69.00€
During this course you will learn the role and responsibilities of Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Medicinal Products for Human Use (CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh). You will study their impact on the pharmacovigilance activities performed by marketing authorization holders.
The course is divided in to 5 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.
You will learn the role and responsibilities of the Pharmacovigilance Risk Assessment Committee and its role in assessing the aspects of risk management of human medicinal products. You will learn the role and responsibilities of the Committee for Medicinal Products for Human Use which plays a vital role in the authorisation of medicines in the EU. Last but not least you will learn about the Coordination Group for Mutual Recognition and Decentralised Procedures which was establishes for examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States. Moreover you will study the division of responsibilities between CHMP, PRAC and CMDh concerning pharmacovigilance decisions making process. Finally you will also learn how safety decisions are implemented at European level.
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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