Medical Writing of Periodic Safety Update Reports (PSUR/PBRER) Virtual Live Training Course, 4-6 May 2021
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Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)
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 Live Virtual 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.
Credit
Elective:2.0
Description
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 Live Virtual 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 will you learn
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 will you 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