A comprehensive In-house course of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
The aim of this In-house course is to provide a comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. This interactive meeting will discuss the regulatory requirements within these regions. The focus will be on practical aspects to assist in developing your regulatory strategy for product approval in these countries. The presentations will also give practical hints on the regulatory and registration process where possible.
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Russia – the competitive landscape
CIS – Regional regulatory overview
Eurasian regulations for medical devices
Registration of medical devices in CIS
Alex Dranov, M.D.R.A., is a native Russian speaker who was born in Ukraine. After graduating with honours in Biology/Biochemistry from Charkiw’s State University, he worked as a scientific employee at different pharmaceutical companies. Alex further enhanced his educational background by graduating in Business Administration from the University of Hagen and in Drug Regulatory Affairs with a Master’s degree (M.D.R.A.) from the University of Bonn. He has more than 20 years of regulatory experience in the pharmaceutical industry in Germany and Eastern Europe. Alex has managed multiple projects in the fields of regulatory affairs and product development. In 2010, he joined the International Division of Dr. Willmar Schwabe Pharmaceuticals, Germany, as a Senior Regulatory & Scientific Affairs Manager responsible for regulatory activities in and outside the EU, especially in Eastern European countries (Russia, Ukraine and CIS, among others), the Middle East and India.