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."
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