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.
Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained in regulatory authority, academia and industry environments.
Anna’s senior positions in global pharmaceutical and health care industry in Russia and the UK included Procter & Gamble, EISAI, GSK as well as global CROs and consultancies PAREXEL, ICON and PRA. She is now an independent consultant.
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: