FDA current recommendations on using electronic health records – 2017Q

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations


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 Profile:
Rachelle D’Souza , CEO of Regulatory Heights Inc., 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Ad Reference ID: 97058cfb1bcbc533

Report problem

Processing your request, Please wait....

Leave a Reply