New requirements for medicine registration in the EU will improve global data exchange between pharmaceutical companies and regulators
June 14, 2021
November 09, 2020
Webinar: EAEU Regulatory Challenges and Opportunities
EXTEDO and Inpharmatis invite you to our joint complimentary webinar"Regulatory Challenges and Opportunities in the EAEU". |
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| In this webinar, we will discuss the regulations and requirements for electronic submissions in the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan) and show you, how EXTEDO and Inpharmatis can support you in getting your products on the EAEU market faster. | ||||||||||||||||||||||||||||||||||||||||||
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| Konstantin Koshechkin, the leading expert of the Russian Federation Health Authority will present experiences with EAEU submissions at regulatory agency level, expanding on recommended approaches and strategies for submissions. | ||||||||||||||||||||||||||||||||||||||||||
| EAEU expert Polina Dombure from EXTEDO's partner Inpharmatis will talk about the challenges when submitting electronic submissions in the EAEU countries. She will give useful hints on what needs to be considered when creating and validating these submissions and which regulatory strategy would help you in this region. | ||||||||||||||||||||||||||||||||||||||||||
| Maren Müller will demonstrate how EXTEDO's Word templates and the apps eCTDmanager and eSUBmanager could streamline your authoring and submission processes regarding the EAEU countries by offering compliant templates, automated processes and useful functionalities. | ||||||||||||||||||||||||||||||||||||||||||
| Following the presentation, the speakers will answer your questions in the Q&A session. | ||||||||||||||||||||||||||||||||||||||||||
Agenda:
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Новые требования к подаче сведений при регистрации лекарственных средств в Евросоюзе улучшат глобальный обмен данными между фармкомпаниями и регуляторами
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Inpharmatis принял участие в работе ПМЭФ-2021
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Inpharmatis appoints new RA Director in Russia & CIS
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Приведение досье в соответствие с правилами ЕАЭС
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Bringing the dossier in accordance with the rules of the EAEU
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Inpharmatis и «АКАДЕМФАРМ» обсудили в Минске перспективы сотрудничества
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Inpharmatis and “ACADEMPHARM” discussed in Minsk cooperation opportunities
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Participation in IPhEB Russia 2021
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