by Kamile Gruduls | Jun 17, 2021 | Medical Devices, Regulatory Affairs
EAEU legislation for Medical Device registration has been continuously updating for the last six years since the Eurasian Economic Union, otherwise known as EAEU, was entered into force in 2015. Five countries have signed the “Treaty on the Eurasian Economic...
by Nick | Jun 9, 2021 | Regulatory Affairs, Webinar
Webinar: Medical Device Registration in the Eurasian Economic Union (EAEU) The webinar on Medical Device Registration in the Eurasian Economic Union (EAEU) reviews the practical aspects of the approval procedure. We will discuss the various stages of the registration...
by Nick | May 25, 2021 | Regulatory Affairs, Webinar
Webinar: Affiliate Based Outsourcing for Regulatory Affairs Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as...
by Kamile Gruduls | May 12, 2021 | Regulatory Affairs
Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture. MENA countries are accepting...
by Kamile Gruduls | Apr 27, 2021 | Regulatory Affairs
Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...
by Nick | Apr 2, 2021 | Regulatory Affairs, Webinar
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...
