FDA current recommendations on using electronic health records - 2017
This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product.
Why should you Attend:
This training provides FDA's current recommendations on this topic. Check out the specific areas covered below. If you are a sponsor of a clinical trial involving a drug, biologic, medical device or combination product, a clinical investigator, a contract research organization (CRO) or an institutional review board (IRB), you stand to benefit from this training.
Areas Covered in the Session:
- Whether and how to use EHRs as a source of data in clinical investigations
- Using EHRs that are interoperable with electronic systems supporting clinical investigations
Who Will Benefit:
- Institutional Review Boards (IRB)
- Ethics Review Boards (ERB)
- Research Ethics Boards (REB)
Speaker and Presenter Information
Rachelle D'Souza
CEO of Regulatory Heights Inc.
Rachelle has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.
Relevant Government Agencies
FDA
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Mon, May 8, 2017, 10:00am - 11:00am
PT
Cost
General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All