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!
Upcoming Webinars
Feel free to join any of our upcoming webinars. Our experts share their field experience regularly and our webinars are an excellent occasion to bring your questions up for discussion.
Rather read in your own time? Try a few of our blogs on:
Oncology Study Design
Join us for a must-attend webinar on “Exploring Oncology Clinical Trial Design”, where expert speakers will share the latest insights.
National differences for Pharmacovigilance in Europe
Join our webinar on “Navigating National Differences in Setting up a Pharmacovigilance System in Europe.” 🇪🇺 💊
Oncology Study Design
Join us for a must-attend webinar on “Exploring Oncology Clinical Trial Design”, where expert speakers will share the latest insights.
National differences for Pharmacovigilance in Europe
Join our webinar on “Navigating National Differences in Setting up a Pharmacovigilance System in Europe.” 🇪🇺 💊
Let’s celebrate success
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new countries all around the globe and the...
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...
Let’s celebrate success
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new countries all around the globe and the...
Clinical Trial Design For Early Phase Oncology Studies
Designing effective early-phase oncology trials is a complex and challenging task, requiring careful consideration of various factors, including patient selection, dosing, safety monitoring, and endpoint selection. In addition, developing targeted therapies has brought new challenges and...
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...
Let’s celebrate success
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new countries all around the globe and the...
The Role of Regulatory Intelligence in Pharmacovigilance
Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It's so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly. What Is Regulatory Intelligence? Regulatory Intelligence is...
Q&A. How does the conflict between UA & RU impact the pharma industry?
Webinar: How does the conflict between UA & RU impact the pharma industry? Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And with good reason. Russia's invasion of Ukraine affects millions of people, not...
How does the Russian invasion impact the pharmaceutical industry?
Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And, with good reason. Russia's invasion of Ukraine affects millions of people, not just in this Eastern European nation but throughout the world. As a result,...
Smooth Switch to the EAEU Marketing Authorization for Medicinal Products
Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you towards a successful...
Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation
There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent advancements, one of which is the...
