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Gaining Marketing Authorisation in the CIS for Medical Devices

2 - 3 December 2019

Le Palais Art Hotel Prague

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.

Dr Edelgard Rehak

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:

  • 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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