Certificate in PharmaTech and Regulatory Affairs
-- ViewingNowThe Certificate in PharmaTech and Regulatory Affairs is a comprehensive course designed to meet the growing industry demand for professionals with expertise in pharmaceutical technology and regulatory affairs. This program equips learners with essential skills required to navigate the complex regulatory landscape, ensuring compliance and driving success in the pharmaceutical sector.
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โข Introduction to PharmaTech and Regulatory Affairs: Overview of the pharmaceutical technology and regulatory affairs landscape, key players, and current trends.
โข Pharmaceutical Development and Life Cycle Management: Understanding the drug development process, including preclinical and clinical trials, and how to manage a drug's life cycle from approval to market withdrawal.
โข Regulatory Compliance and Quality Assurance: Overview of regulations and guidelines, compliance requirements, and quality assurance principles in the pharmaceutical industry.
โข Pharmaceutical Regulations and Guidelines: Deep dive into the regulatory landscape, including FDA, EMA, and ICH guidelines, and their impact on pharmaceutical development and commercialization.
โข Pharmaceutical Product Registration and Approval: Process for registering and obtaining approval for pharmaceutical products in different markets, including new drug applications, abbreviated new drug applications, and generic drug applications.
โข Pharmacovigilance and Risk Management: Understanding the role of pharmacovigilance in monitoring and managing the safety of pharmaceutical products, including adverse event reporting, signal detection, and risk management planning.
โข Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs): Overview of GMPs and GLPs, including their role in ensuring the quality and safety of pharmaceutical products.
โข Regulatory Inspections and Audits: Preparation for and management of regulatory inspections and audits, including understanding the inspection process and how to respond to inspection findings.
โข Regulatory Strategy and Planning: Development of regulatory strategies and plans, including how to align regulatory plans with product development and commercialization goals.
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