Seminar 1 "European pharmaceutical regulatory environment":
13-16 (17) September 2011

Seminar 2 "Regulatory Procedures in the EU, USA, Japan and other regions": 25-28 (29) October 2011

Seminar 3 "Registration of blood products, vaccines and ATMPs": 14-16 (17) December 2011

Seminar 4, Part I "Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier": 24-27 January 2012

Seminar 4, Part II "Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements": 6-9 (10) March 2012

Seminar 5 "Specific considerations for the development and authorisation of biopharmaceuticals for children": 19-20 (21) April 2012

Seminar 6 "Pharmacovigilance - Post-authorisation surveillance standards to meet regulatory requirements for product safety": 31-1 (2) June 2012

Seminar 7 "The roles of the supervising authorities and the essential characteristics of quality systems": 11-13 (14) July 2012

Seminar 8 "Scientific advice, regulatory strategy and health technology assessment": 29-31 (1) August 2012

Seminar 9 "Good Regulatory Affairs practice: communication skills, project management and tools for the daily practice": 11-12 (13) October 2012

The course will mainly take place in Freiburg, a town in the so-called Tuscany of Germany, located in the Southwest of Germany. Seminars 4.2 and 7 will take place in Strasbourg. These two cities are located in the three-country-corner France, Germany and Switzerland. Here you find accumulated pharmaceutical industry, research institutions and scientific excellence by the universities Freiburg, Basel and Strasbourg making this area a highly attractive region for life science industry and institutions. Seminar 4.1 will take place in Langen near to Frankfurt at the Paul-Ehrlich-Institut

Other locations might be arranged. The venue of each Seminar will be announced on the website www.eucraf.eu in due course prior to start of the individual Seminar.

The main course venue is in Freiburg the “Hotel Stadt Freiburg”, a modern, 4 star establishment with international standard. The hotel is positioned in a peaceful yet easily accessible location in direct proximity to the train station and the city centre of Freiburg. It provides modern and technically fully equipped air-conditioned conference rooms with internet access via wireless LAN. The hotel facilities and rooms are accessible by wheelchair.

The hotel rooms are modern and equipped with a kitchenette and wireless LAN. Non-smoking rooms can be booked. Car parking is available.

“Hotel Stadt Freiburg” offers a contingent of 4 star rooms at a special rate to all EUCRAF-course attendees. Further details are provided to each student upon confirmation of acceptance to the course.