Marketing Authorization Process in Russia
Cultural and language problems are a frequent stumbling block for multinational corporations seeking to register drugs in Russia. Additionally, the Marketing Authorization process in Russia is highly complex, and the paperwork frequently changes as the regulatory framework evolves. However, the...
Drug Registration in Russia
Overview of drug registration in Russia The Russian pharmaceutical industry is expected to exceed two trillion Russian rubles in 2020, representing a roughly 10% growth over the previous year. Pharmaceutical revenues are expected to reach 2.35 trillion Russian rubles by 2023. It's also worth...
What is Medical information and Communication?
It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies have transformed how we share information and interact with Healthcare Professionals and Patients. The advances in automation, digitization, real-world evidence & Big Data analysis...
Preparing for the 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 local regulatory resources, which often do not fully fulfil the needs for the effective organization, flexible resources, business continuity, cost optimalization and...
Drug Registration in the Eurasian Economic Union (EAEU)
If you are interested in marketing your medicinal product in the fast-growing pharmaceutical market of the Eurasian Economic Union (EAEU) and if you want to how to apply for market authorization in the EAEU, this blog post is for you. The first part of this article describes why the EAEU is an...
Biomapas Nordic AB Appoints Ola Jeppsson to CEO & Business Development Director
August 2021 Ola Jeppsson has taken on a leading role as Business Development Director. In addition to his new role, he was appointed as a Chief Executive Officer at Biomapas Nordic AB starting August 2021.Having a management and business development background in the life sciences industry, he...
Marketing Authorization Renewal in the MENA Region
Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization Approval certificate of pharmaceutical products that ranges between four to five years in most countries. The purpose behind this license validity period is to enforce the regulation...
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 procedures, the upcoming...
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 for the effective organization and...
Pharmacovigilance: latest news, trends, and insights
During the last years, there has been a skyrocketing demand for pharmacovigilance as medicinal products consumption is growing and disorders and diseases are becoming more prevalent. To top this, an increasing number of adverse drug reactions (ADRs) is becoming a significant concern leading to the...
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) system consists of a safety...
Centralized Procedure in the GCC Region
The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products throughout the region. The Cooperation Council for the Arab States of the Gulf, abbreviated as "GCC" for "Gulf Cooperation Council", came to exist on May 25th, 1981. The founding Member States...
Must-Know Legislation for Medical Device Registration in the EAEU
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 Union" to create a single regional...
Strategic Pharmacovigilance Activities. Scalable and Tailor-made Outsourcing Models
Webinar: Strategic Pharmacovigilance Activities. Scalable and Tailor-made Outsourcing Models Larger companies often limit their strategic pharmacovigilance activities outsourcing only to highly manual and repetitive tasks, while the smaller ones may want to outsource their entire pharmacovigilance...
Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)
How do you realize Medical Device Registration in the Eurasian Economic Union (EAEU)? Learn about EAEU Conformity Assessment Routes and MRP.
