Successful Medical Device Registration in EAEU: New Legislation (Part 1)

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

Mikhail Vinogradov, LLM

Regulatory Affairs Project Manager Biomapas

Other content that might interest you:

Building Health Literacy: The Value of Good Writing

Building Health Literacy: The Value of Good Writing

Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.

read more
CMC: Down the road in effective IND/IMPD writing

CMC: Down the road in effective IND/IMPD writing

In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing particulars giving some key messages on document preparation. Now, we will discuss other important points. These are safety, data completeness, and geographical regions.

read more
Running a Clinical Trial in Ukraine

Running a Clinical Trial in Ukraine

Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.

read more
What You Need to Know about Running a Clinical Trial in Russia?

What You Need to Know about Running a Clinical Trial in Russia?

Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).

read more

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information