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: [email protected]