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