Career progression is rarely linear, and there is no single path to leadership. In our latest blog, Sinéad McKeon discusses what drove her move from the lab bench to project management. She reflects on the capabilities...
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Filter blogs by either clicking within the ‘Category’ drop-down list, or begin typing which will automatically match to the nearest available category. Note - not all categories will display results if selecting a particular year.
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Adaptive trials and the new draft FDA guidance on data monitoring committees
The FDA’s recently released 2024 draft guidance on DMCs is the first update since 2006, marking an important renewal of emphasis on DMCs for modern clinical trials. Here we explore how some of these planned changes to the guidance will affect DMCs in relation to adaptive trials, including management, statistical analysis and delivery.
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Clinical trial protocol design amid evolving global IVD regulations
Clinical trial protocol design considerations driven by the current global evolution in vitro diagnostic device regulations impacting clinical testing laboratories.
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Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 2
In the previous blog of this series, we introduced the pilot PDP initiated by Health Canada including the types of PDP that can be submitted and the content and format of a C-PDP. This blog discusses the review of PDPs by Health Canada, amending agreed-to PDPs and annual reporting requirements.
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Making sense of the regulatory web governing biosimilars development across APAC
In recent years the Asia-Pacific (APAC) region has represented an area of growth in the biopharmaceutical sector, with expanding drug production and development — including in the area of biosimilars.
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Reassessing the UK's regulatory landscape post-Brexit
Brexit has had significant impact and presented many challenges for the health sector and the regulatory environment. Despite initial setbacks, the situation has been improving. In the first of our series of articles, we outline the challenges, how the Dept. of Health and the MHRA have embraced opportunities and how recent developments such as the Windsor Framework are providing clarity and stability.
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Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 1
Health Canada's pilot program for Pediatric Drug Development represents a significant step forward in ensuring the safety and efficacy of medications for pediatric populations. In the first of our 2-part blog series we provide the background, requirements and format needed to submit pediatric plans and studies.
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ICH GCP E6 (R3): transformative updates make good clinical practice better
The ICH GCP E6 (R3) updates represent a massive overhaul from the previous version. Learn topline impacts and next steps.
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Why translating core dossiers for marketing applications requires more than language skills
In this blog we outline why adoption of eCTD dossiers has increased and why translation requires regulatory expertise as well as language skills.
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Submission strategies for combined studies in the EU
In this article we look at how an oncology study sponsor managed their submission process which spanned more than 30 countries, many in the EU.
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Accelerating ATMP and CGT: The importance of regulatory CMC expertise in efficient biologics development
Discover how dedicated Regulatory CMC expertise benefits biologics development, ensuring compliance and efficiency, especially for innovative therapies like ATMPs and CGTs.
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Digital health: why evaluating human factors is essential
With the rapidly evolving technology, digital health is transforming healthcare, emerging as a promising solution to reduce rising healthcare costs and improve patient care.
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Digital health: managing cybersecurity risks
When developing a new digital health device, as well as maintaining an existing device, securing the device from cybersecurity attacks is critical.
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Utilising connected sensors to power diverse and equitable clinical trials
Our publication in Nature npj Digital Medicine outlines current evidence and a solution framework for diversity in research using digital health technologies.
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Enabling a new way to select fit-for-purpose COAs to simplify clinical protocols
While digital health technologies are one piece of the clinical protocol puzzle, holistic protocol design requires more breadth.
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Tested, tried and true: Why digital biomarkers are the AI & ML strategy pharma should prioritise
Rather than chasing generative AI, pharma executives can focus their AI and machine learning (ML) strategies for drug development on investing in and deploying connected sensors to reduce costs and improve patient outcomes.
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Outcome measures: Driving precision health strategies forward
ICON has been speaking, collaborating, and building with top pharma throughout the year to help them develop better drugs, faster, for patients. Here are a few observations from this year.
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Streamlining early phase clinical trial submissions under the EU CTR
The EU Clinical Trials Regulation (CTR) represented a significant shift in the regulatory landscape, aiming to create a more favourable environment for clinical research across Europe.
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Defining the differences when regulating medical devices, medicinal and combination products
A basic guide to the complex regulations governing clinical trials which involve medical devices and medicinal products.
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Essential components of a successful global labelling process
By incorporating these essential components, global labelling processes increase their fundamental impact on delivering an efficient drug development program.
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Digital health : patient safety and the next frontier
Medical and wearable devices, remote in-vitro diagnostics and digital therapeutic products - the rapidly evolving world of digital health is bringing more and more devices into patients’ hands. But along with the benefits, there are safety considerations for people and data.
