Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1)
The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and compares the EAEU system, current national registrations, and EU Medical Device Regulation (MDR).
This webinar focuses on learning:
1. EAEU Legislation on Medical Device registrations
- Legislation structure and comparisons
- Safety and Performance requirements
- Transition period updates
2. EAEU Registration Dossier
- Dossier structure and new changes
Eurasian system for medical device registration will come into force on January 1st, 2022, and will fully replace all national systems of the EAEU member states.
Registering Your MD In The EAEU?
Make use of our experience to facilitate the approval process. Explore your options in a chat with one of our experts.
Who should attend?
Professionals working in the following fields:
- Regulatory
- R&D
- QA/QC
- Compliance
- Product Development
- Manufacturing
Duration: 50 minutes
Speaker: Mikhail Vinogradov, Regulatory Affairs Project Manager
Mikhail Vinogradov, LLM
Regulatory Affairs Project Manager Biomapas
Other content that might interest you:
Proper Publicizing in CEECs – Path to Successful Social Media Commercials
With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.
How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?
It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments for such transitions. The value for M&A in the pharmaceutical sector was $221 billion in the first half of the year 2015. In 2019, the worth of pharma companies M&A activities have reached $357 billion.
CMC: Best Practice in Effective IND and IMPD writing
This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.
