What you'll 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
Requirements
Any lifescience graduates including Pharmacy, biotechnology, MSc, BSc, BDS
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.
Overview
Section 1: Overview of Pharmacovigilance
Lecture 1 Why Students should do Pharmacovigilance course
Lecture 2 Importance of Pharmacovigilance
Lecture 3 Scope of Pharmacovigilance
Lecture 4 Job Opportunities
Lecture 5 Which companies hire pharmacovigilance professionals
Lecture 6 Future Scope of Pharmacovigilance
Section 2: Introduction
Lecture 7 Introduction to Pharmacovigilance
Lecture 8 History Of Pharmacovigilance
Lecture 9 The Thalidomide story
Lecture 10 Role Of Pharmacovigilance in ensuring the safety of medicines
Section 3: Regulatory Requirements
Lecture 11 Mechanism of Action Of Medications
Lecture 12 Terminologies used in Pharmacovigilanace
Lecture 13 The Process of Reporting & Evaluating ADR
Lecture 14 Regulatory Requirements Related to Pharmacovigilance
Section 4: Assesment of Risk benefit & risk management plan based on PV
Lecture 15 Risk benefit & Risk management based on Pharmacovigilance data
Lecture 16 The use of Pharmacovigilance Tools & Techniques
Section 5: Ethical Considerations & methodologies in Pharmacovigilance
Lecture 17 Ethical Considerations related to Pharmacovigilance
Lecture 18 Methodologies Used in Pharmacovigilance
Lecture 19 Seriousness expectedness & casualty assesment
Lecture 20 Aggregate safety Reports
Section 6: Pharmaceutical Regulations & Signal Detection
Lecture 21 Pharmaceutical Regulations in Various countries
Lecture 22 Signal Detection & Data Mining
Section 7: Pharmacovigilance Databes, Softwares used
Lecture 23 Pharmacovigilance Databases
Lecture 24 Softwares used in Pharmacovigilance
Section 8: Process of Repoting Adverse Drug Reaction
Lecture 25 Process of Reporting an ADR
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.


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