OVERVIEW

Medical Writing of Periodic Safety Update Reports (PSUR/PBRER) Virtual Live Training Course is organized by DIA Global and will be held from May 04 - 06, 2021.

Accreditation:
• The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 9 credits.
• The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom has accredited this training course with 9 CPD credits.

Overview:
Up to date medical writing skills are key to keep up with the changing regularities in compliance reporting. In The Medical Writing of Periodic Safety Update Reports (PSUR/PBRER) Training course, you learn how to master the increasing complexity of the documents. This virtual live training will help you to gain a deeper understanding of best practices in source data collection, essential role of quality checks (QC) during the whole process of report preparation, and critical aspects of medical writing, including data editing and presentation. Gain confidence in writing aggregate safety reports (PSURs and PBRERs) in the context of the current legal framework in the EU and globally.

Course participants will learn all they need to know about the requirements set out in the ICH E2C(R2) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) – Module VII – with a global perspective and local characteristics (plus Q&A).

Hands-on Learning:
In this workshop, practical exercises will train you in the medical writing process, based on real-life cases. Our experienced instructors take you through the latest requirements of the current legal framework. Participants will complete two knowledge checks. The first will take part before the practical exercise, focused on drafting the key parts of PSUR in groups. In a second check, you will complete an online test of the learned knowledge.

Featured topics:
• Introduction to the PSUR/PBRER including legal basis
• General Principles and Structure of the PSUR/PBRER including documents and templates
• Planning Process and Interdepartmental Responsibilities
• Writing of the PSUR/PBRER Section-by-Section
? Introductory Sections
? Presentation of Findings
? Data Evaluation
? Benefit-Risk Analysis
• Quality Control and Review including examples
• Exercise in Medical Writing of Critical Parts

Learning objectives:
Learn how to:
• Draft key parts of a PSUR applying ICH E2C (R2) guideline, associated questions and answers, and EU GVP Module VII standards and templates
• Tackle challenges in getting the correct source of information for effective quality checks, editing, table and graphical presentation, methodologies, and publication tips.
• Understand the important legal and regulatory context of PBRER, including local regulatory intelligence tips.