se of Electronic Health Record Data (EHR) in FDA regulated clinical investigations - By Compliance Global Inc

7 years ago Posted By : User Ref No: WURUR12673 0
  • Image
  • TypeWebinar
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  • Location New York, United States
  • Price
  • Date 05-07-2017
se of Electronic Health Record Data (EHR) in FDA regulated clinical investigations - By Compliance Global Inc, New York, United States
Webinar Title
se of Electronic Health Record Data (EHR) in FDA regulated clinical investigations - By Compliance Global Inc
Event Type
Webinar
Webinar Date
05-07-2017
Last Date for Applying
05-07-2017
Location
New York, United States
Organize and Presented By
Compliance Global Inc
Organizing/Related Departments
Online Training
Organization Type
Event Organizing Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
National
Related Industries

Education/Teaching/Training/Development

Location
New York, United States

Overview:

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.

Why Should You Attend:

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.

Areas Covered in this Webinar:

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

Learning Objectives:

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 Will 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)

Email: [email protected] 
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

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.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

Others Details

For more details and updates please visit website.

Registration Fees
Available
Registration Fees Details
Visit website.
Registration Ways
Website
Address/Venue
  Online 
Official Email ID
Contact
Compliance Global Inc

Compliance Global Inc. 2754 80th Avenue, New Hyde Park, NY 11040

[email protected]

     844-746-4244
   Fax No: 516-900-5510