All Europe articles
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Journal What could the future of labelling look like? The Gravitate-Health story
This article introduces the Gravitate-Health digital lens concept and talks about the value of ePI to help understand patient needs.
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JournalElectronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
This article discusses the 2018 e-PIL pilot in Belgium and Luxembourg including the paper and electronic versions of the patient information leaflet.
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JournalThe EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
This interview with Juan García Burgos discusses the upcoming EMA/National Competent Authority electronic product information (ePI) initiative.
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JournalTranslating real-world needs into digital medication tools: Good practices for co-creation with patients
This article discusses the importance of patient engagement in digital health tool development, using the case study of the Gravitate-Health project.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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JournalRealising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
This article summarises key features of the EFPIA paper and discusses how randomised pragmatic trials can be used to aid regulatory decision-making.
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JournalPatient involvement in the regulatory area: Insights into national level dialogues
This article explores the different areas of patient involvement in European NCA regulatory processes.
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JournalThe importance of patient advocacy in the EMA ODD process
This article discusses the role of patient advocacy groups in the orphan drug designation process to incoporate more patient-centred approaches.
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Industry newsNHS app opens access to trials for UK patients
This industry news update looks at the NHS app and the opportunities for patients to take part in clinical trials.
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InterviewFAMHP: The role of the Belgian Agency in advancing public health
This interview with Professor Hugues Malonne, Chief Executive Officer of the Belgian Federal Agency for Medicines and Health Products (FAMHP) discusses the Agency’s role in helping shape regulatory affairs and improving health.
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JournalThe EU Medical Device Regulation: Balancing innovation with regulation
The EU Medical Device Regulation (EU MDR) 2017/745 was introduced in response to the need for tighter regulation of medical devices (MDs) in Europe. However, with the increased regulatory burden, there could be potentially hundreds of unanticipated ramifications, particularly for smaller manufacturers and start-ups. By increasing regulation so significantly in a relatively short time period, the very rules which are designed to protect patients may prevent them from accessing the treatment they need and stifle innovation, as start-ups inevitably struggle under the weight of new requirements. This article assesses the delicate balance between innovation and regulation and analyses the relationship between the two.
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Industry newsNHS Pharmacy First offers an alternative to GPs in England
Pharmacists in England can now provide treatment for seven common health conditions without patients first consulting a doctor.
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JournalControlled substances development – past, present, and future
Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...
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Industry newsPatients warned about falsified Ozempic medication
The EMA has warned patients and healthcare professionals across the EU about pre-filled injection pens falsely labelled as Ozempic.
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Industry newsNICE approves use of Rimegepant in NHS to treat acute migraine
Rimegepant is the first, and only, NICE-recommended treatment for acute migraine and is soon to be made available on the NHS in the UK.
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VideoEuropean Parliament gives first stage approval for revised EMA fees
MEPs in Strasbourg follow the parliament’s health committee’s approval of report to revise how EMA charges.
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VideoChange Across the Medical Device Landscape
InnoScot Health protects the interests of NHS Scotland and believes it is crucial for innovators to get the right regulatory advice.
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FocusProcedure withdrawals within Europe: past trends, impact and communication recommendations
When an application for a new veterinary medicinal product (VMP) is submitted through a MR/DCP, the Applicant has the option to prematurely withdraw their application in the reference member state (RMS) or in one or several of the concerned member states (CMS). This would result in a total or partial withdrawal of the procedure. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv) sent a questionnaire to all national competent authorities…
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JournalThe national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...