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Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track

Regulatory Sciences

FDA Animal Rule: Overview & Impact on Drug Development

What is the Animal Rule? The Animal Rule, a regulation set by the US Food and Drug Administration (FDA), applies to the development and testing of drugs and biological products intended to reduce or...

Healthcare workers sharing a tablet device data with a coworker

R&D Technology

ELN Software Selection: Finding the Right Solution for Your Business

Electronic lab notebooks (ELNs) are now well established in the pharma/life sciences industry but with such a wide variety of options to choose from, how do you find the right solution for your...

Meet the Expert: Terri Levine

Clinical Research Solutions

Meet the Expert: Terri Levine

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...

Hands typing on laptop displaying diagram of DNA double helix

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...

Two lab techs working with petri dishes test tubs in clean room

Quality & Compliance

5 Key Challenges in the Development of Gene Therapies

Over three decades of gene therapy (GT) clinical trials have yielded many innovative and promising treatments for pernicious genetic disorders but industry has shown slow development and dashed...

Meet the Expert: Susanna Heinonen

Pharmacovigilance

Meet the Expert: Susanna Heinonen

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...

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...

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