Executive Development Programme in Biotech Regulations and Compliance
-- ViewingNowThe Executive Development Programme in Biotech Regulations and Compliance is a certificate course designed to provide learners with critical insights into the regulatory frameworks governing the biotechnology industry. This program emphasizes the importance of compliance in biotech, an area of increasing significance given the rapid growth and innovation in the sector.
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⢠Introduction to Biotech Regulations: Overview of global and regional biotech regulations, including ICH, FDA, EMA, and other relevant agencies.
⢠Regulatory Affairs in Biotech: Understanding the role of regulatory affairs in biotech companies and the key responsibilities of regulatory affairs professionals.
⢠Clinical Trials Regulations: Overview of regulations governing clinical trials, including ICH GCP guidelines and FDA requirements.
⢠Quality Assurance and Control: Best practices for quality assurance and control in biotech companies, including compliance with cGMP regulations.
⢠Pharmacovigilance and Risk Management: Understanding pharmacovigilance and risk management in biotech, including adverse event reporting and signal detection.
⢠Regulatory Submissions: Best practices for preparing and submitting regulatory applications, including eCTD submissions.
⢠Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits, including responses to 483s and warning letters.
⢠Labeling and Promotional Regulations: Understanding regulations governing biotech product labeling and promotional materials, including FDA requirements.
⢠Regulatory Strategy: Developing a regulatory strategy for biotech products, including considerations for global market access and life cycle management.
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