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March 19: OHDSI: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data

March 19 @ 1:00 pm - 5:00 pm

Topic: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data

The purpose of this public workshop is to obtain input from stakeholders on considerations for development and submission of proposed draft guidance relating to patient experience data submitted by an external stakeholder, including:

  1. Defining the scope of the proposed draft guidance
  2. Developing the proposed draft guidance
  3. Submitting the proposed draft guidance to the FDA

Date: Monday, March 19, 2018, 1:00-2:00 p.m. ET

Location:  
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus)

Registration:
Register here

Registration to attend in person will close on March 12, 2018.

If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the workshop will be based on space availability.

Details

Date:
March 19
Time:
1:00 pm - 5:00 pm

Citation:

March 19: OHDSI: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data: March 19: OHDSI: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/event/march-19-ohdsi-fda-workshop-developing-submitting-proposed-draft-guidance-on-patient-experience-data/. Updated February 28, 2018.