Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you towards a successful submission strategy development.

As of now, all national medicinal product marketing authorizations are valid in EAEU until their expiry date. However, the mentioned marketing authorizations must be revalidated according to the EAEU regulations until December 31st, 2025.

Preparing for a marketing authorization upgrade?

Make use of our experts to create a successful submission strategy development. Explore your options in an informal chat with one of our experts.

You will learn:

What do you need to prepare and implement now to timely and successfully transition to the EAEU marketing authorization?

  1. What are the main points you need to consider when going into the upgrade procedure?
  2. What do you need to know about EAEU GMP certification?
  3. What are the readability user testing requirements?
  4. Timelines

Who Should Attend?

Professionals from the following fields:

  • Regulatory Managers
  • Regulatory Strategy Managers
  • RA Partnerships Operations Manager
  • QA Managers supporting RA
  • RA Healthcare Compliance Managers

Duration: 25 min.

Speaker: Head of Global Regulatory Affairs, Olga Bernardova, MSc, who will share her expertise regarding eCTD submissions.

Nargiz Asgarova

Nargiz Asgarova

Regulatory Affairs Project Manager CIS

View the webinar.

Other content that might interest you:

Download – ABO Whitepaper

Download – ABO Whitepaper

Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...

read more
What is the Clinical Trials Regulation?

What is the Clinical Trials Regulation?

The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the...

read more

Recent Insights

Learn from Biomapas' experts and let us know what you'd like to hear about!

Challenges in early phase oncology trials
Clinical Trials Regulation
Challenges in early phase oncology trials