Global Certificate: UK Biotech Compliance Essentials
-- ViewingNowThe Global Certificate: UK Biotech Compliance Essentials is a vital course for professionals seeking to understand and navigate the complex regulatory landscape of the UK biotechnology industry. This certification, offered by a reputable institution, covers essential compliance areas, including clinical trials, pharmacovigilance, and data privacy.
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⢠UK Regulatory Framework: Understanding the legal and regulatory context of the UK biotech industry, including key agencies such as the MHRA and HFEA.
⢠Good Laboratory Practice (GLP): Learning the principles and guidelines for planning, performing, monitoring, recording, reporting, and archiving laboratory studies in the biotech sector.
⢠Good Clinical Practice (GCP): Exploring the international ethical, scientific, and practical standards for designing, conducting, recording, and reporting clinical trials involving human subjects.
⢠Good Manufacturing Practice (GMP): Examining the quality assurance principles for the production of pharmaceutical products, including the manufacture and testing of APIs and finished products.
⢠Quality Management Systems (QMS): Investigating the principles and tools for managing quality in biotech organizations, including ISO 13485 and ISO 9001.
⢠Data Integrity: Understanding the importance of data integrity in biotech compliance, including best practices for data governance, validation, and security.
⢠Pharmacovigilance: Learning the principles and practices for monitoring, assessing, understanding, and preventing adverse effects or any other drug-related problem.
⢠Clinical Trial Authorization (CTA) and Investigational Medicinal Product (IMP) Dossier Preparation: Mastering the process and requirements for obtaining authorization to conduct clinical trials in the UK.
⢠Brexit and its Impact on UK Biotech Compliance: Exploring the implications of Brexit for UK biotech compliance, including the potential changes to regulations, standards, and market access.
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