Medical Writing of Periodic Safety Update Reports (PSUR/PBRER) Virtual Live Training Course
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).
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.
What participants from previous course say:
"This was an amazing session organized by DIA. Really helped a lot in better understanding of various aspects regarding PSURs. Special thanks to faculty for those extra efforts and taking special care of all the participants."
- 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
Who should attend?
This course is designed for professionals working within the pharmaceutical industry in pharmacovigilance, drug safety, regulatory, and medical writing positions.
In order to benefit from this training course and extend your professional skills in aggregate reports, you should have some experience in either medical writing or pharmacovigilance.
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.
- Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
- Mac OS X: 10.5, 10.6, 10.7
- Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4
- Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
- Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
- Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
- Linux: Mozilla 1.7, Firefox 2/3/3.5
- Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
- Mac OS X: Intel processor, At least 512 MB RAM
- Linux: At least 512 MB RAM
- 800x600 pixel resolution or greater (1024x768 pixels recommended)
To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test
Minimum System Requirement
Internet Connection Speed