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Key deadlines

Conference starts:

2017-05-08

Website

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Conference Description

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)

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com