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: 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
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
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)
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.