Global Certificate in Drug Regulation & Compliance

Name: Global Certificate in Drug Regulation & Compliance
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The Global Certificate in Drug Regulation & Compliance is a comprehensive course designed to meet the growing industry demand for professionals with expertise in drug regulation. This course provides learners with a solid understanding of the complex regulatory landscape, quality assurance, and compliance requirements for pharmaceuticals.

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AboutThisCourse

It is essential for those seeking to advance their careers in regulatory affairs, quality assurance, and compliance in the pharmaceutical industry. Learners will gain essential skills in interpreting and applying regulatory guidelines, ensuring compliance with regulatory requirements, and managing regulatory affairs in a global context. The course covers key topics such as global regulatory strategies, pharmacovigilance, clinical trials regulation, and quality management systems. By completing this course, learners will be equipped with the knowledge and skills necessary to navigate the complex regulatory landscape, ensuring compliance and driving success in their careers and organizations.

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CourseDetails

• Introduction to Drug Regulation: Overview of global regulatory bodies, regulations, and guidelines
• Pharmaceutical Quality Systems: Quality assurance, quality control, and GMPs
• Drug Development & Clinical Trials: Phases, design, conduct, and reporting
• Pharmacovigilance & Safety Monitoring: Adverse event reporting, signal detection, and risk management
• Regulatory Affairs: Regulatory strategy, submissions, and approvals
• Labeling & Packaging Compliance: Content, format, and language requirements
• Marketing Authorization & Lifecycle Management: Variations, renewals, and withdrawal
• Global Regulatory Intelligence: Regulatory updates, trends, and harmonization
• Inspection Readiness & Quality Management: Preparation, response, and continuous improvement

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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ComplementaryFormalQualifications

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FastTrack GBP £140

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AcceleratedLearningPath

ThreeFourHoursPerWeek
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StandardMode GBP £90

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FlexibleLearningPace

TwoThreeHoursPerWeek
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GLOBAL CERTIFICATE IN DRUG REGULATION & COMPLIANCE

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London School of International Business (LSIB)

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05 May 2025

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