How to register a Medical Device in the EAEU
Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: a new regional registration system for medical devices is coming into effect from the start of 2022. As most registrations are completed through national...
How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?
Webinar: How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs? Affiliate-Based Outsourcing (ABO) Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources, which are often insufficient...
Setting Up A Pharmacovigilance System
Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product’s Market Authorization Application (MAA). A robust pharmacovigilance (PV)...
