69.00€
Would you like to know what is and what are the objectives of Company Core Safety Information (CCSI)? If so, please join this course. The objective of this course is to perform introduction training to Company Core Safety Information and Product Information Update based on updated knowledge about product safety profile.
What is CCSI? All relevant safety information contained in the company core data sheet prepared by the marketing authorisation holder and which the marketing authorisation holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification. It is the reference information by which listed and unlisted are determined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.
Would you like to know more? Join the course!
After course completion, student:
Pharmacovigilance and Regulatory Affairs Expert now mainly responsible for regulatory issues, including audit of the dossier, preparation and submission of documentation to the competent authorities. Involved in the work of the Pharmacovigilance Department including monitoring of safety information, case processing and preparation of periodic safety update reports. Biologist by training and graduate of studies in Pharmacoeconomics, HTA, Marketing and Pharmaceutical Law on Business School of Warsaw University of Technology. Lecturer has the title of Certified Regulatory Affairs Manager (CeRAM) at the Master level.
Over 15 years of experience in Pharmacovigilance and Regulatory Affairs area. Engaged in many processes of Marketing Authorisation applications, submission of postmarketing variations and renewals. Involved in preparation and verification of packaging information and verification of promotional materials. Experienced in collecting, translating and processing of Individual Case Safety Reports (ICSRs) and follow-up reports, preparation, implementation and update of Standard Operation Procedures (SOPs) concerning Pharmacovigilance.
Personally a mother of twins with good organization and management skills. Interested in Interior design, confectionery, local social and charity activities.
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:
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