New requirements for medicine registration in the EU will improve global data exchange between pharmaceutical companies and regulatorsJune 14, 2021
eRA 2019 Conference with CIS Region Partner Meeting in Munich
We had a pleasure to spend two intensive days in the eRA 2019 Conference which was held in Munich this year.
Since 2006 the e-Regulatory Affairs conference, more commonly known as just eRA, has provided a unique learning and networking opportunity for regulatory affairs professionals from around the globe. And this year was no exception. With the Conference theme “Regulatory Information Management in the era of globalization” 20 leading experts from industry and regulatory authorities shared their experiences and knowledge.
The Conference took place at the beautiful Eurostars Grand Central Hotel from 22nd to 23rd May.
This year for the first time happened CIS region Partners meeting.
At a special session for the CIS countries, Health authorities and leading industry experts introduced with all the innovations in regulatory matters relevant to companies operating in the EU and CIS markets.
Health authority and leading expert Konstantin Koshechkin shared his knowledge not only at the conference’s main session but also at a special session for the CIS countries. His area of expertise lies at the junction of IT and pharmaceuticals. Konstantin Koshechkin takes part in the implementation of a number of projects of the Ministry of Health of the Russian Federation related to the automation of document flow and certification, the improvement of the system for evaluating information on the safety of medicines, the validation of pharmaceutical information systems, etc. With brilliant presentations, all the participants had the opportunity to learn the algorithm for the formation of a dossier in electronic form and how to prepare for the transition to eCTD.
Also, a representative from the Center for Examinations and Tests in Health Service State Enterprise of Belarus Tatiana Shamstudinova with impressive presentation introduced us with features of the execution of national registration procedures in the Republic of Belarus and their comparison with the requirements of the EAEU.
Anvarbek Moldotashov, an expert of the Department of Provision and Medical Equipment under the Ministry of Health, told about the present and future of e-regulation of the pharmaceutical market of Kyrgyzstan.
The expert of the Scientific Center of Drug and Medical Technology Expertise Narek Baghdasaryan shared the specifics of the registration of medicines in the sunny Republic of Armenia.
And Taras Lyaskovsky, representing the Ministry of Health of Ukraine, informed about the nuances of the drug registration system in the Ukrainian market.
The conference brought together leading experts in the implementation of electronic standards in different countries, led by the leader in the development of IT systems for managing regulatory information - the company EXTEDO.
During the conference, all participants and speakers had a chance to know the policymakers in the pharmaceutical industry, make useful connections, learn about the experience of implementing information systems and new IT products that simplify the process of e-registration of drugs. Our Inpharmatis team spent both conference days meeting with eCTD developers and users. Meeting with Health authorities and leading experts from industry and regulatory authorities we have enhanced our knowledge and abilities. And we are ready to give it to you!
Inpharmatis, the organizer of the session for the CIS countries, warmly thanks the speakers and all the participants! See you at the next events!
Meet the future today and implement eCTD now!
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