“The ERA course not only provides deep insight into the basics of regulatory affairs, it also brings forward the views of different stakeholders on the challenging and constantly changing regulatory environment. The content of the course, which goes far beyond the content of regulations, directives and guidance, is not static, but changes along with the regulatory landscape to allow for “up to date” discussions. As course participants are often a mixture of representatives from regulatory agencies and industry, the ERA course should therefore be seen as a dynamic, interactive learning and discussion platform.” European Regulatory Affairs Course (Mr. F. Van Dyck, PhD Janssen Infectious Diseases BVBA, course participant 2011) SIR Institute for Pharmacy Practice and Policy Theda mansholtstraat 5b 2331 JE Leiden The Netherlands 0031 (0)71 576 61 57 [email protected] www.stevenshof.nl “The ERA course gives you a very good perspective of all the aspects concerning the European registration of medicinal products for human use. The combination of the presentations, the casestudy and the discussions, give you a good overview. In addition, there is also enough time for socializing because during the five modules you eat and sleep in the same hotel.” (Mrs. K.F.J. van Beurden , VSM Geneesmiddelen BV, course participant 2012-2013) March 2014 - November 2014 Dear Sir/Madam, Course data 2014 The programme is divided into five modules, each lasting three days: Module I Module Module Module Module II III IV V Examination Introduction to EU drug regulatory affairs (5 - 7 March 2014) Quality (2 - 4 April 2014) Non-clinical reports (11 - 13 June 2014) Clinical reports (17 - 19 September 2014) On the edge of pre- and post-marketing (12 - 14 November 2014) To be announced Location Module I will take place in the vicinity of the EMA in hotel Hilton Docklands London, United Kingdom. The venue for the remaining four modules (module II-V) will be Hotel Kasteel Oud Poelgeest in Oegstgeest, The Netherlands (www.oudpoelgeest.nl) Official Language The official language is English (no simultaneous translation) Registration The course fee is Euro 7195,-- that is exempt from VAT or BTW. You are invited to register through our website www.stevenshof.nl. Early registration is recommended, as the number of participants will be limited. Hotel Accommodation Hotel expenses for each module, including two overnight stays, luncheons, dinners and accommodation, will approximately be Euro 500,--. The course manager will arrange hotel accommodation upon request. The well-known and high standard SIR European Regulatory Affairs (ERA) course has been designed to cover all aspects of regulatory affairs. The course is highly interactive with leading personalities from industry, academia and regulatory bodies, offering expert knowledge with practical exercises and casestudies. The course is designed for professionals who need to familiarise themselves with the full range of administrative, technical and scientific EU requirements. Opportunities will be provided for the information and insight to be applied directly to the participant’s scientific, industrial or governmental organisation. Participants will preferably have previous university training in the biomedical or related disciplines, such as medicine, pharmacy, biochemistry, pharmacology and toxicology. Considered a great success over the past years, the SIR ERA course is viewed by leading authorities as an established learning vehicle for professionals in regulatory affairs, both in industry and government. Whether you need a good regulatory and scientific knowledge base on which to build, or you wish to update your European regulatory affairs experience this course will perfectly match your needs! For more information or registration please visit our website: www.stevenshof.nl or send an email to [email protected]. We look forward to welcome you as participant. Kind regards, also on behalf of the Chairman, Dr H. van Bronswijk, Mrs. T.M. Bakker-Krol Course Manager Faculty 2014 Dr A. Benbow Kinapse Ltd. Dr E.H.E. Biesheuvel Merck Sharp & Dohme Prof. dr H. Blume SocraTec R&D Dr H. van Bronswijk Parexel Consulting Prof. dr M.L. Bouvy Utrecht University Prof. dr A.F. Cohen Leiden University Dr D.J. v.d. Dobbelsteen Synthon BV Dr S. Driessen Abbott Prof. dr P.A. de Graeff Groningen University Dr C. Herberts Dutch Medicines Evaluation Board Dr J. Hulshof Simon-Kucher & Partners Dr J. Janssen TI Pharma Dr D.B. Jefferys Eisai Europe Ltd. Mrs. A.G. Kruger Dutch Medicines Evaluation Board Drs. M.E. Kubbinga Dutch Medicines Evaluation Board Dr A. Lampo Janssen R&D Dr J.F.F. Lekkerkerker NDA, Advisory Board Member Prof. dr H.G.M. Leufkens Utrecht University Dr N. McAuslane CMR Drs. D.A. van Riet-Nales Dutch Medicines Evaluation Board Em. Prof. dr G.J. Mulder Leiden University Prof. Dr T. Paal GYEMSZI, University of Szeged Em. Prof. dr P.W.J. Peters University Medical Centre Utrecht Dr Ir. P.J.M. Reijnders Consultant Regulatory Affairs Dr K. Rose klausrose Consulting Dr A.P. Sam Merck Sharp & Dohme Dr F. Sauer European Commission Prof. dr H. Schellekens Utrecht University Dr H.F. Schuring Genzyme Europe BV Dr B. Teeuw Astellas Pharma Europe BV Dr R.G.L. van Tol Astellas Pharma Europe BV Dr L. Vromans Merck Sharp & Dohme Dr P. Walstra Astellas Pharma Europe BV