69.00€
Would you like to know what is and what are the objectives of Risk Management Plan? If so, please join this course. The objective of this course is to perform introduction training to Risk Management Plan by getting the objectives and the key concepts of the GVP Module V.
The aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. To this end, the RMP contains:
As knowledge regarding a medicinal product’s safety profile increases over time, so will the risk management plan change.
Would you like to know more? Join the course!
After course completion, student:
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.
Medical Projects Manager – skilled in leading, motivating, and coordinating teams and projects. Pharmacist. Mother of a 7-year-old girl.
With over 10 years of experience in the pharmacovigilance sector and expertise in medical information. More than three years of experience as a backup EU QPPV at Poland’s largest pharmaceutical company, Zakłady Farmaceutyczne “POLPHARMA” S.A. Contributed to the development and maintenance of a new set of SOPs and PSMF.
Pioneered a new model of pharmacovigilance activities, overseeing the procurement of pharmacovigilance services. Led the project to establish a new global pharmacovigilance structure for the Polpharma Group.
Nearly four years of experience in people management as the coordinator of periodic reporting and risk minimization teams. Managed 4-5 direct reports.
Responsibilities included:
Skills:
After-hours interests:
Don’t miss out on this opportunity to revolutionize your employee development process with AIDIFY’s freemium license. Fill out our form to get started today!
Reviews
There are no reviews yet.