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.

Quality Management Systems Life Science Consulting

October 26, 2017

Transformational Leadership: Part II

Last week, I introduced a two-part series on transformation leadership. We defined transformational leadership, explored the concept, and discussed the benefits of adopting this approach. Well, now...

Quality Management Systems Life Science Consulting

October 18, 2017

Transformational Leadership: Part I

A couple of years ago, an organization asked me to present to their Leadership Team regarding transformational leadership. They wanted to have a better understanding of what makes an organization...

Quality Management Systems Life Science Consulting

February 7, 2017

Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process

Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process: The Parenteral Drug Association (PDA) recently published a revised version of Technical Report No....

Quality Management Systems Life Science Consulting

April 22, 2014

Quality System Professionals: Learn how to Speak “Executive-ese”

It is amazing to me that more C-Level Executives do not perceive their Quality Systems as a powerful vehicle to reduce costs, improve productivity, and benefit their bottom line. Rather than embrace...

Quality Management Systems Life Science Consulting

December 11, 2013

Critical Elements of Knowledge Management in a Pharmaceutical Quality System

The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...

Quality Management Systems Life Science Consulting

June 26, 2013

ISO13485: Understanding the Management Review Metrics Scorecard

As discussed in part one and part two of this series, ISO13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the...

Quality Management Systems Life Science Consulting

June 5, 2013

ISO13485: Do You Know What Types of Data Should Be Evaluated at Management Review Meetings?

ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS). Section 5...

QMS ISO 13485

May 13, 2013

ISO13485: The Importance of Management Review

ISO13485: The Importance of Management Review: ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of...

Quality Management Systems Life Science Consulting

December 18, 2012

Which Comes First, People or Systems? - Building & Maintaining Regulatory Compliance

 Regulations require the pharmaceutical industry to be compliant, have and maintain a quality system, and build quality into the process (quality by design). What does that truly mean and how does...

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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...

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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...

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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...

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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...

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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...

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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...

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Inspiring the Future of Drug Development

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