Medical Information
Navigating Medical Inquiries Across Europe: Why Multilingual Support Matters for MAHs
Europe is one region — but it is far from uniform. For Marketing Authorization Holders (MAHs), providing consistent, compliant Medical Information (MI) support across the continent requires...
Quality & Compliance
From Reactive to Proactive: The New MAH Compliance Standard
As global regulatory expectations evolve, one trend is unmistakably clear: Marketing Authorization Holders (MAHs) must take a more proactive role in monitoring and managing supplier compliance....
Medical Information
Mastering the Pharmacovigilance System Master File (PSMF): A Guide to Inspection Readiness
In the highly regulated pharmaceutical industry, maintaining a robust pharmacovigilance system is essential to ensure patient safety and regulatory compliance. One of the most critical documents...
Medical Information
A Smarter Front‑Desk Model: Multilingual Contact Center Support for MAHs
For Marketing Authorization Holders (MAHs), ensuring that healthcare professionals (HCPs) and patients can easily access the organization is essential to delivering safe, compliant, and high‑quality...
Regulatory Sciences
Marketing Authorization and Market Access: Navigating Pricing & Reimbursement Before and After Approval in Europe
For decades, pricing and reimbursement activities have been handled separately from the regulatory process and typically only began once regulatory approval was secured. This separation has largely...
Medical Information
Why Medical Information Is Central to MAH Compliance, Access, and Patient Safety – Identifying Reportable Information
Inquirers rarely contact Medical Information (MI) to report an adverse event (AE), special situation event (SSE), or product quality complaint(PQC). They call because they have a question, but...
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...
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...
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,...
Pharmacovigilance
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)
In today’s stringent regulatory landscape, the effectiveness of a pharmaceutical company’s pharmacovigilance (PV) system is supported by three key pillars: the Qualified Person for Pharmacovigilance...
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...
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...
Pharmacovigilance
Signal Detection and Management - The Pursuit of Safer Products
Signal detection for products in development Why signal detection in clinical development? Early safety signal detection enables: Early identification of safety risks Informed decision making Meets...
Pharmacovigilance
An Overview of the PSMF: Pharmacovigilance System Master File
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...