Webinar Includes: All the training handouts, a certificate, Q/A, and 60 minutes of the live webinar.
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
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 requirement
Note: CD will be dispatched 72 hours after the webinar has finished.
CEO & President ,
Regulatory Heights Inc.
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national 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 like Canada, USA, EU, China, Japan, Australia and New Zealand.
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
- 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)