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...
ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades. Lord O’Shaughnessy Clinical Trial...
MoCRA 2022: Updated Requirements for Cosmetic Companies
MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of effectiveness the Modernization of Cosmetics Regulation Act of 2022 or "MoCRA" was...
Challenges in Clinical Development of Products for Rare Disease
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...
Rare/Orphan Diseases and the African American Community
How do we improve outcomes for an uncommon healthcare challenge in a community challenged with common healthcare issues? The Orphan Drug Act defines a rare disease as a disease or condition that...
After panning over the Boston Business Journal and seeing yet another local VC (Venture Capital) firm raise a record $350 million in venture capital for Massachusetts life science, I asked myself:...
Changes to the Animal Welfare Act Affecting Animal Research Facilities
Does your organization conduct or outsource testing to an Animal Research Facility? If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...
Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?
Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...
According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...
ProPharma Group's Dr David Crome to Act as Compliance Monitor to the MHRA
From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...
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...