Insights & Resources. For Life Sciences Professionals.
Whether you’re a healthcare professional, a researcher, or simply interested in the drug development, you’ll find valuable information and resources here that can help you stay informed and make informed decisions. Let us know what else you’d like to hear about!
National differences for Pharmacovigilance in Europe
Join our webinar on “Navigating National Differences in Setting up a Pharmacovigilance System in Europe.” 🇪🇺 💊
National Differences in Pharmacovigilance Requirements in Europe
Pharmacovigilance requirements in Europe are primarily governed by the European Medicines Agency (EMA) through the EU Regulation on Pharmacovigilance (Regulation (EU) No 1235/2010). However, some national differences in implementing and enforcing these requirements may exist. These differences...
A History of Pharmacovigilance
Pharmacovigilance, also known as drug safety surveillance, is the process of monitoring, identifying, and assessing medicinal products' potential risks and benefits. It is an essential part of ensuring the safety and efficacy of drugs for patients and healthcare providers. If we're approaching the...
Developing a Safety Management Plan (SMP) for Pharmacovigilance
Developing a Safety Management Plan (SMP) What is the Safety Management Plan (SMP)? This article explores all you need to know about the SMP for Pharmacovigilance and how you develop it. A Safety Management Plan (SMP) is a critical component of a comprehensive pharmacovigilance program. It...
EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?
European Medicines Agency (EMA) and Food and Drug Administration (FDA) are regulatory bodies working in Europe and the United States of America, respectively, with their own approached to risk management procedures. They both aim to promote and protect public health and ensure compliance with high...
How to set up a pharmacovigilance system?
Webinar: Setting up a pharmacovigilance system in Europe. Where to start? What to consider? Setting up a pharmacovigilance system is not as straightforward an answer as it may sound. There are many aspects to consider, which can seem complicated, especially when you must focus on developing your...
Oncology Study Design
Join us for a must-attend webinar on “Exploring Oncology Clinical Trial Design”, where expert speakers will share the latest insights.
Oncology trials in a shifting economical and geopolitical landscape
Webinar: Oncology trials in a shifting economical and geopolitical landscape The pharmaceutical and biotech fields are spinning around, seeking to adapt to the current geopolitical situation and its impact on current and future oncology trials. Many trials have been shifted to other countries or...
Running Clinical Trials in Eastern Europe
It has become common practice for pharmaceutical companies to run clinical trials in Eastern Europe. However, it is also a common misconception that Eastern European countries only offer the lowest cost of operations as a benefit. This article shares insight into what factors you should consider...
All You Need To Know About Clinical Trials
So you want to improve your Clinical Trial expertise? Great! This field is snowballing and offers many opportunities for those with a suitable skill set. But before you dive in, it's essential to know what clinical research is all about. This article gives you a rundown of the basics with options...
Selecting A CRO For An Early Phase Oncology Trial
As oncology drug developers, you likely know that selecting the proper Contract Research Organization (CRO) for your Phase 1 clinical trial is a crucial step in bringing your treatment to the market. This article provides insights for oncology drug developers when selecting a CRO for an Early...
How Do Early Phase Oncology Trials Evolve?
In the last few years, a major breakthrough in cancer research has occurred: early phase oncology trials. This type of trial is designed to test whether a new drug has any adverse effects on people and also provides anecdotal evidence that it might be efficacious. This blog post will discuss the...
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)
Drug registration in the EAEU: Learn about pathways for market authorization, the CTD format, and approvals in the Eurasian Economic Union.
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...
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...
