Professional Certificate in Drug Safety & Global Compliance
-- ViewingNowThe Professional Certificate in Drug Safety & Global Compliance is a crucial course designed to meet the growing industry demand for experts who can ensure drug safety and compliance in the pharmaceutical sector. This program equips learners with essential skills needed to navigate the complex regulatory landscape, mitigate risks, and ensure compliance in drug development and commercialization.
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⢠Introduction to Drug Safety & Global Compliance: Understanding the regulatory landscape, drug safety, and compliance requirements.
⢠Pharmacovigilance: Monitoring, assessing, and understanding the risk-benefit profile of drugs.
⢠Clinical Trials Compliance: Ensuring adherence to regulations and guidelines in clinical trial design, execution, and reporting.
⢠Good Manufacturing Practices (GMP): Ensuring compliance with GMP regulations to maintain product quality and consistency.
⢠Good Laboratory Practices (GLP): Adhering to GLP principles in laboratory studies and data management.
⢠Good Clinical Practices (GCP): Ensuring clinical trials are conducted ethically and according to regulatory standards.
⢠Quality Assurance & Control: Implementing quality systems to maintain compliance and improve drug safety.
⢠Regulatory Affairs & Submissions: Managing regulatory submissions, variations, and renewals to maintain drug approval and market access.
⢠Inspection Readiness: Preparing for and managing regulatory inspections and audits.
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