All Regulatory Rapporteur articles in January 2022
View all stories from this issue.
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JournalRequirements for the good distribution practice of medicinal products
No standardisation or formal educational framework to practice as a Responsible Person (RP) currently exists across EU countries. The current RP educational and work experience requirements in EU member states are discussed. (Note that the study was conducted before the UK left the EU, so it is included here among the EU member states.)
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JournalSubstance-based medical devices: regulatory challenges and prospects
Substance-based medical devices comprise a diverse group of products that are regulated under the Medical Devices Regulation, which is applicable since 26 May 2021. Compared with the previous legal framework, the MDR has introduced several extensive changes to the regulatory framework for medical devices that also impact on the marketing of substance-based medical devices in the EU…
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EditorialWhat does 2022 have in store for clinical trials?
Although the pandemic is not over yet, as we move forward, we must embrace these advances and not return to ‘business as usual’ despite the challenges such ways of working entail
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1 and 2 June 2021 as a virtual event with over 500 participants globally connected.
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FocusA regulatory lens on an industry imperative: Diversity in clinical research
Although clinical research is evolving alongside new technological advances, the inclusion of diverse populations within clinical trials has been slow. Regulatory professionals are essential stakeholders in the quest for ensuring inclusivity of these groups…
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JournalNonclinical immunogenicity evaluation in toxicology studies of biopharmaceuticals
One of the critical features that determines the clinical efficacy and safety of biotherapeutics, especially therapeutic proteins, is their ability to induce formation of antibodies against themselves. However, the clinical outcome cannot be predicted using the immunogenicity data from nonclinical studies…
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JournalOn the path to adoption of decentralised clinical trials
Decentralised clinical trials (DCTs) offer great potential to improve the clinical trial paradigm, bringing more diversity and less burden to the participants we serve. COVID-19 has driven DCTs, offering greater flexibility to clinical trial patients. More needs to be done to make DCTs a standard option.
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FocusClinical Trial Information System: overview, opportunities and challenges
The implementation of the Clinical Trial Information System (CTIS), from 31 January 2022, will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications, assessment and supervision of trials, while promoting patient safety and transparency…
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