Entry Level Pharmacovigilance Course
Introduction to Pharmacovigilance Global Regulatory Requirements for Pharmacovigilance, Drug Safety
Description
This entry-level pharmacovigilance course provides an introduction to the principles and concepts of pharmacovigilance, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
The course covers global regulatory requirements for pharmacovigilance, including reporting timelines, submission requirements, and reporting channels. It also explores different types of pharmacovigilance data sources, such as spontaneous reports, clinical trials, and observational studies, and how to manage this data effectively using common pharmacovigilance tools and databases.
Students will learn about the roles and responsibilities of different stakeholders in pharmacovigilance, including regulatory agencies, pharmaceutical companies, healthcare professionals, and patients. They will also explore risk management in pharmacovigilance, including signal detection, risk assessment, and risk minimization strategies.
Throughout the course, students will become familiar with pharmacovigilance terminology, abbreviations, and acronyms, and will also discuss ethical considerations and challenges associated with pharmacovigilance, such as confidentiality, informed consent, and data privacy.
Finally, the course will emphasize the importance of communication and teamwork in pharmacovigilance, and provide opportunities for students to develop these skills through group activities and case studies. Upon completion, students should be able to understand the fundamental concepts and practices of pharmacovigilance and contribute to ensuring patient safety.
What You Will Learn!
- Explain the basic principles and concepts of pharmacovigilance, including the importance of adverse drug reaction (ADR) reporting and how to identify and assess
- Comply with global regulatory requirements for pharmacovigilance, including reporting timelines, submission requirements, and reporting channels
- Use common pharmacovigilance tools and databases, such as VigiBase and EudraVigilance, for data collection, entry, analysis, and reporting.
- Manage pharmacovigilance data effectively, including data collection, entry, analysis, and reporting.
- Identify and manage risks associated with the use of medicinal products, including signal detection, risk assessment, and risk minimization strategies.
- Identify ethical considerations and challenges associated with pharmacovigilance, including confidentiality, informed consent, and data privacy
- Communicate pharmacovigilance information effectively to different stakeholders, and collaborate with colleagues in pharmacovigilance and other related fields t
Who Should Attend!
- Recent graduates or individuals with a background in pharmacy, medicine, nursing, biology, or a related discipline who are interested in pharmacovigilance. Professionals working in the pharmaceutical industry who want to expand their knowledge of pharmacovigilance. Healthcare professionals, such as physicians and nurses, who are involved in prescribing or administering medicinal products.