Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic
Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...
FDA Works to Accelerate the Development of COVID-19 Treatments with New Guidance Documents
On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to...
Clinical Trials in the Midst of COVID-19, Part One: European Medicines Agency (EMA)
Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...
EMA Extends Due Date for Nitrosamines Impurities Risk Assessment Due to COVID-19
EMA has extended the deadline to assess the risk of nitrosamine impurities to 31 March 2021. This decision was made based on the reports of the challenges encountered in meeting the original deadline...
Meet the Expert: Dr. Borja López Pérez
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 support...
Establishing Process Equivalency
A common question when transferring an established process from one facility to another is how to establish that the transferred process is performing equivalently to the original process. Sounds...
How to Safely Launch Medical Cannabis Products in Germany
Over the past few weeks the withdrawal of cannabis products from the German market has been a topic which generated a lot of publicity. Therefore, we want to share some tips on how to safely launch...
Meet the Expert: Hannah Hunter
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 support...
Just How Mature Is Your Data Lifecycle / Data Management Function?
The attention of regulatory agencies continues to focus on data integrity, as observed by the increase of FDA observations over the course of the last few years. Having a proper data lifecycle / data...
Get the Most Out of Your GMP Effectiveness Checks
Get the Most Out of Your GMP Effectiveness Checks: We work in a highly regulated industry. Whether you are associated with the manufacturing of a drug, a biologic, or a device, you understand the...
Utilizing an Agile Framework When Implementing ATMPs
Who says you can’t teach an old dog a new trick? Having spent the last 25+ years in small molecule, large molecule, medical devices, I have spent a lot of time planning and executing everything from...
Meet the Expert: Mary Speckin
ProPharma Group has launched a "Meet the Expert" series to introduce 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 support...
Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...
Health Apps and the Requirements Imposed By the Law
If you check Apple’s App Store or Google’s Play Store you will find an overwhelming list of health and fitness apps. This list only gets longer, if you include the number of people who use these...
7 Things to Consider in Medicinal Cannabis Development
Mention the word cannabis and the confusion starts; legal or illegal, nutraceutical or medicinal product, psychoactive or non-psychoactive, clinically significant or not. At the same time, the...
Industry Poll: How Can Your GMP Auditing Program Be Most Improved
Recently, ProPharma conducted a poll to quality professionals across the country to understand the challenges that FDA regulated companies face in managing their GMP auditing programs. As depicted in...