Regulatory Sciences
The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 2
Change in the Submission of the Summary Notification Information Format The Summary Notification Information Format Form As of January 31, 2023, Sponsors are required to submit a Clinical Trial...
Regulatory Sciences
The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 1
The Benefit of the Common Application Form for GMO Applications GMO Application Not Included in Clinical Trial Regulation With the transition period for the Clinical Trial Regulation No 536/2014...
Regulatory Sciences
Highlights from FDA's Analytical Test Method Validation Guidance
Recently, the FDA updated a long-standing, decades old guidance on analytical test method validation based on revisions of the ICH Q2(R2) guidelines. Traditional test method validation requirements...
Regulatory Sciences
MLR Submission Content: Setting Yourself up for a Successful PRC Review
Having a highly efficient well-oiled Promotional Review Committee (PRC) machine is not just about having rock star reviewers and effective best practices in place. Although those are both critical...
Regulatory Sciences
How to Successfully Prepare for the HTAR Implementation in the EU
Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for 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...
Regulatory Sciences
Mandatory HTAR Implementation in the EU: Part 2
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...
Regulatory Sciences
Mandatory EU HTAR Implementation: Part 1
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...
Regulatory Sciences
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...
Regulatory Sciences
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...