69.00€
Informed consent is one of the most crucial processes in the clinical trials. Well performed informed consent process ensures that the subject’s rights and well-being is protected. Following unethical experiments performed in the past which are now black cards of the clinical trials history, several guidelines were developed f.e. Declaration of Helsinki which strongly underline that subject can be enrolled into the study only after the informed consent is given. This is also reflected in the ICH GCP and local regulations. This course provides general overview on informed consent process and form and explains what the difference between those 2 terms is. Course covers also requirements towards the Inform Consent Form (ICF), documentation of the consent process, parties involved in this process and regulations and guidelines. During the course, participant will be provided with real examples of informed consent forms to better understand how to work with this document and how to verify the consent process. Course is followed by bank of questions and case study exercise so the participant can verify the knowledge.
Excellent communicator with can-do attitude and strong desire to learn. Project Manager with line management responsibilities focused on quality. Currently fulfilling the role of an Oversight Portfolio Manager working on a governance level, responsible for several studies of one client and oversight and support a group of CTMs allocated for those projects. Client oriented and dedicated team player. Long-term goal is to have an independent and responsible position as a global project director. Experience in pharmaceutical marketing, medical affairs and clinical trials gained in pharma companies and CROs.Founder and member of Polish Pharmaceutical Students’ Association. Member and head of the training group at Polish Association for Good Clinical Practice (GCPpl). Pharmacist with strong interest in clinical pharmacy. Academic teacher delivering lectures related with clinical trials.
Certificates: Soft Skills Trainer Certificate, Prince2 Foundation Training Certificate, Barnett GCP Certificate. Laureate and winner of a 3rd place of the national competition “Leaders of Clinical Trials (2021)” in the category Project Manager. Scholar of Leslaw A. Paga Foundation in the program “Healthcare Leaders”.
Privately foodie and enthusiast of cooking, travelling and fantasy books.
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