69.00€
During this course you will learn about polish health authority requirements for additional risk minimization measures. You will receive a big package of practical information that will help you in future to smoothly prepare for your submission of the additional risk minimisation measures to polish health authority.
The course is divided in to 9 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.
During this course you will learn about requirements, guidelines and expectations of the Polish health authority concerning additional risk minimisation measures. Moreover you will learn how to submit additional risk minimisation measures to the Polish health authority; how the process of assessment and approval looks like and finally how to prepare a local distribution plan. You will also learn how the co-distribution process with other marketing authorisation holders should look like. You will study the expectations of the Polish health authority in the context of distribution effectiveness assessment and issues regarding archiving documentation concerning distribution process. At the end you will learn how to manage the process of preparing, maintaining, submitting and updating additional risk minimisation measures in accordance with the local requirements of the Polish health authority.
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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