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Medicademy Pharmacovigilance Module 1. Principles of Pharmacovigilance
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Registration deadline:
19 February 2013 Exam:Please remember that you can take the exam in your own country. Further information on the exam will follow. Please note: The course design of Medicademy Pharmacovigilance is highly flexible, and each module is a complete module, which can either be taken as an individual module or as one module in a series of modules - and i any arbitrary order. |
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Register:
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Startdate:
19 March 2013 - 21 March 2013 Purpose:
AIM: BY THE END OF THIS MODULE, THE STUDENT SHOULD BE ABLE TO:
Understand the basic principles of pharmacovigilance, including the factors of ADRs, pharmacovigilance legislation and regulations, the methods used to
collect and evaluate adverse drug reactions, preferred communication channels when communi¬cating
with authorities, and the ethical considerations and implications of pharmacovigilance.
Analyze and evaluate methods and data in drug safety reporting, and to analyse and evaluate regulations and guidelines in pharmacovigilance.
Use best practices in pharmacovigilance working processes, prepare safety assessments and reports, design appropriate pharmacovigilance working methods, and operate in a highly
dynamic and constantly changing environment. Content:
CONTENTS
- History of Pharmacovigilance - Risk in Pharmaceutical Products - Safety Data - Legislation - Clinical Trials - Authorities and Clinical Trials - Pharmacovigilance Legislation - Requirements for - Periodic Safety Update Reports (PSUR) - Post-Authorisation Safety Studies (PASS) - Risk Management Plans (RMP) - Pharmacovigilance Evaluation and - Safety-Related Actions - Specific Safety Issues - Authorities and Post-Marketing Safety Evaluation - Trends, Challenges and Opportunities - Communication COURSE LEADERSBina Kramhøft Schack, Gambro, Denmark Doris Stenver, Danish Medicines Agency, Denmark
LECTURERS
The Medicademy Pharmacovigilance Faculty employs lecturers from all over Europe, including the Pharma¬- ceutical Industry, the EMA, National Authorities, Universities and Organisations. All lecturers work within their teaching area and are experts within their field. Prerequisites:ENTRY REQUIREMENTS
In order to maintain a professional level in the programme, applicants are required to have, as a minimum, a relevant Bachelor Degree and 2 years of experience within pharmacovigilance from the pharmaceutical/biotech industry or regulatory authorities, or similar qualifications. Applicants, who do not meet the entry requirements, will be considered on a case-by-case basis. Lack of formal qualifications need not be a barrier to study, and exemptions may be granted case by case. For each module, Medicademy will accept for up to 20 % of the seats to be occupied by applicants with limited experience within the pharmacovigilance area, as long as they are able to benefit from and actively participate in the module activities. Approximately 25 applicants will be admitted to each module. Please note that applications will be considered in order of receipt. |
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Plads til diskussion – rigtig godt
Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer
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Minna K. Jørgensen
Minna Kjær Jørgensen is Program Director, Medicademy Pharmacovigilance and also responsible for Introduction to Safety & Pharmacovigilance and Medical Advertising Standards.
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Lif Education, Diploma in Basic Pharmaceutical Medicine, Clinical Research, Drug Development, Medicademy Pharmacovigilance, Medicademy Regulatory Affairs, RA, PV, Pharmacovigilance, Regulatory Affairs
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