Essentials of Pharmacovigilance: Ensuring Medicine Safety Worldwide, Patient Protection and Regulatory Success.
Sub Category
- Science
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Objectives
- Understand the core concepts, scope, and importance of drug safety and pharmacovigilance in healthcare.
- Define and apply key pharmacovigilance terminology and principles used in the pharmaceutical industry.
- Explain the historical evolution of drug safety and how past events shaped current global practices.
- Recognize the roles and responsibilities of major regulatory authorities such as the FDA, EMA, and WHO.
- Interpret international guidelines including ICH, CIOMS, and other regulatory frameworks governing drug safety.
- Identify, classify, and analyze different types of Adverse Drug Reactions (ADRs).
- Apply methods for detecting, reporting, and monitoring ADRs through pharmacovigilance systems.
- Differentiate between passive and active surveillance techniques and their real-world applications.
- Evaluate the role of Data Safety Monitoring Boards (DSMBs) in ensuring participant safety.
- Address special safety considerations for pediatric, geriatric, pregnant, and lactating populations.
- Explore emerging trends such as artificial intelligence, big data analytics, and patient-centered approaches in drug safety.
- Analyze global challenges and future opportunities in the evolving field of pharmacovigilance.
Pre Requisites
- A willingness to learn about drug development, safety monitoring, and global health regulations.
FAQ
- Q. How long do I have access to the course materials?
- A. You can view and review the lecture materials indefinitely, like an on-demand channel.
- Q. Can I take my courses with me wherever I go?
- A. Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don't have an internet connection, some instructors also let their students download course lectures. That's up to the instructor though, so make sure you get on their good side!
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