Pharmacovigilance
Single Safety Database
July 28, 2023
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...
Meet the Expert
Pharmacovigilance
June 29, 2023
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...
EU
MAH
September 3, 2021
The Essential Guide to Local Person for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. When setting up a pharmacovigilance system in Europe, the Qualified Person for...
Meet the Expert
Pharmacovigilance
January 27, 2021
Meet the Expert: Tim Kolbrink
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
ICSR
RMP
January 7, 2021
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence is the act of gathering and analyzing publicly available regulatory information, communicating...
Meet the Expert
Pharmacovigilance
November 24, 2020
Meet the Expert: Victor Mattisson
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Pharmacovigilance
October 13, 2020
Is Your Pharmacovigilance Team Ready for Brexit?
As we approach the final months of 2020, the pharmaceutical world begins, once again, to focus its thoughts on the impact of Brexit, not least in the world of pharmacovigilance. Of course, the UK has...
Pharmacovigilance
August 12, 2020
EMA Vaccine Applications for COVID-19 Explained
Preventive vaccines are a special kind of medicinal product, as they are administered before a disease instead of during. You are probably familiar with preventive vaccines from your own or your...
Pharmacovigilance
Regulatory Sciences
May 15, 2020
FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...