Understanding Pharmacovigilance: Ensuring Drug Safety Every Step of the Way

Pharmacovigilance stands as the cornerstone of drug safety, encompassing the detection, assessment, and prevention of adverse effects associated with pharmaceutical products. This vital science not only concerns regulatory bodies and pharmaceutical enterprises but also directly involves prescribing physicians. From the initial stages of drug research and development to the continuous surveillance of marketed drugs, ensuring drug safety is paramount.

What Sets Our Course Apart: In-Depth Training Led by Industry Professionals

Our specialized training program offers an in-depth exploration of Pharmacovigilance, combining extensive theoretical knowledge with hands-on practical training. Delivered by a team of seasoned professionals with real-time industry experience, the course is meticulously crafted to cover every aspect of Pharmacovigilance processes.

Course Highlights: A Comprehensive Journey through Pharmacovigilance Processes

• Introduction to Pharmacovigilance: Understand the foundational principles and significance of Pharmacovigilance in the pharmaceutical landscape.
• Clinical Development Process: Gain insights into the integration of drug safety measures within the clinical trials process.
• Drug Safety in Clinical Trials and Post-Marketed Drugs: Explore the nuances of ensuring drug safety both during clinical trials and after a drug reaches the market.
• Adverse Events Reporting: Delve into the various sources of adverse events reporting and understand different types of AE reporting forms.
• Expedited Reporting and Timelines: Learn about expedited reporting procedures and the crucial timelines associated with it.
• Case Assessment Practical’s: Master the art of assessing the seriousness of events, reportability of cases, and expectedness of adverse events.
• Causality Assessment and Narrative Writing: Understand how to evaluate the causality of adverse events and hone your skills in writing detailed case narratives.
• Medical Dictionary for Drug Regulatory Activities (MedDRA) and WHODD Coding: Explore the essential tools and coding systems used in Pharmacovigilance processes.
• Oracle Argus Overview: Familiarize yourself with Oracle Argus, a leading pharmacovigilance software, and its functionalities.
• Roles & Responsibilities in CROs & Sponsor in Pharmacovigilance: Gain insights into the specific roles and responsibilities within Contract Research Organizations (CROs) and pharmaceutical sponsors in the realm of Pharmacovigilance.
• Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR): Understand the preparation and submission timelines for critical safety reports.

Course Duration and Structure: A 45-Hour Intensive Learning Experience

• Duration: 45 hours (Spread Across 45 Days)
• Training Structure: Engage in a comprehensive blend of theoretical sessions, interactive workshops, and practical exercises, ensuring a holistic understanding of Pharmacovigilance principles and practices.

At the end of this course, you will emerge not just with a certificate, but with a profound understanding of Pharmacovigilance, empowering you to contribute significantly to drug safety within the pharmaceutical industry. Join us on this educational journey, led by industry experts, and take a step closer to becoming a proficient Pharmacovigilance professional.