69.00€
During this course you will learn about the periodic safety update reports single assessment procedure and informal Work-Sharing procedure for follow-up for PSUSA for nationally authorised products.
The course is divided in to 9 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.
Participating in this course you will learn the objectives of the periodic safety update reports and you will find the information for which medicinal products they must be prepared. You will be shown the way of submission of periodic safety update reports to the PSUR repository of the European Medicinal Agency. You will learn about the periodic safety update reports single assessment procedure. You will study what is the table of lists of nationally authorized medicines involved in PSUR single assessments and regulatory outcomes for and how to use it in practice. Additionally you will learn where to find the PSUSA outcome to implement it to your medicinal product documentation.
In the second part of the course you will learn what were the rationale for developing Informal Work-Sharing procedure for follow-up for PSUSA for nationally authorised products (PSUFU). You will study the prerequisites for successful PSUFU procedure. Furthermore you will learn detailed outlines of the PSUFU procedure. Finally at the end you will learn what are the benefits of the PSUFU procedure.
Hello, my name is Andrzej Czesławski. I am a graduate of the Faculty of Pharmacy at the Medical University of Warsaw. Since 2005 I work for the polish health authority – the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. I have more ten years’ experience in regulatory affairs especially in European procedures. From 2005 to 2015, I worked in the area related with coordination of the process of granting marketing authorization of the medicinal product in the Mutual Recognition and Decentralised Procedures starting as a junior specialist and finishing as a head of the unit and deputy director of the department. At the end of 2015 I decided to change something in my professional life and joined pharmacovigilance teem to look for some more challenges as a head of the department. Additionally I am an European expert of the European Medicinal Agency. Lastly what I am mostly proud of is that I am a member of the CMDh – the Co-ordination Group for Mutual recognition and decentralise procedure. In 2011 I was officially nominated as an alternate member and since July 2020 I am a member of the CMDh. Being a part of the CMDh allows me to use my experience in the field of regulatory affairs and pharmacovigilance.
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