Biomapas Logo

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!

Literature Monitoring in Pharmacovigilance

Literature Monitoring in Pharmacovigilance

Incorporating data from medical and scientific literature is a paramount aspect of patient safety. This wealth of knowledge often constitutes a substantial part of the safety profile of medicinal products. From providing insights on potential side effects to shedding light on different patient...

Pharmacovigilance in Early Phase Clinical Trials

Pharmacovigilance in Early Phase Clinical Trials

Welcome to the fascinating yet complex world of Pharmacovigilance (PV)! This field stands as an indispensable pillar in drug safety, ensuring the well-being of millions around the globe. However, the path is far from smooth; it's full of unique challenges and critical responsibilities, especially...

Outsourcing in Pharmacovigilance

Outsourcing in Pharmacovigilance

Imagine a pharmaceutical company navigating the intricate labyrinth of drug development and patient safety. Amid these complexities, an intriguing solution has been emerging: pharmacovigilance outsourcing. This practice involves entrusting a part or the entirety of pharmacovigilance functions to...

Let’s celebrate success

Let’s celebrate success

Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new countries all around the globe and the...

Adaptive Clinical Trials

Adaptive Clinical Trials

What are Adaptive Clinical Trials? And how can we leverage their distinguished ability to evolve to improve clinical designs?

Setting Up a Phase 1 Oncology Study

Setting Up a Phase 1 Oncology Study

Explore setting up a Phase 1 Oncology Study successsfully! Learn about critical preparation, meticulous planning, and effective execution.

Download – ABO Whitepaper

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 the Clinical Trials Regulation?

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...

Different Affiliate Based Outsourcing Models for Regulatory Affairs

Different Affiliate Based Outsourcing Models for Regulatory Affairs

Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs Often questions arise about the Affiliate-Based Outsourcing (ABO) Models for Regulatory Affairs:1. How can it fit your specific needs?2. How can it adapt to your organization and setup?3. What are its possibilities of...

Marketing Authorization Process in Russia

Marketing Authorization Process in Russia

Cultural and language problems are a frequent stumbling block for multinational corporations seeking to register drugs in Russia. Additionally, the Marketing Authorization process in Russia is highly complex, and the paperwork frequently changes as the regulatory framework evolves. However, the...

Drug Registration in Russia

Drug Registration in Russia

 Overview of drug registration in Russia The Russian pharmaceutical industry is expected to exceed two trillion Russian rubles in 2020, representing a roughly 10% growth over the previous year. Pharmaceutical revenues are expected to reach 2.35 trillion Russian rubles by 2023. It's also worth...

In this episode of Biomapas Insights, Albert Bekfi, Head of Global Pharmacovigilance Operations at Biomapas, speaks with Mina Awad, a GxP Auditor, Inspector, and PV expert with over 17 years in the pharmaceutical industry. Based in the UAE and originally from Egypt, Mina shares timely insights on the evolving Pharmacovigilance landscape in the MENA region.

In the first episode of our new video series, Biomapas Insights, Albert Bekfi, Head of Global PV Operations at Biomapas, is in conversation with Raul Flores Medina, Local Safety Officer for LATAM, about the evolving Pharmacovigilance landscape across the LATAM region.

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.

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.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information