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!
Setting Up A Pharmacovigilance System
Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product's Market Authorization Application (MAA). A robust pharmacovigilance (PV) system consists of a safety...
Strategic Pharmacovigilance Activities. Scalable and Tailor-made Outsourcing Models
Webinar: Strategic Pharmacovigilance Activities. Scalable and Tailor-made Outsourcing Models Larger companies often limit their strategic pharmacovigilance activities outsourcing only to highly manual and repetitive tasks, while the smaller ones may want to outsource their entire pharmacovigilance...
Advantages of QPPV Outsourcing in the EU/EEA
Advantages of QPPV Outsourcing in the EU/EEA Pharmaceutical companies with a primary base outside the EU, companies without in-house PV capabilities or companies with business decisions to refocus their workload on core strategic competencies often look to externalize these crucial activities....
3 Factors Affecting the Successful Collection of Drug Safety Information in Social Networking Sites
Health information that has been posted online by patients can efficiently supplement your post-marketing drug safety data gained from traditional sources. Data harvesting from Social Networking Sites (SNS) has a lot of potential and significant advantages when compared to traditional sources. A...
Building Health Literacy: The Value of Good Writing
Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.
Proper Publicizing in CEECs – Path to Successful Social Media Commercials
With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.
What is the Clinical Trials Regulation?
The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the EU. By bringing all...
Biomapas Nordic AB Appoints Ola Jeppsson to CEO & Business Development Director
August 2021 Ola Jeppsson has taken on a leading role as Business Development Director. In addition to his new role, he was appointed as a Chief Executive Officer at Biomapas Nordic AB starting August 2021.Having a management and business development background in the life sciences industry, he...
7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy
Choosing the right set of countries, sites and investigators for a clinical trial are critical success factors in any clinical development program. They can guarantee speedy patient recruitment and timely delivery of study results. It also ensures that you conduct your clinical trial within budget...
Clinical Study Start-Up: Is there any Difference Between Western and Eastern Europe?
This article reviews Clinical Study Start-up Differences Between West & East Europe, timelines, and processes. Medicine is constantly evolving to invent effective ways to treat diseases. This progress is a never-ending process: the life science industry develops new molecules and treatments...
Running a Clinical Trial in Ukraine
Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.
What You Need to Know about Running a Clinical Trial in Russia?
Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).
Expediting access through Reliance Pathways: MENA region
Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.
Medical Device Registration in Russia. Challenges and Issues
Webinar: Medical Device Registration in Russia. Challenges and Issues The purpose of this webinar is to show the differences and specifics of regulations and law processes that can cause challenges in medical device registration in Russia. You will learn about: 1. The specificity of...
eCTD Submission Strategies: In-house vs. Outsourcing
Webinar: eCTD Submission Different Strategies: In-house vs. Outsourcing eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various regulatory strategies. Thus,...
Drugs serialization and barcoding in Saudi Arabia and MENA region
An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring pharmaceutical companies...
eCTD implementation across MENA region: What is the current status?
As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is the situation in the Middle...
Building Health Literacy: The Value of Good Writing
Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.
