europe

Medical Information

Navigating EMA and Global Regulations for Medical Information Services

Medical Information services are essential to ensure healthcare professionals (HCPs), patients, and regulatory bodies receive accurate, timely, and compliant information. From managing inquiries to...

Regulatory Sciences

Mastering Clinical Trial Submissions in Europe: A Guide for Drug Developers

Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes. Recent regulatory...

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Regulatory Sciences

Advancing Digital Transformation in Medicines: EMA's Successful ePI Pilot

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant...

Regulatory Sciences

Expanding into Europe? Accelerate Your European Marketing Authorization

For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the...

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Pharmacovigilance

Understanding the Role of the Local Person for Pharmacovigilance (LPPV) in the Netherlands

For Marketing Authorisation Holders (MAHs) planning to market medicinal products in the Netherlands, compliance with local pharmacovigilance (PV) regulations is essential. At ProPharma, we understand...

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Pharmacovigilance

The Role of the LPPV in Switzerland and Liechtenstein: Navigating Local PV Responsibilities in DACHL (Part 2)

As we continue exploring pharmacovigilance (PV) requirements in the DACHL region, this second part of the blog series covers the local roles and obligations in Switzerland and Liechtenstein. While...

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Regulatory Sciences

Success in the European Pharmaceutical Market: Part Two

In part one, we covered the regulatory framework, compliance, and Wholesale Distribution Authorization. In part two, we’ll explore how success in Europe goes beyond regulatory approval—it’s also...

Professionals working around a tablet

Pharmacovigilance

The Role of the Local Person Responsible for Pharmacovigilance (LPPV) in the DACHL Region

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). For companies planning to market their...

Colleagues collaborating around a laptop

Regulatory Sciences

Success in the European Pharmaceutical Market: Part One

According to the European Federation of Pharmaceutical Industries and Associations, Europe is the second-largest pharmaceutical market in the world. Therefore, it is not surprising that many biotech...

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Regulatory Sciences

Navigating the New EU Health Technology Assessment Regulation (HTAR): Are You Ready?

The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...

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