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.

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal, providing healthcare professionals, patients, and caregivers with accurate, non-promotional product...

Unlocking Success with Clinical Trial Safety Monitoring During a Pandemic

Earlier this year I wrote to you about US FDA March 2020 issuance of a new guidance for industry, Investigators, and Institutional Review Boards regarding the conduct of clinical trials during the...

Meet the Expert: Matthew Weinberg

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...

Why Drug Approvals Are Never Slam Dunks

It's the FDA, Not the NBA Aside from being a spectacular thing to watch, the slam dunk is the highest percentage shot a basketball player can take. The likelihood of getting the ball in the basket is...

Clinical Research Solutions

The Evolution of Medical Writing

Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage. Examples of...

Clinical Research Solutions

Filing Using Registry-Based Studies? EMA Issues Draft Guidance

Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution. The European Medicines Agency (EMA) has issued draft guidance on how...

Uncover Opportunities for Improvement with an Annual Product Review

The Annual Product Review (APR), also known as the Annual Product Quality Review (APQR), is required for marketed products in an FDA-regulated environment. You may ask, “Why would I want to perform...

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...

EudraLex Volume 4, Annex 1 Update: What You Need to Know

EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...

5 Ways the Medical Industry is Using Data Science

In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the...

Clinical Research Solutions

10 Things You Need to Know about FDA’s Final Rule on Importing Prescription Drugs from Canada

Last week, FDA issued a final rule regarding the importation of certain prescription drugs from Canada. This action was taken by the agency as part of the Safe Important Action Plan, and was done in...

How to Prepare for Laboratory Partner Selection during CBD Product Development

The interest in developing consumer products or therapies derived from Cannabis or CBD is continuously growing. As these new products come to market, there is increasing need to comply with...

Average number of observations per Audit

Quality & Compliance

How Many Observations are Hiding in Your Quality System?

Reflecting on 2020, we have become accustomed to the global shift into a world of virtual, remote, restricted, and paused. One no longer flinches when hearing that something has been modified,...

Clinical Research Solutions

6 Tips to Prepare Your Medical Cannabis Facility for Inspection

You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should...

3 Basic Data Integrity Principles to Protect Value and Drive Success for Cell and Gene Therapy/ATMP Development

Cell and Gene Therapy (CGT)/Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to the...

Regulatory Strategy in Pharma & Biotech Submissions Trial Design

Drug development can be a protracted and multifaceted process. This is often the case for startups and newer organizations, which may not have dedicated regulatory compliance departments and...

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

Hands working on a laptop.

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...

Healthcare worker showing a woman details on a tablet device.

What are Patient Support Programs?

Patient Support Programs (PSPs)  in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

Several business professionals talking around glass conference table

Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

Low angle of the United States Capitol Building

The Impact of a US Government Shutdown on the Food and Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

Casually dressed business professionals discussing intensely at a conference table

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...