Every successful clinical trial starts long before the first participant is enrolled. Site Selection and Activation is one of the most important, yet often overlooked, stages of clinical research. From identifying the r...
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Italy’s new serialisation framework: navigating the transition to a hybrid model
Italy’s revised serialisation framework represents a significant evolution in pharmaceutical traceability. The hybrid model introduces complexity but also aligns Italy more closely with European standards while preserving its strong national safeguards.
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Navigating the EU Packaging & Packaging Waste Regulation (PPWR): Implications for pharmaceutical labelling and beyond
The European Union’s Packaging & Packaging Waste Regulation (PPWR) represents one of the most significant regulatory shifts in decades for companies placing products on the EU market. With applicability from 12 August 2026, this regulation introduces far-reaching changes to packaging design, labelling and lifecycle management, with particular implications for the pharmaceutical sector.
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Real-time clinical trials: a pivotal shift and a global question
While the FDA’s direction is gaining attention, a more important question for sponsors is emerging: how will this approach translate in a global regulatory landscape, where development and approval must extend well beyond the US to achieve commercial success?
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Japan’s clinical trial transformation: Building a global future
Japan is modernising clinical trials to address drug lag and improve access to innovative therapies. In this blog, we explore some of the changes and why they are making Japan a more attractive choice for clinical trials.
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Streamlining the biosimilars playbook
In this blog, we explore two major March 2026 regulatory changes from the European Medical Agency (EMA) and U.S. Food and Drug Administration (FDA) and their potential ramifications.
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A framework for pediatric HRQoL selection: Evaluating the PedsQL™
This article outlines a practical framework for selecting a pediatric HRQoL instrument and applies that framework to the Pediatric Quality of Life Inventory™ (PedsQL™).
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Lessons learned in EU HTA Regulation’s first year
The EU’s Health Technology Assessment Regulation (HTAR) officially launched in January 2025, ushering in a new era of streamlined, harmonised Joint Clinical Assessments and Scientific Consultations across Europe. This article reflects on key learnings from the first year which focused on oncology and ATMPs and explores what to expect as the system expands in 2026 and beyond.
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Mechanism of action in pediatric research
Discover how EMA’s proposed MoA-based PIP requirements mirror the US RACE for Children Act and how sponsors can prepare for pediatric regulatory changes.
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Managing risk for medical devices part 4
This blog looks into the logical basis for the use of comparisons in biological risk estimation. The same basic principle has been used for over 50 years. A comparative approach, presented as guidance in ISO 10993-18:2005, has now been transformed into a key element of ISO 10993-1:2025.
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Managing risk for medical devices part 3
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation.
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Managing risk for medical devices part 2
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation. In this edition we discuss ISO 14971: What it is and is not.
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Understanding FDA regulations for AI in SaMD
Despite an increase in AI-enabled medical devices receiving FDA approval there is no distinct regulatory route. Learn about FDA guidance on AI in SaMD.
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Strategies for successful Integrated Summary of Efficacy and Safety (ISS/ISE) submissions
Developing an integrated summary of safety and efficacy (ISS/ISE) can be complex. This blog outlines practical strategies to organise data, plan efficiently and ensure compliant, high-quality submissions.
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Customer advocacy: A strategic imperative for regulatory consultancy excellence
Customer advocacy is key to regulatory consultancy success. In life sciences, trust, transparency, and client-focused partnerships are essential for navigating complexity and driving performance.
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Managing risk for medical devices part 1
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation. In this edition we discuss which risk management principles are right for medical devices?
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CMC in Drug Development and Life Cycle Management
This blog provides emerging and biotech companies with a significant overview of the considerations for CMC. There are a multitude of complexities and points to consider when creating an asset and product development is at the centre
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Measuring the impact of ICH E9(R1) on UK research protocols
The ICH E9(R1) Addendum, adopted in November 2019, aims to clarify treatment effects in clinical trials. Tim Clark, ICON’s VP of Clinical Sciences, co-authored a study reviewing how UK research protocols apply estimands and how usage has evolved since the addendum’s adoption.
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Rising to the challenge with innovative therapies
Global regulators are streamlining access to innovative therapies—but navigating these pathways takes strategy. From FDA’s Breakthrough to EMA’s PRIME, early planning and expert partnerships make the difference.
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How Project Optimus has impacted oncology-focussed biotech companies
By focussing on dose-optimisation the FDA’s Project Optimus is changing how oncology-focussed biotechs develop their treatments.
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To avoid HTAR bottlenecks NICE and MHRA offer a strategic alternative
This blog explores how drug and medical device developers can engage with the MHRA and NICE as a strategic alternative when access to Joint Scientific Consultations (JSCs) is limited.
