Overview

This course is part of the Benefit-Risk and Medical Writing week offering

Participants will be provided with preparatory material to facilitate their learning process at the group exercises onsite.
Participants are required to bring their laptops with them for this course.

Quality of PSURs and PBRERs became a major compliance issue globally, as the complexity of the documents increased hand in hand with unprecedented level of regulatory scrutiny and attention.

This practical training course will help industry professionals to keep up with the new demands. It introduces essential aspects of medical writing of aggregate safety reports (PSURs and PBRERs) in the context of 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) (plus Q&A) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) - Module VII, as well as global acceptability and local variability in the requirements.

Course will demonstrate best practices in source data collection, about the essential role of quality checks (QC) during the whole process of report preparation, and about critical aspects of medical writing, including data editing and presentation.

A practical exercise involving key aspects of the medical writing process, based on real-life examples, will be included.

What participants from the previous course say:

"Very informative course about the rules and regulations of ICH and GVP for writing PBRERs. Both Jan and Zuzana were very approachable and had a vast knowledge in the area. I had very limited knowledge of signal detection as I am new to this area, so perhaps a little bit more interaction with faculty would have been better for this practical assessment but, overall I learnt more about this area and all that was covered in course was extremely helpful and will definitely help me in my job."

What you will learn

PSUR: regulations, format and content of the document
PBRER: regulations, format and content of the document
Practical aspects of planning and medical writing related to aggregate reports

Who should attend?

This course is intended for the professionals working within the pharmaceutical industry in pharmacovigilance, drug safety, regulatory, and medical writing positions. Professionals most likely to benefit from this training are newcomers to the medical writing and/or pharmacovigilance positions or writers/specialists with intermediate level of experience who wish to extend their professional skills in aggregate reports.

Learning objectives

At the conclusion of this course, participants will be able to:

Understand interpretation and application of the ICH E2C (R2) guideline, associated Q&A, and EU GVP Module VII standards and templates
Learn how to overcome the most frequent challenges in getting the correct and complete source information performing effective quality checks, editing, table and graphical presentation, methodologies, and publication tips
Understand important legal and regulatory context of PBRER, including local regulatory intelligence tips

Participants will complete two knowledge checks. The first will take part before the practical exercise from medical writing, focused on drafting the key parts of PSUR in groups based on real-life examples. The second one will be completed after the course end in an online platform, consisting of a standard multiple choice knowledge test.

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

Focus
Flexibility
Convenience
Cost Effectiveness

For more information please contact EMEA@DIAglobal.org

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Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)