Executive Development: UK Biotech Regulatory Practices
-- ViewingNowThe Executive Development: UK Biotech Regulatory Practices certificate course is a comprehensive programme designed to provide learners with a deep understanding of the regulatory landscape in the UK biotech industry. This course is crucial for professionals seeking to navigate the complex regulatory frameworks and accelerate their career progression in this field.
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⢠UK Biotech Regulatory Framework: Overview of the legal and regulatory context governing biotechnology in the UK, including key agencies and legislation such as the Human Tissue Act, Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA).
⢠Clinical Trials and Ethics: Examination of the ethical principles and regulatory requirements for conducting clinical trials in the UK, including the role of Research Ethics Committees (RECs) and the EU Clinical Trials Directive.
⢠Pharmacovigilance and Safety Monitoring: Exploration of the processes and procedures for monitoring and reporting adverse effects of biotech products, including pharmacovigilance systems and risk management strategies.
⢠Quality Management and Good Manufacturing Practices: Overview of the principles and practices for ensuring the quality and safety of biotech products, including the use of quality management systems and compliance with Good Manufacturing Practices (GMP).
⢠Regulatory Strategy and Submissions: Development of a regulatory strategy for biotech products, including the preparation and submission of regulatory applications, and communication with regulatory agencies.
⢠Regulatory Affairs in Product Development: Examination of the role of regulatory affairs in the product development process, including planning and coordinating regulatory activities and interactions with regulatory agencies.
⢠Regulatory Intelligence and Horizon Scanning: Overview of the importance of monitoring and understanding regulatory developments and trends, and their impact on biotech products and companies.
⢠Post-Marketing Regulatory Activities: Exploration of the regulatory requirements and activities for biotech products after market authorization, including post-marketing surveillance and lifecycle management.
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