Global Certificate in Pharma Regulatory Affairs & Forecast
-- ViewingNowThe Global Certificate in Pharma Regulatory Affairs & Forecast is a comprehensive course designed to equip learners with critical skills in pharmaceutical regulatory affairs and market forecasting. This course is essential for professionals seeking to advance their careers in the pharmaceutical industry, where regulatory compliance and market understanding are vital.
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โข Introduction to Pharma Regulatory Affairs: Understanding the regulatory landscape, stakeholders, and key concepts.
โข Regulatory Pathways: Overview of drug development pathways, including generic, biosimilar, and innovative drug approvals.
โข Regulatory Strategy: Developing a regulatory strategy for drug development, including timelines, milestones, and risk management.
โข Regulatory Affairs in Clinical Trials: Overview of regulatory requirements for clinical trials, including protocol approvals, informed consent, and safety reporting.
โข Labeling and Packaging: Understanding the regulatory requirements for drug labeling and packaging, including content, format, and language.
โข Pharmacovigilance and Adverse Event Reporting: Overview of pharmacovigilance and adverse event reporting requirements, including safety monitoring and risk management.
โข Quality Assurance and Control: Understanding the regulatory requirements for quality assurance and control, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
โข Regulatory Submissions: Overview of regulatory submissions, including content, format, and timelines.
โข Regulatory Inspections and Audits: Understanding the regulatory inspection and audit process, including preparation, execution, and follow-up.
โข Pharma Forecasting: Overview of pharmaceutical forecasting, including market analysis, sales projections, and scenario planning.
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