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.
Advantages of QPPV Outsourcing in the EU/EEA
Advantages of QPPV Outsourcing in the EU/EEA Pharmaceutical companies with a primary base outside the EU, companies without in-house PV capabilities or companies with business decisions to refocus their workload on core strategic competencies often look to externalize these crucial activities....
Affiliate Based Outsourcing for Regulatory Affairs
Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.
7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy
Choosing the right set of countries, sites and investigators for a clinical trial are critical success factors in any clinical development program. They can guarantee speedy patient recruitment and timely delivery of study results. It also ensures that you conduct your clinical trial within budget...
Company Registration Requirements in MENA: a Prerequisite for Product Registration
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 international GMP...
Biosimilars in the MENA Region: Regulatory Landscape
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 global agencies, e.g., WHO, MHRA,...
Successful Medical Device Registration in EAEU: New Legislation (Part 1)
Watch the on-demand webinar replay: 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...
Saudi FDA’s New Pricing Guidelines and Impact on the Region
In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.
CIS and Eurasian Economic Union: High Pharma Industry Interest And New Legislation
The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs, pharmacovigilance. Head of Business...
Regulatory Strategy in the EAEU and rest of CIS Countries
Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries Regulatory strategy in EAEU and CIS regions differ from other regions as market access to these countries can be a real challenge due to various local regulations. However, it is only a matter of experience and adequate know-how....
CMC: Effective Writing Of IND And IMPD
This artical focuses on best practices in delivering an effective CMC writing strategy when writing an IND or IMPD.
Effective IMPD Writing. The Quality Part
Webinar: Effective IMPD Writing. The Quality Part Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent...
