FDA current recommendations on using electronic health records - 2017

Overview:

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)

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

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.