Global Certificate in Biotech Tax & Regulatory Compliance
-- ViewingNowThe Global Certificate in Biotech Tax & Regulatory Compliance is a crucial course for professionals seeking expertise in the biotechnology industry. This certificate program, offered by a reputable institution, covers essential topics including tax strategies, regulatory affairs, and compliance issues.
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โข Global Biotech Regulatory Landscape: Overview of global biotech regulations, including FDA, EMA, and other international regulatory bodies
โข Biotech Taxation Fundamentals: Introduction to biotech taxation, including R&D tax credits, patent box regimes, and other relevant tax incentives
โข Clinical Trials Compliance: Regulatory requirements and best practices for conducting clinical trials, including ICH-GCP guidelines and data privacy regulations
โข Biotech Intellectual Property Protection: Strategies for protecting biotech IP, including patent prosecution, licensing, and trade secret protection
โข Pharmacovigilance and Safety Reporting: Obligations for monitoring and reporting adverse events and product safety issues, including PSURs and DSURs
โข Quality Management Systems for Biotech: Implementing and maintaining quality management systems in compliance with ISO and other relevant standards
โข Marketing and Advertising Compliance: Regulatory requirements for biotech marketing and advertising, including labeling, off-label promotion, and social media regulations
โข Biotech Supply Chain Management: Managing biotech supply chains in compliance with GDP and other relevant regulations
โข Biotech Data Privacy and Security: Protecting biotech data in compliance with GDPR, HIPAA, and other relevant regulations
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