Quality & 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
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
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
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
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
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 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
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
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
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...
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
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...
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...
Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...
Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...