Pharmacovigilance
The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)
Introduction According to §63a of the German Medicinal Products Act (AMG), a pharmaceutical entrepreneur who places finished medicinal products on the market that are medicinal products within the...
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
Meet the Expert: Thomas Chatzopoulos
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
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...
Pharmacovigilance
Understanding the PSUR and PBRER
Periodic Safety Update Reports (PSURs) play a pivotal role in ensuring the ongoing safety and efficacy of medicinal products once they've entered the market. While initial clinical trials provide...
Pharmacovigilance
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...
Pharmacovigilance
How to Spring Clean Your PV Safety Data for Optimal Performance
As the blossoms of spring usher in a season of renewal, it's not just our homes that could use a thorough cleaning – our safety data deserves a refreshing sweep too. In an enlightening conversation...
Clinical Research Solutions
Meet the Expert: Brian Wellins
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
Building Comprehensive PV Programs Around a Single Safety Database
What are the keys to building a comprehensive pharmacovigilance (PV) program? Be forward thinking, invest wisely, and question everything. It is so easy as a sponsor of a first-in-human clinical...
Clinical Research Solutions
Meet the Expert: Ioana Panturoiu
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...