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Applying Good Clinical Practices (GCP) to the Conduct of Clinical Research
$159.00 — $179.00
Expected conduct in Clinical product development and application of Good Clinical Practices (GCP) are like two faces of a coin. They both must exist and successfully function in assuring product safety, efficacy, and protecting all human subjects involved whether as volunteers, clinical trial participants, clinicians, and sponsors. As product research becomes more innovative, availability of advanced sophisticated technology, and complex un-met medical needs, adherence to GCP is becoming a daunting task for everyone involved.
This webinar will provide attendees a high level overview of GCP, its applications in various real life settings such as First in Human, IND/NDA/BLA/PMA/510k filings, IRB’s, Use of automated Technology, Clinical Manufacturing, Clinician and Site responsibilities, Sponsor oversight, FDA regulations and ICH (E6) directives. Participants will gain knowledge and understanding of FDA’s regulatory expectations (force of law), IRB roles and responsibilities, Documentation practices, and ICH rules and guidelines.
This webinar will review the following not all inclusive areas and disciplines of Clinical research including trials, recruiting volunteers, and trial participants.
- Historical background in Clinical Research and GCP expectations
- Identification of applicable regulations, standards and GCP requirements
- Clinicians (PI), Resident, CRA, RN and DMC responsibilities
- Sites (single & multiple) involvement & Responsibilities
- Sponsor Obligations, Audits, and Protocol Oversight
- Use of technology, Operation of Quality Systems
- Labeling requirements (PI Brochure, CDS, Informed Consent, Source documents, Protocols)
- Complaints and reporting (AE, SAE, Progress, Final)
- Filing of IND, NDA, BLA, PMA, 510k and contracted organizations
- FDA’s inspectional program for Clinical Studies.
Who should attend:
- Clinical Research Associates (CRA’s), Trial RN’s
- Clinical Trial Material managers
- Regulatory Professionals
- Quality Professionals
- Business Process Owners (Clinical, Marketing, Research)
- GCP/GMP Auditors
- Document Control Specialists
- Subject Matter Experts
- All personnel who want to learn about FDA Inspections/expectations for Clinical Development