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Gaining Marketing Authorisation in the CIS for Medical Devices

11 - 12 April 2018

Radisson Blu Edwardian Grafton, London

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.

  • Learn about recent regulatory changes in Russia and Ukraine to ensure you are prepared before applying for device authorisation
  • Explore the complicated approval process in the CIS region
  • Discover business opportunities and challenges of the regional medical device market
  • Understand regional and national systems of standards for medical devices
  • Overcome medical device registration procedures and post-marketing requirements in Russia, Ukraine, Kazakhstan, Belarus and CIS markets.

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.

Interview with Anna on latest regulatory challenges and developments in Russia and the CIS

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:

  • Regulatory affairs
  • Regulatory operations
  • International regulatory affairs
  • Global regulatory operations
  • Dossier management
  • Information management

Medical devices software development and applications

Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 

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