Startdate:
8 October 2013 - 10 October 2013

Location:
Medicademy
Lersø Parkallé 101
2100 København Ø

Purpose:
By the end of this module, the student should be able to:

Understand the basic principles of pharmacovigilance systems, the organisation of a pharmacovigilance department and its interfaces with other departments, the standard operational procedures in a pharmacovigilance department, the use and access to databases, electronic submission of safety data, MedDRA, the QP, PSURs, legislation, pharmacovigilance agreements, compliance, and inspections and audits.

Analyse and evaluate methods and data in drug safety reporting, and analyse and evaluate regulations and guidelines in pharmacovigilance and pharmacovigilance systems

Use best practices in drug safety reporting, including relevant SOPs, submit data electronically, use pharmacovigilance agreements, prepare PSURs, use databases, prepare and follow up on audits and inspections by authorities, and operate in a highly dynamic and changing environment

Content:
- The organisation of a pharmacovigilance department
- Operative procedures
- Databases
- MedDRA
- Qualified person
- Literature surveillance
- PSURs
- Pharmacovigilance agreements
- Quality assurance and control
- Compliance
- Inspections and audits
- Mergers & acquisitions

Course leaders:
Bina Kramhøft Schack, Gambro, Denmark
Lone M. Hansen, Eli Lilly, Denmark

Lecturers:
The Medicademy pharmacovigilance faculty employs lecturers from all over Europe, including the pharmaceutical 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.