Startdate:
6 May 2010 - 7 May 2010 Purpose:
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. Content:The European System for Medicinal Products
General Background to EU and Institutions
Parliament, Council, Commission and Enterprises DG, Pharmaceutical Committees Single market ICH cooperation Ph.EUR Role and structure of work The European Medicines Network, CMD, Head of Agencies Interactions with EMEA Sources of Information
EMEA
Role and structure Management Board, CHMP, COMP, EU experts, rapporteurs Working parties (guidelines etc.) Interactions with EMEA EEA EU Pharmaceutical Legislation and Law Frame
Approval and Distribution of Medicinal Products in the EU
Referrals Pediatrics Orphan Drug Legislation Clinical Trials Data Protection Liability Labelling Pharmacovigilance Advanced Therapies
Future Pharmaceutical Legislation
Burkhard Sträter
Burkhard Sträter, Lawyer, Anwaltskanzlei Sträter, Germany Zaide FriasEMA, UK Dorthe PoulsenChief legal adviser, Licensing Division, Danish Medicines Agency, Denmark
Doris Stenver
Chief Medical Doctor, Danish Medicines Agency, Denmark
Dr. Birka Lehmann
Director and Professor, Head of Licencing Division 3, BfArM, Germany
Tina Engraff
Legal Adviser, Danish Medicines Agency, Denmark
Jakob Lundsteen
Legal Adviser, Danish Medicines Agency, Denmark Target:
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, EMEA, the collaboration between the different institutions) Prerequisites: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. Literature: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. |
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Price:DKK 10,750.00 (approx. EUR 1,445.00) + VAT 25%, included: course fee, meals during the days, coursematerial, networking dinner Exam fee DKK 1,500 (approx. EUR 202) Cancellations must be in writing and must be sent to Medicademy. Cancellations later than two weeks prior to the course, a cancellation fee of 50% of the course fee is charged. Cancellations one day before or on the day of the course, a cancellation fee of 100% of the course fee is charged. A booked seat can be transferred to another qualified participant free of charge. In the event of circumstances beyond our control, Medicademy reserves the right to change the programme, lecturers, dates or venue, if necessary. If Medicademy cancels a course, the course fee will be fully reimbursed. Registration deadline:
29 April 2010 Exam:Date of examination: June 10, 2010 You 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. Remember to register for the exam separately! |
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Register:
DKK 10,750.00
VAT, 25% DKK 2,687.50
Incl. VAT DKK 13,437.50
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