Pharmacovigilance Update
Nueva Regulación Europea a partir de 2012
Pharmacovigilance Update
07.02.2012 / Madrid
Pharmacovigilance Update[more]
07.02.2012 / Madrid
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Variations Conference
Variation application & procedures
Variations Conference
28.02.2012 / Köln
International conference on the Variations Regulation (grouping, worksharing), the impact of the pharma package and variations in the eCTD format[more]
28.02.2012 / Köln
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Variations Conference
Quality related variations
Variations Conference
29.02.2012 / Köln
Quality related variations - classification, design space possibilities and the new task "post approval change management protocols"[more]
29.02.2012 / Köln
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mAb Biosimilars 2012
Monoclonal antibodies as biosimilars
mAb Biosimilars 2012
01.03.2012 - 02.03.2012 / Frankfurt
Seminar regarding the new guideline on similar biological medicinal products containing monoclonal antibodies[more]
01.03.2012 - 02.03.2012 / Frankfurt
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Marketing Authorisation in the Middle East, Africa, Turkey, Australia and New Zealand
Marketing Authorisation/Arzneimittelzulassung im Nahen Osten, Afrika, Türkei, Australien, Neuseeland
Marketing Authorisation in the Middle East, Africa, Turkey, Australia and New Zealand
05.03.2012 - 07.03.2012 / Frankfurt
Current challenges in regulatory affairs - addressed by experts with local know how[more]
05.03.2012 - 07.03.2012 / Frankfurt
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Regulatory Affairs India
Marketing Authorisation in India/Arzneimittelzulassung in Indien
Regulatory Affairs India
14.03.2012 / Frankfurt
Current challenges in regulatory affairs - addressed by experts with local know how[more]
14.03.2012 / Frankfurt
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Regulatory Affairs China
Marketing Authorisation in China/Zulassung in China
Regulatory Affairs China
15.03.2012 / Frankfurt
Current challenges in regulatory affairs - addressed by experts with local know how[more]
15.03.2012 / Frankfurt
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Il Time to Market di un medicinale
Attività, pianificazione e responsabilità delle funzioni aziendali coinvolte
Il Time to Market di un medicinale
03.04.2012 / Milano
Il Time to Market di un medicinale[more]
03.04.2012 / Milano
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English writing and reviewing in regulatory affairs
Package leaflet and further documents
English writing and reviewing in regulatory affairs
18.04.2012 / Frankfurt / Offenbach
Seminar on writing, editing and proofreading of regulatory documents[more]
18.04.2012 / Frankfurt / Offenbach
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FDA: Marketing Authorisation in the USA
Update on the IND, NDA & BLA procedures
FDA: Marketing Authorisation in the USA
25.04.2012 / Köln
Details on the FDA drug registration and communication with the authority[more]
25.04.2012 / Köln
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ExpertFORUM Labeling/Product information
1st day: Product information - challenges for 2012
ExpertFORUM Labeling/Product information
07.05.2012 / Bonn
International FORUM Conference on the current challenges with regard to labeling + SmCP[more]
07.05.2012 / Bonn
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ExpertFORUM Labeling/Product information
2nd day: Electronic submission of the product information - XEVPRM
ExpertFORUM Labeling/Product information
08.05.2012 / Bonn
Seminar with detailed information on EVMPD and XEVPRM - THE task for 2012!
[more]
08.05.2012 / Bonn
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Marketing authorisation in Japan
Drug marketing authorisation in Japan - MHLW, PMDA, KIKO
Marketing authorisation in Japan
14.05.2012 / Frankfurt
Marketing authorisation in Japan - the precondition for a successful market access[more]
14.05.2012 / Frankfurt
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Marketing Authorisation in the CIS Countries
Focus: Russia/Russland, Belarus/Weißrussland, Ukraine, Kazakhstan
Marketing Authorisation in the CIS Countries
27.08.2012 / Berlin
Regulatory Affairs Know how - here you can discuss with local experts![more]
27.08.2012 / Berlin
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Marketing Authorisation in the Balkan States
Croatia, Montenegro, Macedonia, Bosnia, Serbia & Kosovo
Marketing Authorisation in the Balkan States
04.09.2012 / Frankfurt
Seminar on the regulatory requirements in Croatia, Montenegro, Macedonia, Bosnia, Serbia + Kosovo[more]
04.09.2012 / Frankfurt
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Successful Medical Writing
Successful Medical Writing
25.09.2012 - 26.09.2012 / Frankfurt
In-depth training in general writing and data presentation skills, and specifically in the kinds of documents most frequently
encountered in clinical research.[more]
25.09.2012 - 26.09.2012 / Frankfurt
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Marketing Authorisation in Asia
China, Hong Kong, Indonesien, Singapur, Thailand, Korea, Malaysia, Philippinen, Vietnam, Taiwan
Marketing Authorisation in Asia
17.10.2012 - 18.10.2012 / Frankfurt
Update on the regulatory framework in Asia with a focus on China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam.[more]
17.10.2012 - 18.10.2012 / Frankfurt
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