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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!

Pharmacovigilance & Medical Information
Clinical Research
Regulatory Affairs
Videos
Building Health Literacy: The Value of Good Writing

Building Health Literacy: The Value of Good Writing

Oct 21, 2020

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

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Oct 2, 2020

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 do you need to know while preparing RMP for EAEU and CIS region?

What do you need to know while preparing RMP for EAEU and CIS region?

Aug 4, 2020

Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.

MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

Apr 21, 2020

Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.

Biomapas appoints Head of Global Pharmacovigilance

Biomapas appoints Head of Global Pharmacovigilance

Mar 13, 2020

March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.

What is a Safety Signal?

What is a Safety Signal?

Jan 6, 2020

Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.

7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy

7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy

May 24, 2021

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...

Running a Clinical Trial in Ukraine

Running a Clinical Trial in Ukraine

Mar 24, 2020

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?

What You Need to Know about Running a Clinical Trial in Russia?

Aug 1, 2019

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).

The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?

The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?

Jun 27, 2019

The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions.

eCTD implementation across MENA region: What is the current status?

eCTD implementation across MENA region: What is the current status?

Mar 11, 2021

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

Building Health Literacy: The Value of Good Writing

Oct 21, 2020

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.

CMC: Down the road in effective IND/IMPD writing

CMC: Down the road in effective IND/IMPD writing

Oct 8, 2020

In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing particulars giving some key messages on document preparation. Now, we will discuss other important points. These are safety, data completeness, and geographical regions.

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Oct 2, 2020

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.

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

Aug 12, 2020

It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments for such transitions. The value for M&A in the pharmaceutical sector was $221 billion in the first half of the year 2015. In 2019, the worth of pharma companies M&A activities have reached $357 billion.

CMC: Best Practice in Effective IND and IMPD writing

CMC: Best Practice in Effective IND and IMPD writing

Aug 6, 2020

This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.

Episode 1 Biomapas Insights

Key insights from Raul Flores Medina, Local Safety Officer for LATAM, about the evolving Pharmacovigilance landscape across the LATAM region.

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Episode 2 Biomapas Insights

Mina Awad, a GxP Auditor, Inspector, and PV expert with over 17 years in the pharmaceutical industry shares timely updates on the evolving Pharmacovigilance landscape in the MENA region.

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Episode 3 Biomapas Insights

Theo Giannou and Wee Chuan Lau from Bloom Agents, a regional pharmacovigilance service provider with over 30 years’ experience across Asia-Pacific (APAC) discuss the PV scene in the region.

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The Perfect Partnership: How Mid-Sized CROs and Site Networks Deliver Clinical Trial Success

Balancing agility and reach, while ensuring operational efficiency and patient-centricity, is no straightforward task in clinical trials. One key enabler in achieving this balance? Finding the right partners – CROs and sites. Hear from a panel of experts across CRO and global and emerging site networks for real-world insights on the benefits of mid-sized CRO-site partnerships.

Diversity in Clinical Trials: A European Perspective on Global Progress & Strategies

Why does inclusive clinical research matter? Patients’ responses to treatments vary by many factors from gender and race to socio-economic status. As the industry becomes increasingly open for discussion, the need to explore this topic from a European perspective also arises.

Breaking silos across Medical Information & Pharmacovigilance

Discover solutions for effective PV & MI data management, including handling Adverse Events, Product Quality Complaints, and MI inquiries. Our experts will walk you through real-life examples and hands-on solutions.

Unlocking Success: The FSP Advantage in Clinical Research

FSP is a rising trend in clinical research, expected to gain further prominence due to its cost-effectiveness and demand for specialised expertise. Our FSP model offers benefits such as cost savings, expert advice, flexibility, and risk mitigation.

Regulatory Outsourcing in the CEE Region

Watch this informative session that promises to decode the intricate landscape of regulatory affairs outsourcing in the CEE region and provide practical, implementable strategies to optimize and maximize your operations and outsourcing strategies.

Benefits of Integrating Pharmacovigilance & Medical Information

Are you interested in learning about the benefits of integrating Pharmacovigilance and Medical Information? In this webinar, we discuss the advantages of combining these two critical components of drug safety. We discuss how you can achieve this integration by sharing our real-world experience.

Shortly? We aim to help you successfully integrate these functions and realize their positive impact on your operations and patient outcomes.

