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Earlier this year I wrote to you about US FDA March 2020 issuance of a new guidance for industry, Investigators, and Institutional Review Boards regarding the conduct of clinical trials during the...
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Regulatory Sciences
It's the FDA, Not the NBA Aside from being a spectacular thing to watch, the slam dunk is the highest percentage shot a basketball player can take. The likelihood of getting the ball in the basket is...
Clinical Research Solutions
Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage. Examples of...
Regulatory Sciences
Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution. The European Medicines Agency (EMA) has issued draft guidance on how...
Quality & Compliance
The Annual Product Review (APR), also known as the Annual Product Quality Review (APQR), is required for marketed products in an FDA-regulated environment. You may ask, "Why would I want to perform...
Pharmacovigilance
As we approach the final months of 2020, the pharmaceutical world begins, once again, to focus its thoughts on the impact of Brexit, not least in the world of pharmacovigilance. Of course, the UK has...
Quality & Compliance
EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...
Clinical Research Solutions
In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the...
Clinical Research Solutions
Last week, FDA issued a final rule regarding the importation of certain prescription drugs from Canada. This action was taken by the agency as part of the Safe Important Action Plan, and was done in...
The interest in developing consumer products or therapies derived from Cannabis or CBD is continuously growing. As these new products come to market, there is increasing need to comply with...
Quality & Compliance
Reflecting on 2020, we have become accustomed to the global shift into a world of virtual, remote, restricted, and paused. One no longer flinches when hearing that something has been modified,...
Clinical Research Solutions
You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should...
Cell and Gene Therapy (CGT)/Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to the...
Drug development can be a protracted and multifaceted process. This is often the case for startups and newer organizations, which may not have dedicated regulatory compliance departments and...
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...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
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...
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...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...