Blogs
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Lowering The TMF Temperature Through Quality Reviews
7/23/2024
Clinical studies are fraught with risk, embedded in every TMF process. To avoid major findings during an inspection, knowing when and how to lower the TMF risk temperature is crucial.
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EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection
7/17/2024
The complexities of EU GMP Annex 1 inspections can be challenging. At an event hosted by NIBRT and Cencora PharmaLex, industry experts shared key insights and best practices for ensuring compliance.
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Preparing The PMS: A Commercial And Regulatory Imperative
7/17/2024
Learn how proactive engagement with the Product Management Service (PMS) can pave the way for enhanced decision-making, operational agility, and sustained competitiveness in the pharmaceutical industry.
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A Five-Step Game Plan For A TMF Close-Out
6/27/2024
Navigate the complexities of clinical trial closure with our five-step strategy, ensuring compliance and readiness for inspection. Plan, review, and archive effectively for a seamless TMF journey.
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Key Trends And Hot Topics From The Fierce TMF Summit US
6/21/2024
Gain insights into how experts are handling regulatory changes, AI integration, and resource constraints in Trial Master File (TMF) management through insights showcased at the recent Fierce TMF Summit.
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Building A Delegation Profile For The QPPV
6/17/2024
Learn how strategic delegation can optimize the role of the Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure efficient oversight and compliance in this insightful article.
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Vigilance Guidance Provides Greater Clarity On MDR Requirements
6/12/2024
Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.
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How Intuitive Decision Rules In Clinical Trials Can Support Regulatory Requirements
6/12/2024
See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.
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EMA's Concept Paper On Confirmatory Clinical Studies A Welcome Step For Industry
6/12/2024
Explore the implications of the European Medicines Agency's Concept Paper, its potential impact on biosimilar developers, and the broader implications for the pharmaceutical industry.
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Navigating Promotional Materials Requirements In Europe
6/12/2024
From navigating local laws to strategic planning, explore how companies can manage their promotional campaigns while adhering to strict regulatory guidelines.