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)
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.
Compliance4All DBA NetZealous,
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501271LIVE?channel=ticketprinting_May_2017_SEO