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


Contact Event Organizer



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