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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.

Meet the Expert: David Lough

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 highlight how our colleagues work together on our higher purpose to improve patient health and safety...

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Quality & Compliance

How to Decentralize Cell and Gene Therapy Treatments

The Challenge: CAGT Treatments Require Time and Lack Availability Persons diagnosed with life threatening diseases which are now treatable with cell and gene therapies (CAGT) often needed to wait for...

Meet the Expert: Kirsty Bryant

Medical Information

Meet the Expert: Kirsty Bryant

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...

Regulatory Sciences

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...

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Quality & Compliance

Maximizing Cost Efficiency: The Financial Advantages of Outsourcing Vendor Audits

In today's dynamic business landscape, organizations in the drug, biologics, and medical device industries face the dual challenge of delivering quality products while managing tighter budgets and...

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Quality & Compliance

FDA Publishes Guidance for CAR T Products

In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor...

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Regulatory Sciences

Mandatory HTAR Implementation in the EU: Part 2

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking...

Ensure Compliance with EU HTA Regulation (HTAR) Guidelines & Implementation

Regulatory Sciences

Mandatory EU HTAR Implementation: Part 1

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health...

Quality & Compliance

The Importance of EU/UK QP Audits

In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. One crucial aspect of this assurance lies in the oversight provided by...

Regulatory Sciences

Beyond the Trifecta: Best Practices for a Successful Promotional Review Committee (PRC) Process

To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By...

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Clinical Research Solutions

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...

Clinical Research Solutions

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...

Clinical Research Solutions

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...

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Medical Information

What are Patient Support Programs?

Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...

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Clinical Research Solutions

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...

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Regulatory Sciences

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...

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