All Journal articles – Page 2
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JournalPS2: ATMP innovations and clinical trials with genetically modified organisms
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jayne Hunt, Principal Regulatory Affairs Consultant, Ariello. Speakers: Patrick Ginty, Boyds Consultants. Isabel Borba Vieira, Nonclinical Assessor at Medicines Evaluation Department Scientific Evaluation Unit, ...
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JournalHM2: Improving the odds of regulatory success
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader and speaker: Carlos Langezaal, Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA. Speakers: Fred Senatore, Medical Officer, Clinical Team Leader Division of ...
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JournalVM1: Horizontal legislation and veterinary medicine availability
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Rick Clayton, Technical Director, AnimalhealthEurope, Belgium. Speakers: Jaume Colomer, Senior Technical Manager, AnimalhealthEurope, Belgium. Nancy De Briyne, Executive Director of the Federation of Veterinarians ...
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JournalHM1: Update on EU new regulatory legislation − EMA, industry and others
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Leaders: Marta Marcelino, Head of Medicines Evaluation Department, PT CMDh Member, Infarmed, Portugal. Julie Taccoen, senior Director Regulatory Affairs, PTC Therapeutics, France. Speakers: Olga Solomon, Head ...
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JournalPS1: Health technology assessment – the new EU regulation
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Mariane Cossito, Head of Medicines Evaluation and Access Management Unit, Infarmed, Portugal. Carlos Langezaal, Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA. Speakers: ...
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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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JournalOverview of importation strategy from an FDA perspective – PLAIR vs FTZ
In 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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JournalMedical device standards update
This edition of our regular column updates the progress of applicable standards to October 2023.
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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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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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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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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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JournalPrequalification of veterinary vaccines and medicines
An initiative to assure the quality of veterinary medicinal products for use in animal health programmes to support humanitarian assistance.
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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, ...
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JournalOptimal materials selection in medical device development – a proactive biocompatibility approach
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 contact tissue and duration of contact. Its assessment aims to predict whether a material could potentially pose risks to patients under conditions that closely ...
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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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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 ...