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...
Pharmacovigilance
The LPPV Network: An Essential Guide to Local Person Responsible for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. Within the EU a pharmacovigilance system is defined as a system used by an...
Pharmacovigilance
The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...
Clinical Research Solutions
Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
Clinical Research Solutions
5 Benefits of Receiving EU PRIME Designation for Medicine Developers
What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...