Medical Information
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Pharmacovigilance is a global responsibility, and regulatory requirements may differ significantly depending on the region. One such region-specific requirement is the Periodic Adverse Drug...
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...
Regulatory Sciences
Navigating the German Pharmaceutical Landscape: Part Two
Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...
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...
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...
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
Vigilance by Another Name
Do regulations and guidance documents sometimes stagnate your learning progress because of the terminology used? Regulation confusion is a common complaint heard from current and prospective new...