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


Rachelle D'Souza is Keynote Speaker at Compliance key Inc.She is licensed various medical and consumer products and facilities for start-ups and multi-national 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.
At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her articl....

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 products.

Why should you attend this webinar?

Did you know that electronic health record (EHR) can be used in prospective clinical investigations of human drugs, biologics, medical devices and combination products regulated by the US Food and Drug Administration (FDA)? This includes foreign studies used in support of an application for marketing approval of the medical product.
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:

FDA Recommendations on

  • 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
  • Ensuring the quality and integrity of EHR data that are collected and used as electronic source data in clinical investigations
  • Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA's inspection, record keeping and record retention requirements

Who can Benefit:

  • Sponsors of clinical trials (drug, biologic, medical device & combination product manufacturers)
  • Clinical Investigators (physicians)
  • Contract Research Organizations (CROs)
  • Institutional Review Boards (IRB) / Ethics Review Boards (ERB) / Research Ethics Boards (REB)



Webinar Id: LSHCRD001

Training Options:

Duration: 60 mins

 06/30/2017

 10:00 AM PST | 01:00 PM EST

 Single Attendee: [Only for one participant]

 $179 (Live)                    $304 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

 $363 (Live)                    $488 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

 $726 (Live)                    $945 (Live + Recorded)

 Recorded: [Six month unlimited access]

 $217(Single Attendee)  $599 (Unlimited Attendee)

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