Marketing Authorisation in the CIS and MENA Countries
Curso
En Madrid
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Descripción
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Tipología
Seminario
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Lugar
Madrid
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Duración
2 Días
Objetivo del curso: Seminario más exitoso de FORUM Institut für Management (Alemania). Durante el seminario tendrá la posibilidad única de obtener la "first hand" información de expertos de países como Rusia, Ucrania, Turquía, Saudí Arabia etc, resolver cualquier duda sobre estos mercados cada vez más importantes y sofisticados. DUE TO THE PRESENCE OF FOREIGN SPECIALISTS THIS SEMINAR IS HELD IN ENGLISH. Dirigido a: Dpto de los asuntos regulatorios, I+D, director de desarrollo del negocio.
Instalaciones y fechas
Ubicación
Inicio
Inicio
A tener en cuenta
Certificado de asistencia otorgado por QualitecFarma y FORUM Institut
Opiniones
Materias
- Marketing farmacéutico
- Director de seguridad
Profesores
Dr. Edelgard Rehak
Consultant for Drug Regulatory Affairs Eastern Europe, Maring
Dr. Rehak acts as consultant for pharmaceutical companies to register medical products in Russia and in the CIS countries and to find local distributors. Until 2009 Dr. Rehak was Head DRA CIS Cluster at NOVARTIS Pharma in Kiev. .
Dr. Mohammed Saleem
Boehmert & Boehmert, Representation Office Middle East and North Afric
General Director of Science-forum for Intellectual Property & Industrial Service. Senior consultant to many UN organisations and in projects from the World Bank, UNDP and WHO. Head of the IPR comittee at the Jordan FDA and head of the LES-AC "Life science committee".
Dr. Raimond Lozda
Director at FMS Baltic Ltd., Riga, Latvia.
Dr. Lozda has intensive experience in Regulatory affairs. Since 2002 he is working as an independen tconsultant covering assistance for MA applications in Russia, Ukraine, Belarus and Baltic States.
Dr. Rula Ghazi Kawar
Head of Pharmaceutical service office "Apex Pharmaceutical Services" J
11 years of experience in drug regulatory affairs: Middle East Region at Ferring Pharmaceuticals and a local drug store as regulatory affairs manager working with Abbott , Stiefel, Pharmaton etc. Currently Head of Pharmaceutical service office "Apex Pharmaceutical Services" covering regulatory services for local and multinational companies in the Middle East Area.
Temario
Day 1, mena countries
focus: saudi arabia, jordan & maghreb
- political change and impact on mena regulatory authorities
- market entry middle east
- update on the regulatory requirements
- comparative dossier regulatory requirements
- sample marketing authorizations (examples for different countries)
day 2, cis countries
focus: russia, belarus, ukraine, kazakhstan
- structure and working procedures of the national authorities
- the application dossier
- the application procedure
- maintenance of the marketing authorisation
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Marketing Authorisation in the CIS and MENA Countries