during the course will highlight the importance of PRO measurement.
This will include considerations for leveraging wearables for new endpoints as well as regulatory thinking on BYOD to provide valuable clinical endpoints for use in labeling and regulatory decision making.
This interactive course is recommended for those who have experience in clinical trials and wish to develop their skills on how PRO measurement is best implemented.
Personal Invitations from trainers
Best practices and implementation considerations
Regulatory thinking on BYOD
Leveraging wearables for endpoints
Regulatory thinking on the use of wearables to support labeling claims
All delegates will receive the book by Bill Byrom & Willie Muehlhausen
Key Takeaways & Special features
Top innovation experts will share their recommendations & best practices
All delegates will receive comprehensive course documentation
Certificate of Attendance issued by the trainers
12H+ of Intensive Learning
5H+ of Networking with other industry experts
Hands-on Case Studies & practical examples
Interactive learning approaches
A history of ePRO
Understanding of the scientific aspects of ePRO
Complexity of ePRO implementation
Regulatory aspects of ePRO implementation
Decision support for technology and vendor selection
Wearable device strategy for novel endpoint development