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 studies. Many trials have been shifted to other countries or regions while the complexity of managing risk increases.

Even though managing your studies in these economic times might seem challenging, all you need is thoughtful preparation and adaptation measures. Our experts will share practical tips and experience-based results on how you can do it too.

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 product.

Our experts lay out all the steps necessary to set up a system and discuss best practices in critical areas. Additonally, we dive into actual best practices to overcome day-to-day challenges.

Regulatory Framework of Drugs in MENA: Insights

In this webinar, our experts discuss regulatory affairs of medicinal products. Two aspects that have recently gained increasing importance among the various stakeholders, namely the eCTD implementation across the region and the serialization and barcoding requirements for medicinal products.

So, we share our insights on these two aspects and share how you can avoid various issues in drug registration.

How to avoid delays in your early phase oncology trial?

The number of oncology clinical trials increases year after year as more treatment options seek to reach the market. However, these studies and becoming progressively more complex, bringing new challenges.

Many things can go array in your early phase oncology studies, costing precious time and increasing overall costs. So often, a simple question arises: how to avoid these delays in early phase oncology studies?

Pharmacovigilance Opportunities in the MENA region

Together the 22 MENA countries have a 350 million population that spends over $30 billion on pharmaceutical products per year and show robust growth. However, it is not a simple task to enter this market due to various factors, including the lack of a centralized pharmaceutical regulator.

How do you effectively guarantee pharmacovigilance in a region that shows significant differences in pharmacovigilance maturity at the country level?

Q&A 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 just in this Eastern European nation but throughout the world. There might be delays throughout development, loss of business continuity, and risk of non-compliance for on-market products.

Our experts dive into the question ‘How does the conflict between UA & RU impact the pharma industry?’.

Regulatory Strategy in EAEU and rest of CIS Countries

Navigating market access in the Commonwealth of Independent States (CIS), both within the Eurasian Economic Union (EAEU) and beyond, necessitates understanding their unique challenges and opportunities. Central to this is the adherence to Good Manufacturing Practice (GMP) requirements across these regions.

Our webinar provides practical insights into regulatory strategies for successful market entry in the CIS, focusing on current scenarios and high manufacturing standards.

eCTD Submission Different Strategies: In-house vs. Outsourcing

Understanding the complexities of eCTD (electronic Common Technical Document) submissions is vital for choosing the optimal approach: in-house or outsourcing. Both options have distinct merits, with outsourcing offering expert resources and cost-effectiveness, while in-house control ensures direct oversight.

Our webinar discusses these strategies, the need for technical resources, and the importance of validating submissions for compliance, providing practical tips for quality submissions regardless of the chosen strategy.

Effective IMPD Writing: The Quality Part

IMPD is a 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 authorities in EU.

The purpose of this webinar is to share the best practices in the preparation of IMPD in order to meet the expectations of competent authorities and to learn why effective CMC technical writing is critical for the development of a high quality IMPD.

Successful Medical Device Registration in Russia: The Essentials

The current national system of 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 documented, some regulatory requirements are ambiguous and unwritten rules play an essential role during the process.

The purpose of this webinar is to explain the process and share the experience in the field of Medical Device registration in Russia.

Affiliate Based Outsourcing Model for Regulatory Affairs: An Introduction

 Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as sometimes their processes are not harmonized across different countries, the resources are not cost-optimized or simply there isn’t enough of them.

The purpose of this webinar is to share practical tips and insights on the effective optimization of local RA setup, management and relevant costs.

Medical Device Registration in Russia: Challenges and Issues

This webinar navigates the complex terrain of Medical Device registration in Russia. We will explore unique national classifications that differentiate between medical devices in the EU and Russia, discuss challenges in registering complex and multi-component devices, and understand the Russian approach to Software as a Medical Device (SaMD).

This session is designed to demystify Russian regulations, providing insights to conquer challenges in medical device registration.

Strategic Pharmacovigilance Activities: Scalable and Tailor-made Outsourcing Models

Larger companies often limit their pharmacovigilance outsourcing only to highly manual and repetitive tasks, while the smaller ones may want to outsource their entire pharmacovigilance system. But is there anything in between?

This webinar shares insights on strategic PV outsourcing that can be personalized for any needs or requirements:

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.
Affiliate-Based Outsourcing
CSV For Pharmacovigilance Systems
Early Phase Oncology
Functional Service Provision
M&A Support

Clinical Research

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