Insights & Resources For Life Sciences Professionals.

Biomapas Insights: MENA PV Landscape – Key Updates & Inspection Trends

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.

Biomapas Insights: Navigating Pharmacovigilance Requirements in LATAM

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.

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

eCTD Submission Different Strategies: In-house vs. Outsourcing

Effective IMPD Writing: The Quality Part

Successful Medical Device Registration in Russia: The Essentials

Affiliate Based Outsourcing Model for Regulatory Affairs: An Introduction

Medical Device Registration in Russia: Challenges and Issues

Strategic Pharmacovigilance Activities: Scalable and Tailor-made Outsourcing Models