thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

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...

Pharmacovigilance

May 8, 2020

Clinical Trials in the Midst of COVID-19, Part One: European Medicines Agency (EMA)

Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...

Medical Information Pharmacovigilance

April 14, 2020

Rapid and Responsive Implementation the Right Way: Learn How Preparedness and Adaptability can Protect your Medical Information Delivery during COVID-19

During the COVID-19 global pandemic, Medical Information (MI) and Pharmacovigilance (PV) teams are providing an extremely valuable service to deliver current and accurate product information to...

Statistical Intervals Confidence Interval Process Validation Life Science Consulting featured-image

Aug 15, 2013 12:00:00 AM

Understanding Statistical Intervals: Part 2 - Prediction Intervals

Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...

Read More
General Regulatory Drug Approval Regulatory Sciences featured-image

Mar 29, 2022 12:00:00 AM

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Read More
Biostatistics Clinical Research Solutions featured-image

Dec 22, 2020 12:00:00 AM

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...

Read More
ICH MW QC CSR Clinical Research Solutions featured-image

Dec 8, 2020 12:00:00 AM

A Guide to the Clinical Study Report

What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...

Read More
General Regulatory FDA Meetings Regulatory Sciences featured-image

Feb 28, 2017 12:00:00 AM

Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products

On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to...

Read More
Regulatory Sciences featured-image

Oct 12, 2022 12:00:00 AM

Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...

Read More
Prev 1 2 Next

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.