Medicademy Pharmacovigilance consists of seven modules and is a flexible part-time postgraduate education in pharmacovigilance with special emphasis on understanding pharmacovigilance issues based on a practical industry approach. more »

A team of experienced Regulatory Affairs Professionals has designed the diploma course and The Danish Medicines Agency and the Danish University of Pharmaceutical Sciences are both actively involved in the continuous development of the education.

There are 3 ways you can benefit from the 12 Medicademy modules: 1) MPRA - Master in Pharmaceutical Regulatory Affairs, 2) Diploma in Pharmaceutical Regulatory Affairs and 3) Individual modules.more »

MEDICADEMY REGULATORY AFFAIRS MODULE 2, EU APPLICATIONS FOR MARKETING AUTHORISATIONS, PAEDIATRIC INVESTIGATION PLANS, CLINICAL TRIALS AND ORPHAN DRUG DESIGNATION, SEPTEMBER 2 - 4, 2009 still has seats available!
DEADLINE FOR APPLICATION: AUGUST 2, 2009. In 2008 Module 2 was fully booked months in advance - REGISTER NOW to be sure to get a seat! Whereas Module 1, The Pharmaceutical Law Frames in the EU, provides knowledge of the pharmaceutical legislation in EU, Module 2 – ” EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation” focuses on the implementation of this legislation, e.g. on the procedural and operational aspects when applying for marketing authorisations, clinical trials and orphan drug designation in EU. In addition you will learn how to comply with the EU requirements for paediatric investigation plans, risk management plans as well as how to obtain scientific advice from EU. During the 3 days the participants will interact with the expert lecturers and will work with case stories in smaller group sessions to illustrate the necessary considerations for the different types of applications. The module will give you a solid basis for evaluating the opportunities and consequences related to different types of products and submissions and subsequently to plan and operate within the frame work of the various application procedures. Module 2 will also be an essential basis for the modules concentrating in more details on the Quality, Safety and Efficacy aspects or on strategic considerations as well as the modules covering the requirements in other parts of the world. more »