We hope you can join us for our May monthly CTD Community call!
This month is another open discussion call with several topics.
a. Interim guidance released on how to approach the protection of personal data and CCI
b. Review of transparency rules – public consultation
2. Policy 0070:
a. The Policy 0070 and Policy 0043 working groups unite!
b. EMA will host a webinar on Tuesday, May 16 regarding the restart of Policy 0070
a. In January, a US Congressional Committee sent a letter to FDA and NIH regarding non compliance on ClinicalTrials.gov. Mike Laurer posted a blog post reiterating the NIH commitment to compliance and providing compliance statistics
4. Digital Health Devices and disclosure
a. Is this a topic that we would find useful to cover in a future meeting? Does anyone have experience with these devices?
Date: Tuesday, May 9 10, 2023 at 10am EST
Join from PC, Mac, Linux, iOS or Android: https://diaglobal.zoom.us/j/816810891 - get the Zoom App to join on the go
Telephone: Dial (for higher quality, dial a number based on your current location):
US: +1 669 900 6833 or +1 646 876 9923 or +1 877 853 5257 (Toll Free) or +1 855 880 1246 (Toll Free)
International numbers available: https://zoom.us/u/b8Itm2wh4
Meeting ID: 816 810 891
Have a great week!