Advanced Certificate in PharmaTech Clinical Trial Regulations
-- ViewingNowThe Advanced Certificate in PharmaTech Clinical Trial Regulations is a comprehensive course designed to provide learners with in-depth knowledge of the regulations and compliance requirements in clinical trials. This course is essential for professionals seeking to advance their careers in the pharmaceutical industry, as it covers critical topics such as GCP, ICH, and FDA guidelines.
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โข Clinical Trial Regulations Overview: Understanding global clinical trial regulations, ICH-GCP guidelines, and the role of FDA in regulating clinical trials in the US.
โข Investigational New Drug (IND): The IND application process, requirements, and amendments, including pre-IND meetings and IND annual reports.
โข Institutional Review Boards (IRBs): IRB composition, functions, operations, and review process for protecting human subjects.
โข Informed Consent: Components of informed consent, documentation, and best practices to ensure patient understanding and compliance.
โข Adverse Event Reporting: Identifying, reporting, and documenting adverse events, serious adverse events, and suspected unexpected serious adverse reactions (SUSARs).
โข Data Management in Clinical Trials: Electronic data capture, data validation, data monitoring, and data reporting in compliance with regulatory requirements.
โข Clinical Trial Monitoring: Monitoring plans, on-site monitoring, and remote monitoring for ensuring trial integrity and compliance.
โข Clinical Trial Audits and Inspections: Preparing for and managing audits and inspections by regulatory authorities, including FDA, EMA, and others.
โข Clinical Trial Closeout: Final study report, archiving, and transfer of clinical trial data and materials in compliance with regulations.
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