Professional Certificate in Pharma Regulatory Compliance: Legal Standards
-- ViewingNowThe Professional Certificate in Pharma Regulatory Compliance: Legal Standards is a crucial course for professionals seeking to excel in the pharmaceutical industry. This program focuses on the legal frameworks and regulatory standards that govern pharma operations, ensuring that learners gain a deep understanding of the compliances needed to succeed in this field.
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โข Introduction to Pharma Regulatory Compliance: Understanding the legal landscape, key players, and regulations in pharmaceutical compliance
โข Legal Standards for Drug Development: Exploring the regulations and guidelines for drug development, including FDA, EMA, and ICH standards
โข Clinical Trials Compliance: Legal requirements for conducting clinical trials, including informed consent, data integrity, and adverse event reporting
โข Labeling and Packaging Compliance: Legal standards for drug labeling, packaging, and promotion, including FDA regulations and guidelines
โข Good Manufacturing Practices (GMPs): Legal requirements for manufacturing processes, quality control, and documentation
โข Pharmacovigilance and Adverse Event Reporting: Legal standards for monitoring drug safety, reporting adverse events, and pharmacovigilance systems
โข Drug Supply Chain Security Act (DSCSA): Understanding the legal requirements for drug supply chain security, tracking, and tracing
โข Import and Export Regulations: Legal standards for importing and exporting drugs, including customs regulations and international conventions
โข Compliance Risk Management: Developing a risk-based approach to compliance, including monitoring, auditing, and corrective action
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