Executive Development Programme in Biotech Regulatory Affairs and Compliance

Name: Executive Development Programme in Biotech Regulatory Affairs and Compliance
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The Executive Development Programme in Biotech Regulatory Affairs and Compliance is a certificate course designed to provide learners with critical skills in regulatory affairs and compliance for the biotech industry. This programme is essential for professionals seeking to advance their careers in this rapidly evolving field.

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AboutThisCourse

With increasing demand for biotech products and therapies, there is a growing need for experts who can navigate the complex regulatory landscape and ensure compliance with laws and regulations. This course equips learners with the knowledge and skills to succeed in this role, covering topics such as regulatory strategy, clinical trials, product approval, and post-market surveillance. Through interactive lectures, case studies, and hands-on exercises, learners will gain practical experience in managing regulatory affairs and compliance for biotech products. By completing this programme, learners will be well-positioned to advance their careers and make meaningful contributions to the biotech industry.

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CourseDetails

• Biotech Regulatory Affairs Overview
• International Regulatory Landscape for Biotechnology
• Regulatory Strategy for Biotech Products
• Biotech Product Development and Clinical Trials Regulation
• Quality Systems and Current Good Manufacturing Practices (CGMPs)
• Pharmacovigilance and Adverse Event Reporting in Biotech
• Biotech Intellectual Property Protection and Data Exclusivity
• Biotech Labeling, Advertising, and Promotion Compliance
• Biotech Regulatory Inspections and Audits Preparation
• Global Regulatory Harmonization and Collaboration Initiatives

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

NoPriorQualifications

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CourseProvidesPractical

NotAccreditedRecognized
NotRegulatedAuthorized
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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EXECUTIVE DEVELOPMENT PROGRAMME IN BIOTECH REGULATORY AFFAIRS AND COMPLIANCE

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London School of International Business (LSIB)

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05 May 2025

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