Startdate:
13 November 2012 - 15 November 2012 Location:
Medicademy
Lersø Parkallé 101
2100 København Ø
Purpose:
AIM: BY THE END OF THIS MODULE, THE STUDENT SHOULD BE ABLE TO:
Understand the constituents of post-marketing surveillance, including the definition and scope of post-marketing surveillance, risk management plans, post-authorisation safety studies, types of studies, post-marketing spontaneous reporting, signal detection, tools for signal detection, interpretation of findings, actions following a confirmed signal, SPC updates, crisis management, execution of recalls, and product life cycle management.
Analyse and post-authorise safety studies, and interpret signals and findings, etc.
Use and prepare risk management plans, update SPCs, execute recalls, and manage a product life
cycle in a highly dynamic and constantly changing environment. Content:CONTENTS
- Overview of Post-Marketing Surveillance - Risk Management Plans - PASS - Post-Marketing Spontaneous Reporting - Signal Detection - Databases for Spontaneous Reporting - Tools for Signal Detection - Current Practice of Agencies in Signal Detection - Interpretation of Findings and Documentation Hereof - Actions Following a Confirmed Signal - SPC Update and Harmonisation - Reporting of Signals - Crisis Management/Product Recall - Counterfeit - Product Life Cycle Management COURSE LEADERSDoris Stenver, Danish Medicines Agency, Denmark Ea Dige, ALK Abelló A/S, Denmark LECTURERS
The Medicademy Pharmacivigilance 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. |