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!
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...
Role of the Local Person for Pharmacovigilance (LPPV)
The EU changes on the regulatory side have been significant. It has not only seen pharma companies face a new challenge to meet the requirements but also regulated medicinal products manufacturers, distributors and Pharmacovigilance professionals. The Local Person for Pharmacovigilance (LPPV) is...
All You Need To Know About Pharmacovigilance
Pharmacovigilance is the process of monitoring the safety and effectiveness of medications. The term was introduced in the early 1970s and evolved to include a broader range of activities. It's vital to ensure that patients have access to safe and effective drugs and that manufacturers make the...
Artificial Intelligence in Pharmacovigilance
Automation & AI in Pharmacovigilance: Promises and Realistic Expectations Recent years have seen increasing pharmaceutical companies' pharmacovigilance (PV)-related activities. The promise of artificial intelligence (AI) and automation is often mentioned as a way to meet the increasing PV...
Pharmacovigilance Opportunities in the MENA Region
Webinar: Pharmacovigilance Opportunities in the MENA Region Pharmacovigilance is getting more and more attention in MENA countries thanks to new regulations and steps in the right direction. The MENA region itself holds great promise for the pharmaceutical industry, being potentially hugely...
Pharmacovigilance in the MENA Region
This blog focuses on pharmacovigilance (PV) in the MENA Region; the Middle East and North Africa. We do this by comparing the MENA region and Europe and inter-country differences in the MENA region. Local legislation and requirements will be discussed, such as requirements on periodic safety...
Running A Clinical Trial In Georgia
Moving Clinical Trials away from Ukraine and Russia Russia, Ukraine, and other CIS countries have been significant contributors to clinical trials in many therapeutic areas for several years. With access to experienced investigators, good quality, and large patient populations, we could often...
Running A Clinical Trial In Kazakstan
Moving Clinical Trials away from Ukraine and Russia For a long time, Russia, Ukraine and other countries in the Commonwealth of Independent States (CIS) have been the host of ample clinical trials in various therapeutic areas. And for a good reason: countries in the region provide access to large...
How to Avoid Delays in Your Early Phase Oncology Trial?
Webinar: How to Avoid Delays in Your Early Phase Oncology Trial? Many things can go array in your early phase oncology trials, from protocol development, taking care of a safety profile, getting the ethics committee / regulatory authority’s approval, managing vendors, and much more. They all cost...
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,...
How To Manage An Early Phase Oncology Study: Project Manager Insights
Clinical development of oncology drugs has one of the lowest success rates of the development of Investigational New Drugs (INDs) for all disease categories, with less than 7% of phase I-tested oncology drugs achieving market approval. Moreover, the clinical development time for medicinal oncology...
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...
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.
Affiliate Based Outsourcing for Regulatory Affairs
Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.
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)
Webinar: 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 the EAEU system, current...
