Practical course on Pharmacovigilance Aggregate reports

🚑 Master the Art of Pharmacovigilance with Our Expert-Led Course on Aggregate Reports 📚

Course Title: Practical course on Pharmacovigilance: Aggregate reports, DSUR, PBRER, PADER, RMP, Good Pharmacovigilance Practices

Introduction to Aggregate Reporting Aggregate reporting is a critical aspect of ensuring the safety of medicinal products. It involves the preparation and submission of safety reports to regulatory agencies around the world. This essential function is integral to the safety monitoring process for pharmaceutical products.

The Essence of Aggregate Safety Reports

• Development Safety Update Reports (DSUR): These are specific aggregate safety reports required for molecules in development. They provide updates on safety information collected from clinical trials and post-marketing experience.
• Periodic Adverse Drug Experience Reports (PADERs) & Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PBRERs): Once a product has marketing authorization, PADERs and PBRERs are submitted to regulatory bodies to provide updates on safety and benefit-risk profiles.
• Regular updating of product labels: Based on the analysis of worldwide safety reports, product labels are updated to ensure that patients and healthcare providers have the most up-to-date information on safe usage.

Understanding Aggregate Reporting Requirements Quality in aggregate reporting has become a major compliance issue due to its complexity and the regulatory scrutiny it faces globally. This practical training course is designed to assist industry professionals in mastering the regulatory requirements related to pharmacovigilance medical safety writing as per the current framework.

Learning Objectives:

• Understanding ICH E2C and E2F, GVP Module VII, and global acceptability.
• Source data collection & Report Preparation: Learn how to collect source data effectively and prepare high-quality aggregate reports.
• Medical Writing Skills: Enhance your ability to write clear, concise, and compliant aggregate reports, including line listings and summary tabulations.
• In-depth Knowledge of Templates: Gain expertise in using DSUR, PBRER, RMP, and PADER templates correctly and effectively.

Who Should Attend? This course is tailored for professionals working within the pharmaceutical industry in roles related to pharmacovigilance, drug safety, regulatory affairs, and medical writing. It is particularly beneficial for:

• Newcomers to medical writing and/or Pharmacovigilance positions
• Writers or specialists with intermediate experience seeking to enhance their skills in aggregate reports

Key Topics:

• DSUR: Regulations, format, and content of the document
• PBRER: Regulations, format, and content of the document
• Aggregate Reporting Practicalities: Planning and medical writing aspects
• RMP: Regulations, format, and content of the document
• PADER: Regulations, format, and content of the document

Career Opportunities in Pharmacovigilance:

• Fresher Roles: As a drug safety associate or physician if you are a life science graduate or HCP.
• Intermediate Level: Part of signal management or aggregate writing/PV medical safety writing teams after 3 years of experience.
• Management Roles: Management positions in pharmacovigilance with certification and over 5 years of experience.
• Additional Roles: Quality Assurance, quality control, database administration, etc., based on interest and experience.

Join Our Comprehensive Course Today! Embark on a journey to become an expert in pharmacovigilance and aggregate reporting. Enhance your career prospects with our detailed course designed by industry specialist Srikanth Gorantla. Secure your place now and take the first step towards mastering the art of safety in the pharmaceutical industry! 🚀✨

Enroll Now to access cutting-edge knowledge, practical insights, and career advancement opportunities in the field of Pharmacovigilance!