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!
Clinical Trial Diversity
Why is diversity in clinical trials so important, and what challenges does the industry face in achieving it? Explore ethical considerations, practical hurdles, and recent guidelines from the FDA and EMA in our latest article by Jan Filakovsky, CEO of Biomapas.
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...
How can a CRO support Mergers & Acquisition
The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years due to the growing number of...
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...
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...
