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| home > ict > Autumn 2018 |
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 PUBLICATIONS |
International Clinical Trials |
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The GDPR Impact on Data Management
Reviewing the Rulebook
Kaia Koppel and Agnieszka Felicjanczuk at KCR reflect on the implementation of the General Data Protection Regulation and speak about the consequent impacts that are beginning to show themselves.
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Developing a Pharmacovigilance Presence in Japan
Planning and Execution
A great deal must be be considered when expanding and developing a pharmacovigilance presence in Japan. The team at PPD and PPD-SNBL delve into the intricacies of this essential challenge.
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Outsourcing and Vendor Management
Does Size Matter?
Heike Schön at LUMIS International reviews outsourcing during the early stages of clinical trials, providing an insight into what to look for when wrestling with budgets and resources.
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Digital Technologies in Clinical Research Networks
Clinical Connectivity
Andreas Walter and Le Vin Chin at Clinerion discuss modern technologies and how they are being utilised across the clinical research industry to speed up processes and deliver higher quality results.
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Pharmacovigilance in the EU
Quality Upkeep
Some complex requirements must be met to establish a pharmacovigilance system, particularly when it comes to products and patient safety. David Hukin at Quanticate explains more.
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Approvals for Gene-Based Therapy
Navigating Through Uncharted Waters
Medical advancements are commonplace in gene-based trials, but several challenges need to be overcome. The team at Worldwide Clinical Trials explore the safety and ethical side of these specific trials.
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Transforming Cancer Outcomes with Real-World Evidence
Capturing Cancer Evidence
With the ever-evolving measures surrounding patient-reported outcomes, providing the best services to patients is critical, as explained by Dr Tim Williams at My Clinical Outcomes.
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Q&A: An Integrated Approach to First-In-Human Trials
Clinical Complexities
Torkel Gren at Recipharm and Anders Millerhovf at Clinical Trial Consultants spoke to ICT about the differing complexities of first-in-human trials and advise on how to craft an effective journey to market.
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Unifying Clinical Operations
Streamlining Start-Ups
Veeva Systems’Rik Van Mol describes how clinical leaders across the industry are beginning to understand the benefits of unification for clinical operating environments and how strategies are being attained.
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Q&A: Adaptive Trials
Modifying Methods
Dr Sy Pretorius at PAREXEL offers his insight to ICT about how the utilisation of adaptive trial design can improve data collection, as well as increase the chance of overall trial success.
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Patient Travel Assistance
Talking Travel
Hannu Koski and Rob Laurens at BBK Worldwide take a detailed look into the role that transportation can play to ensure patient retention and satisfaction across clinical trials.
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End Point
The Imminent Exit
ICT’s Editor, Dr Graham Hughes, looks ahead to the UK’s exit of the EU and what it may mean for clinical trials and medication in the following year.
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News and Press Releases |
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CPhI China opens with analysis pointing to a surge in growth in 2019
Shanghai, 23rd May 2019: New analysis released ahead of CPhI & P-MEC China (#CPhIChina and #PMECChina) – co-organized by Informa Markets, CCCMHPIE, and Shanghai Sinoexpo Informa Markets – forecasts that China will continue to grow strongly through 2019/20, thanks in part to a marked improvement in its global reputation.
More info >> |
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White Papers |
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Device Develop for Combo Products
Phillips-Medisize
Combination products are defined as therapeutics combining two or more products (drug/device, biologics/device, biologics/drugs or drug/device/biologics), regulated and sold as a single unit. As these pharmaceutical and biological therapies and treatments have evolved, so has the need to develop appropriate delivery mechanisms for these applications. When developing a combination product, there are many things that need to be considered – the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, as well as, device manufacturing variation.
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Industry Events |
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Nordic Life Science Days 10/12 September 2019
10-12 September 2019, Malmo Sweden
Nordic Life Science Days is the largest Nordic partnering conference for the global Life
Science industry.
Bringing together the best talents in Life Science, offering amazing networking and
partnering opportunities, providing inputs and content on the most recent trends.
Nordic Life Science Days attracts leading decision makers from the Life Science sector,
not only from biotech, pharma and medtech but also from finances, research, policy and
regulatory authorities.
More info >> |
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