The course covers information on Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report (PSUR/PBRER). Thanks to this course, you will learn what the purpose of this document is and how to prepare PSUR/PBRER. You will go step-by-step through the structure of the PSUR/PBRER and you will get to know what process of PSUR submission and PSUR assessment in European Union look like. Additionally, you will find out information on signal detection in the context of PSUR and you will learn how to calculate PSUR submission frequency. And finally, you will discover the tasks and responsibilities for various institutions involved in the PSUR.
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Management of Periodic Safety Update Report
Language: English 🇬🇧
License length (months): 3
Total Duration: 88 minutes
Certified by: 
69.00€
About course
THIS COURSE INCLUDES
68 minutes of Video Content
20 minutes of Course Practice Activities
Competence Test with 35 questions
Certificate after course completion
Course instructors
Karolina Smyl
Pharmacovigilance ExpertAbout
My name is Karolina Smyl and I am a Pharmacist graduated from the Warsaw Medical University in Poland, University of Alcala in Spain as well as postgraduate studies in medical business management. I have 10 years of experience working in the area of Pharmacovigilance. Currently I work as a PV Expert in Medical Department at pharmaceutical company Polpharma, which is a leader of the Polish pharmaceutical market and one of the leading drug manufacturers in the region of Central and Eastern Europe. I am also a member of Polish Society of Pharmacovigilance.
My main responsibilities include preparation of specific pharmacovigilance documents so-called aggregate reports i.e. Periodic Safety Update Reports (PSURs), Addendum to Clinical Overview (ACO), , Development Safety Update Reports (DSURs) from clinical trials, Benefit/Risk Analysis. Risk Management Plans (RMPs) and Additional risk minimization measure (aRMM) are my favorites. I am also responsible for vendors of pharmacovigilance service acquisition.
My daily activities also include updating of Extended EudraVigilance medicinal product dictionary (XEVMPD). Moreover, I supervise the processes related to Safety Data Exchange Agreements.
Since 4 years I have been a PV trainer responsible for initial and annual PV trainings for all employees of the company.
Privately, I am a mother of two wonderful children, with whom I enjoy exploring the world and spending time actively, focusing on a healthy lifestyle.
I encourage you to contact me after the course and for this purpose I leave a link to my LinkedIn.
Karolina Wawrzyniak
Country Patient Safety ManagerAbout
I am Karolina Wawrzyniak and I am a Country Patient Safety Manager at pharmaceutical company. In my daily work I deal with the broadly understood risks associated with administration of a medicinal product and benefit/risk balance. For this reason, I mostly specialize in creating Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Benefit/Risk Analysis and Safety Monitorings. I prepare reports for both the European and Eurasian countries. Furthermore, I specialize in additional risk minimization measures (aRMMs). I take part in many projects related to aRMMs - plan, implement and supervise educational materials and programs (e.g Pregnancy Prevention Programme), coordinate projects related to the switch of the drug legal status, conduct trainings related to risk minimization, cooperate with healthcare professionals, representatives of Competent Authorities, opinion leaders, medical experts and contractors. Additionally, I supervise the processes related to Safety Data Exchange Agreement (SDEA), I cooperate with lawyers and many business partners around the world. Moreover, I am also active in the field of clinical trials – I prepare Development Safety Update Reports (DSURs), supervise the list of clinical and non-clinical trials and I am responsible for collecting and verification of documentation from clinical trials.
I graduated from the Medical University in Łódź in the field of Pharmacy. After 5.5 years of study, I did a six-month internship in community pharmacy, after which I became a Master of Pharmacy. My adventure with the PV department began with an internship in a pharmaceutical company, after which I got the position of a Specialist and then was promoted to the Senior PV Specialist. But already during college I participated in many courses in the field of Pharmacovigilance, Regulatory Affairs and Clinical Trials:
- Introduction to clinical trials
- Introduction to Pharmacovigilance
- Pharmacovigilance – Professional Level of Training
- Principles of Regulatory Affairs for medicinal products, veterinary products with elements of pharmacovigilance management & Documentation for medicinal and veterinary products
- Introduction to collecting and reporting adverse events in clinical research
- Data safety and monitoring boards for clinical trials
- Pharmacovigilance Specialist at Pharmaceutical Company
By attending this course, you will learn
- Key concepts, principles, methods and tools relating to PSUR / PBRER reports
- Key regulations and guidelines for PSUR / PBRER reports (including ICH E2C guidelines)
- Characterisation of PSUR / PBRER reports. You will learn about basic abbreviations for PSUR / PBRER periodic reports
- The main concepts of benefit-risk assessment, risk-based approach
- How to review the main sources of information on adverse effects used for PSUR / PBRER reporting
- The purpose and the structure of PBRER
- How to collect important data needed to prepare PSUR
- Particular sections in PBRER template and how these sections look like
- The roles and responsibilities of different institutions involved in PSUR development
- Types of PSUR assessment procedures- differences by type of product
- Process of PSUR submission, how to assess plan operative aspects and how to manage PSUR submission frequency
- How to assess data in context of signal detection
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