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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.

Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights

As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a robust and compliant MI function is crucial to the success of the product lifecycle and demonstrates...

Clinical Research Solutions

How to Leverage EMA’s ATMP Classification

Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare diseases and other conditions with unmet clinical needs. As of 2022, sixteen ATMPs have been approved by...

Clinical Research Solutions

The 5 Phases of Project Management + Pro Tips for Success

Guilty as charged! I used to think a project manager’s (PM) sole job was to remind everyone about deadlines and set up status meetings. I learned firsthand while working at a medical device start-up,...

Clinical Research Solutions

Meet the Expert: Jennifer Daudelin

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...

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Clinical Research Solutions

Project Management isn’t brain surgery, but why is it so hard?

Here is the scenario: you are the leader of a group and you have been given the responsibility of driving the completion of a new initiative, an early or late-stage drug or devices program, or a...

Clinical Research Solutions

Maximising on Scientific Advice Procedures in Europe

A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...

Computer generated image of COVID-19

Clinical Research Solutions

EMA adopts first list of critical medicines for COVID-19

News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...

Clinical Research Solutions

Meet the Expert: Elina Koli

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...

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Clinical Research Solutions

What is Product Lifecycle Management and Why is it Critical for Success?

Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization....

Clinical Research Solutions

Understanding ICH M10 “Bioanalytical Method Validation and Study Sample Analysis”

The final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was adopted on May 24, 2022. This is the harmonized guideline which has been ratified by participating...

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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...

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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Medical Information

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...

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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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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