Overview

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 /PBRERs) for medicinal products in the context of current legal framework at the European and Global level.

Course participants will learn all they need to know about the requirements set out in the ICH E2C(R2) (plus Q&A Annex) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) - Module VII, as well as global acceptability and local variability in the requirements.

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

Practical exercises involving key aspects of safety medical writing, based on real-life examples, will be included.

Participant Testimonials

Participating in this training course was a short but noteworthy adventure. I learned a lot of new things and understand that there is more to learn. I liked the group assignments, where we could brainstorm with the other participants. Knowing that you are not alone in this ocean of knowledge was relieving. – Mariela Mazneva – Pharmacovigilance Expert, Ecopharm EOOD, Bulgaria

Featured topics

- Introduction to the PSUR/PBRER, general principles and structure
- Planning process and interdepartmental responsibilities
- Writing of PSUR/PBRER: Introductory sections, Presentation of findings, Data evaluation, Benefit-Risk analysis, Critical parts
- Practical exercises on: PSUR writing, PSUR planning process, Medical writing

Who should attend?

This course is intended for 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 clinical medical writing experience who wish to extend their professional skills in aggregate reports.

Learning objectives

- Explain the ICH E2C (R2) guideline, including the associated Q&A
- Evaluate the EU GVP Module VII standards and templates
- Discuss strategies to overcome the most frequent challenges in managing a team of authors and data considerations in a PSUR
- Recognize important legal and regulatory context of PBRER, including local regulatory intelligence tips
- List key principles of safety medical writing

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