69.00€
The course covers information on additional risk minimization (aRMM) as an integral part of the Risk Management Plan. Thanks to this course, you will learn about Management of the process of planning, preparation, writing, review, quality control, distribution and evaluation of the effectiveness of the aRMM. I will draw attention to important issues such as roles and responsibilities of the different stakeholders involved in the implementation of the aRMM. You will become acquainted with adjustment of risk minimisation activities proportionate to the impact on patient safety of the identified risks and managing the process of developing the first aRMM. You will discover management of the process for updating the ARMM. What’ s more, you will get to know about process of evaluating the effectiveness of the activities carried out in the form of the aRMM and examples of process and outcome indicators.
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.
I am Karolina Wawrzyniak and I am Senior Pharmacovigilance Specialist 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 collage I participated in many courses in the field of Pharmacovigilance, Regulatory Affairs and Clinical Trials:
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