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...
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...
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...
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...
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...
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...
The Trifecta of Promotional Review: What is a PRC & What do They Do?
The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...
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...
EU Pharmaceutical Legislation Reform: Where Are We Now?
On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
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...
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...
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...
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...
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...
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...