Medicademy Module R1: The Pharmaceutical Law Frames in the EU
2 May 2012
Date of examination: June 11, 2012You can take the exam in your own country!
Medicademy arrange examinations at Embassies, Universities etc. all over the world.
Information about examination form etc. will follow.
Registration is closed
9 May 2012 - 11 May 2012
The purpose of Module 1 is to give the participants an understanding of the background of the EU legal system and the collaboration with other institutions.
By the end of this module, the student should be able to:
the principles of the EU legislative framework underpinning each step of the drug development process (pre-approval, approval and post-approval phase), and the roles and responsibilities of the key players in the EU regulatory process
how the legislation helps establish an on-going benefit-risk evaluation throughout the life cycle of a medicinal product
• Analyse and critically appraise
a medicinal product in the context of the EU legislative framework
good regulatory practices as a means of improving the regulatory environment
Content:The European System for Medicinal Products
General Background to EU and Institutions
Parliament, Council, Commission and Enterprises DG, Pharmaceutical Committees
Role and structure of work
The European Medicines Network, CMD, Head of Agencies
Interactions with EMA
Sources of Information
Role, activities and structure
Management Board, CHMP, COMP, EU experts, rapporteurs
Working parties (guidelines etc.)
Databases used for approval and surveillance
Transparency and disclosure of information
EU Pharmaceutical Legislation and Law Frame
Approval and Distribution of Medicinal Products in the EU
Marketing Authorisation System for Medicinal Products in the EU
Approval and Data Protection
Orphan Drug Legislation
Liability and Labelling
Future Pharmaceutical Legislation
Divisional Director Regulatory Affairs, H. Lundbeck A/S, DenmarkJakob Lundsteen,
Legal Advisor, Danish Medicines Agency, DenmarkLecturers:
Burkhard Sträter, Lawyer, Anwaltskanzlei Sträter, GermanyDr. Valentina Stamouli
Scientific Administrator, Regulatory Affairs, EMA, UK
Chief Medical Doctor, Danish Medicines Agency, Denmark
Deputy Head, AGES PharmMed, Austria
Dr. Birka Lehmann
Director and Professor, Head of Licensing Division 3, BfArM, Germany
To provide the participants an understanding of the pharmaceutical law frames and how this legislation is developed in the EU (regulations, directives, notes for guidance, the EU Commission, EMA, the collaboration between the different institutions)
In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt.
Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis.
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.
The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus.
The participants are expected to study and be familiar with the mandatory references in advance of the module.
Accomodation - Not included in the course fee:
Hotel Twentyseven is located in the heart of Copenhagen, close to the Town Hall Square, the Tivoli Gardens, and Copenhagen Central Station, and airport trains, S-trains, regional trains, and busses leave from the station regularly. Hotel Twentyseven has a special atmosphere based on unique experiences, living design, seductive comfort, hospitality, and an uncomplicated life. All the 200 rooms in the hotel have been designed in the well-known Scandinavian design tradition by leading Danish designers & architects. www.hotel27.dk
Fixed prices – breakfast included: Small single room - DKK 930 (approx. EUR 125), Double room for 1 person – DKK 1,080 (approx. EUR 145)
Shuttle Bus - Included in the Course Fee!
Medicademy arrange transportation by bus every day from Hotel Twentyseven in the morning to Medicademy and back again in the evening from Medicademy to Hotel Twentyseven – included in the course fee!Networking Dinner - Included in the Course Fee!
The networking dinner takes place at Hotel Twentyseven on the first night of the module - May 9, 2012!
Plads til diskussion – rigtig godt
Ann-Lisbeth Aarup Nielsen - ALK-Albelló - Regulatory Affairs Officer
Tina Jensen is Program Director, Medicademy Regulatory Affairs and responsible for Introduction to Drug Registration.
Lif Education, Diploma in Basic Pharmaceutical Medicine, Clinical Research, Drug Development, Medicademy Pharmacovigilance, Medicademy Regulatory Affairs, RA, PV, Pharmacovigilance, Regulatory Affairs