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Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
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
Overview of the webinar
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 products.
Who should attend?
- CRO Management within Clinical Research
- CEOs
- Any Management Level
- COOs
- Chief Product Officer
- Regulatory Directors
- VP within Management
- Drug Product Executives
- Medical Device Executives
- President
- CoFounder within CRO
- Director within CRO
- Manager within CRO
- Innovative Startups
- Clinical CROs
- Study Managers
- Study Recruiters
- Manufacturers for Drug Products
- Manufacturers for Medical Devices
- Include all levels from Managers to CEO, Owners, Founders, CoFounders, Clinical Trial Associates
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. 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.
Faculty - Ms.Rachelle D’Souza
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.