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.
Selecting a Pharmacovigilance Drug Safety Database
Selecting a Pharmacovigilance Drug Safety Database The WHO defines pharmacovigilance (PV) as the science and activities related to detecting, assessing, understanding, and preventing adverse effects of a medicinal product or any other possible drug-related problems. A drug safety database is a...
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,...
Download – ABO Whitepaper
Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization, flexible resources, business...
What is Medical information and Communication?
It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies have transformed how we share information and interact with Healthcare Professionals and Patients. The advances in automation, digitization, real-world evidence & Big Data analysis...
Pharmacovigilance: latest news, trends, and insights
During the last years, there has been a skyrocketing demand for pharmacovigilance as medicinal products consumption is growing and disorders and diseases are becoming more prevalent. To top this, an increasing number of adverse drug reactions (ADRs) is becoming a significant concern leading to the...
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...
How To Improve Patient Recruitment In Early Phase Oncology Trials
The difficulties of recruiting in clinical trials, and particularly cancer patients in their early stages, can significantly obstruct the development of innovative treatments. There is an undeniable increase in demand for Early Phase Clinical studies in patients to enable informed decision-making....
What are the advantages of a hospital-based Early Phase Unit?
Choosing the right setting for your early phase trial can be challenging. As a sponsor, it's natural to remain cautious about running more extensive early-phase patient trials in a single Phase I unit due predominantly to the doubt over actually being able to recruit large patient populations....
Biomapas joins SwedenBIO organization
December 2021 Biomapas has joined the SwedenBIO organization starting November 2021. Joining SwedenBIO's mission to promote an environment bringing success and growth to the entire Swedish life science industry, we seek to walk the path in developing the life sciences sector. "Having participated...
What are the Challenges of Decentralized Clinical Trials?
The COVID-19 pandemic has accelerated the adoption of decentralized clinical trials by emphasizing the tangible advantages of virtual trials and their ability to improve the patient and physician experience. Moreover, it requires stakeholders to devote time and resources before reaping the...
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.
Marketing pharmaceutical products in CIS countries / Eurasion Union
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...
Medical Device Registration in Russia. The Essentials
Webinar: Successful Medical Device Registration in Russia. The Essentials The current national system for Medical Device registration in Russia was created from scratch and entered into force in 2013. Most experts agree that this system is complex and puzzling – some critical points are not well...
