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

Rachelle D'Souza is Keynote Speaker at ComplianceKey.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 articles and webinars on the latest international regulato........


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

Who can Benefit:

Webinar Id: LSHCRD001

Training Options:

Duration: 60 mins

 Stop, pause, and rewind: learn at your own place.

No reviews yet!!
 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

Refund Policy
Past Webinar of Rachelle DSouza
Use of Electronic Health Recor....
Presenter: Rachelle DSouza
View it anytime
Price: $167
FDA Regulation, 3D Printing an....
Presenter: Rachelle DSouza
View it anytime
Price: $167

More Webinar

Past Webinar: Life Sciences and Healthcare
COVID19 and Telehealth: Clarif....
Presenter: Coy Murchison
View it anytime
Price: $179
HIPAA and COVID19 - Do's and D....
Presenter: Brian L Tuttle
View it anytime
Price: $189

More Webinar

Insert title here
Pay Pal Logo   PayPal Verified Logo   GoDaddy Certified
Copyright © 2020 Compliance Key . All Rights Reserved. Back to Top