All Journal articles – Page 13
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JournalVM5: Digital innovation to support animal health
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jana Schalansky, Head of Veterinary Strategic Support, Veterinary Medicines Division, EMA, the Netherlands. Speakers: Ricardo Carapeto García, Head of Area and Environmental Risks, AEMPS, ...
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JournalIVD5: Class D IVDs
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session Leader Amanda Brown, Director of Quality and Regulatory Affairs, HP, Germany. Ashleigh Batchen, Regulatory Strategy Principal (UK), TÜV SÜD, UK. Speakers and panelists Olga Tkachenko, ...
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JournalMD5: Post-market challenges
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Natasha Bankowski, Director of Regulatory Affairs and Quality Assurance, Beyond Air Ireland Ltd, Ireland. Speakers: Richard Vincins, VP Global Regulatory Affairs, Oriel STAT A MATRIX, ...
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JournalHM6: Real-world evidence and the use of big data for regulatory decision making; DARWIN EU
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Marén Koban, Director Global Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany. Àlmath Spooner, Head of Europe, Regulatory Policy and Intelligence, Abbvie, Ireland. Speakers: ...
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JournalHM7: Paediatric investigational plans
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chairs: Sandra Lourenco, Head of Regulatory Affairs, Arriello, Portugal. Andrea Laslop, Head of Scientific Office, Austrian Medicines and Medical Devices Agency, Austria. Speakers: Ignacio Malagon ...
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JournalHM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Marie Uguen, Senior VP, Regulatory Affairs & Quality Assurance, SparingVision, France. Speakers: Laurence Campion, Regulatory Affairs Director, PTC Therapeutics France, France. Christian K. Schneider, ...
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JournalHM9: Patient engagement in the regulatory lifecycle of medicines
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session Leaders Fred Senatore, Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, U.S. Food and Drug Administration ...
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JournalTOPRA Annual lecture
Dr Miguel Forte started his lecture by describing the fantastic cell and gene therapies (C>) opportunity for patients and other stakeholders in the pharmaceutical industry; he described a complex business with significant investment and value to patient in oncology and rare disease.
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JournalHM4: The evolving clinical trial landscape
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Carlos Alves - Vice President, Infarmed, Portugal Speakers: Olga Kholmanskikh, Clinical Assessor, Federal Agency for Medicines and Health Products (FAHMP), Belgium. Björn Eriksson, Director ...
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JournalTransitioning from paper to electronic IFU for EU MDR 2017/745
The European Union Medical Device Regulation (EU MDR) Regulation (EU) 2017/745[1] amends current the EU Medical Device Directive (MDD) ‘93/42/EEC’ and the EU Active Implantable Medical Device (AIMD) ‘90/385/EEC’ directives. The regulation governs the manufacturing and supply of medical devices in the European Region and its territories. Several significant changes ...
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JournalMedical device standards update: November 2023
This edition of our regular column updates the progress of applicable standards to October 2023.
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JournalAccess consortium: in the current submission transmission ecosystem
The Access Consortium is a medium-sized coalition of regulatory authorities that work together to promote greater collaboration and alignment of regulatory requirements. This union began in 2007 with the involvement of Australia, Canada, Singapore, and Switzerland, and was later in 2021 bolstered by the addition of the United Kingdom’s Medicines ...
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JournalOverview of importation
strategy from an
FDA perspective
– PLAIR vs FTZIn the current landscape, pharmaceuticals and biologics are manufactured at global current good manufacturing practice facilities for distribution in the US market. The importation of these products is a crucial process, as it ensures that patients can access these products in a timely fashion upon approval of applications to health ...
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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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JournalA harmonised approach to clinical data standards
David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.
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JournalAutogenous vaccines under Regulation (EU) 2019/6
Through Regulation (EU) 2019/6, it has been the first time that so-called autogenous vaccines (AVs) are included in the EU legislation that rules veterinary medicinal products. Described as inactivated vaccines which are manufactured from pathogens obtained from animals in an epidemiological unit, they are restricted to the ...
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JournalEMA activities related to antiparasitic veterinary medicinal products
Antiparasitic medicines rightly play an important role in veterinary medicine, as antiparasitic diseases can have important impacts on animal health and welfare and are economically significant. Antiparasitic veterinary medicinal products (VMPs) are evaluated under the same thorough licensing procedure as all other veterinary medicines before they are authorised, and are ...
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JournalOptimal materials selection in medical device development – a proactive biocompatibility approach
Regulatory Rapporteur October 2023 | Volume 20 | No.9 Introduction Biocompatibility evaluation of medical devices is a complex task related to various factors that include mainly chemical nature and physical properties of the material, the ...
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JournalTransition to the new QRD template for veterinary medicines: challenges and opportunities
The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...