Global Certificate in PharmaTech IP: Regulatory Landscape
-- ViewingNowThe Global Certificate in PharmaTech IP: Regulatory Landscape is a comprehensive course designed to provide learners with an in-depth understanding of the regulatory landscape in the pharmaceutical industry. This course is essential for professionals seeking to advance their careers in regulatory affairs, pharmaceutical sciences, and related fields.
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⢠Global Pharmaceutical Regulations: Overview of international regulations and guidelines governing pharmaceutical industry, including ICH, WHO, FDA, EMA, and others.
⢠Regulatory Affairs: Understanding the role and responsibilities of regulatory affairs professionals in ensuring compliance with regulations and guidelines.
⢠Pharmaceutical Quality Systems: Overview of quality systems such as GMP, GLP, and GCP and their impact on pharmaceutical R&D and manufacturing.
⢠Clinical Trials Regulations: Regulations and guidelines governing the conduct of clinical trials, including ICH GCP and FDA regulations.
⢠Pharmacovigilance: Overview of pharmacovigilance and its role in ensuring patient safety, including regulations and guidelines governing pharmacovigilance activities.
⢠Regulatory Submissions: Processes and requirements for preparing and submitting regulatory applications, including eCTD and other electronic submission formats.
⢠Regulatory Inspections and Audits: Understanding the inspection and audit process, including preparation, execution, and follow-up.
⢠Regulatory Intelligence: Overview of regulatory intelligence and its role in staying up-to-date with regulatory changes and emerging trends.
⢠Regulatory Strategy: Development of regulatory strategies to support product development, approval, and lifecycle management.
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