69.00€
Monitoring activities must be documented as per the ICH GCP, therefore there are several documents related with the monitoring visits: confirmation and follow-up letter, site monitoring visit report, remote monitoring visit report, contact report and crucial correspondence. During the course, the participants will learn different types of monitoring documents generated before, during and after clinical phase of the study as well as understand which SOPs and study instructions are related with monitoring documents. The aim of the course is to learn how to prepare monitoring visit reports and use SVR annotations, how to prepare a contact report and a remote monitoring visit report and what are the differences. The important part of the course will be also dedicated to language and grammatical requirements, SVR workflow and a role of the report reviewer. Participant will understand what is the difference between action items and comments, as well as how to report protocol deviations. After the course, the participant will know how to create a confirmation and follow-up letter, how to use monitoring templates and what are the expectations in terms of monitoring documents filing. Understanding of types of documents related with monitoring visits followed by practical skills in terms of documents creation is a crucial aspect of clinical trial monitoring. After the course, participants can check the knowledge by taking the Q bank and practical questions.
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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