Regulatory Sciences
First Joint Clinical Assessments (JCAs): Key Lessons for EU HTA
The First JCAs Are Revealing More Than a New Process: Early Lessons and JCA Readiness As the first Joint Clinical Assessments (JCAs) moved from planning into practice, a clearer picture is emerging...
Turning Regulatory Complexity into Predictable Study Start-Up Execution
Regulatory complexity is unavoidable in global clinical development. The differentiator is not whether organizations face complexity, it is how effectively they operationalize it. Across Europe,...
Regulatory Readiness as a Strategic Advantage in European Study Start-Up
For years, regulatory readiness was often viewed primarily as a compliance function, an operational necessity required to move clinical studies forward. Today, that perspective is no longer...
Regulatory Sciences
Reclaiming the European Market: How to Secure EU/UK MAH Status Without the Local Infrastructure
For many US and APAC pharmaceutical companies, reacquiring the European rights to a successful, out-licensed product is a smart strategic move — an opportunity to capture greater margins, regain...
Medical Information
Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence
Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal,...
Regulatory Sciences
Transparency Requirements and the Requirement for Document Redaction
In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...
Regulatory Sciences
MAH Expertise Across Eastern Europe — and Beyond
Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...
Regulatory Sciences
Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS
Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...
Regulatory Sciences
The Moving Regulatory Landscape for Gene Therapy Trials in EU
Submitting a GMO Application for a Clinical Trial with AAV Viral Vectors Navigating the regulatory landscape for clinical trials in the European Union (EU) has become more streamlined with the...
Quality & Compliance
European Marketing Authorization Success: The Critical Role of Quality and Compliance
Entering the European market isn't just about gaining marketing authorization — it's about sustaining it. For life sciences companies, success hinges on a robust approach to quality and compliance,...
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...
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...
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...
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...