17 September 2013 - 18 September 2013
Lersø Parkallé 101
2100 København Ø
UNDERSTAND the relations between pharmacovigilance and the processes of application and registration, focusing on areas and phases in drug development processes in which the clinical development, registration, and pharmacovigilance units co-operate closely; overview of the pharmacovigilance staff and their roles in the pre-application phase.
ANALYSE the different pre-application tasks for the pharmacovigilance staff in relation to: preparation of clinical study protocols, conduct of clinical studies, preparation of annual safety reports (SUSARs), preparation of integrated clinical study reports, preparation of scientific advice in relation to the preparation of clinical trial applications (e.g. endpoints, statistical power, safety parameters, etc.)
USE the obtained knowledge to achieve a higher quality of input from the pharmacovigilance staff and to smoothen cooperation between the clinical development, registration and pharmacovigilance units.
- Global Development Plan
- Pharmacovigilance System Master Files
- Handling of Safety Data during a Clinical Trial
- Clinical Study Report with Specific Focus on the Safety Sections
- Clinical Summary and Overview and Summary of Product Characteristics
- Applications for New Medicinal Products
- Paediatrics - Authority Perspective
- The Centralised Procedure and Safety Related Referrals - EMA Perspective
- Mutual Recognition Procedure and Decentralised Procedure
- Safety Variations & ApplicationsCourse leaders:
Doris Stenver, Danish Health and Medicines Authority, Denmark
Ea Dige, ALK Abelló, DenmarkLecturers:
The Medicademy pharmagovigilance 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.
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.