Developing Best Practices for the Successful Integration of Regulatory Affairs During Study Start-Up of a Clinical Trial
- Impact of the European Medical Device Regulations on clinical investigations/evaluations.
- Considerations to be made when working with multiple sites and multiple IRBs.
- In regards to ICH guideline updates, areas that have presented the greatest challenges for conducting clinical trials. In particular, challenges seen when using real-world data sources in clinical evaluations and the submission of electronic records.
- Greater attention is being given subject participants for clinical trials; What are the best practices for CROs in recruiting the right mix of subjects and the right number?
- Data integrity is being more closely scrutinized. Hear about the steps that should be followed to ensure the proper collecting and maintaining of data to support data integrity requirements / expectations?
- Other questions as gauged by the interactive discussion with the audience
Moderator: Jason Palasota, Clinitiative
Confirmed Panelists: Alicia Hemphill, Vice President Regulatory, Oriel STAT A MATRIX; Pamela Nelson, CEO, Bracane Company
December 3rd, 2019
11:30 - 12:00 Registration
12:00 - 1:00 Presentation
1:00 - 1:30 Networking
We will be participating in the Health Wildcatters Christmas Toy Drive at this event. We ask that you bring a jump rope or soccer ball as a donation.
Special thanks to our hosts Health Wildcatters!
Thank you to the BioNTX Education Committee: Cynthia Gross, Don Hurd, Jason Palasota, and Terrina Wilder.
