With recent regulatory developments for medical devices in Russia, Ukraine and other CIS countries it is essential to remain up-to-date to ensure speedy authorisation.
This intensive, highly interactive 2-day course examines the medical device regulations, providing you with the latest updates on the regulatory processes for gaining marketing authorisation in the CIS, including registration procedures, timelines and fees plus key considerations for labelling requirements, regulatory maintenance and PMS.
The course will explore all the key CIS countries such as Russia, Ukraine and Belarus providing you with the skills to successfully gain authorisation of devices.
Using a combination of theory and practical case studies, the course will journey from country to country providing delegates with a complete guide to the CIS for medical devices.
Edelgard Rehak has more than 20 years’ experience in the development and registration of medicinal drug products and medical devices. Her speciality areas are Russia and the CIS.
From 2012 to 2015, Edelgard worked as Medical Director for Zentiva, a Sanofi company, and later as Head of Registrations for Sanofi, based in Moscow. Previously, she worked as the Head of Registrations for the CIS for Novartis in Kiev. In 2010, Edelgard established her own consultancy and now delivers consultancy and training for clients wishing to enter the Russian and/or CIS markets.
This course is suitable for professionals working in, have affiliate offices in or are thinking of expanding in the Russia/CIS region. It is aimed at those operating in the medical device industry working in the areas of: