Course description
Gaining Marketing Authorisations In CIS For Medical Devices
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.
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Suitability - Who should attend?
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
Outcome / Qualification etc.
Gaining Marketing Authorisations In CIS For Medical Devices
Training Course Content
- 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.
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5