All Journal articles – Page 2

  • PS2
    Journal

    PS2: ATMP innovations and clinical trials with genetically modified organisms

    2023-12-05T16:00:00Z

    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, ...

  • 2D4A5460
    Journal

    HM2: Improving the odds of regulatory success

    2023-12-05T16:00:00Z

    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 ...

  • VM1_Rick Clayton
    Journal

    VM1: Horizontal legislation and veterinary medicine availability

    2023-12-05T16:00:00Z

    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 ...

  • 2D4A4912
    Journal

    HM1: Update on EU new regulatory legislation − EMA, industry and others

    2023-12-05T16:00:00Z

    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 ...

  • PS1
    Journal

    PS1: Health technology assessment – the new EU regulation

    2023-12-05T16:00:00Z

    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: ...

  • RR-Dec-2023-Cover
  • HM4_Panel
    Journal

    HM4: The evolving clinical trial landscape

    2023-11-07T15:25:00Z

    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 ...

  • AdobeStock_659335173
    Journal

    Overview of importation strategy from an FDA perspective – PLAIR vs FTZ

    2023-11-03T00:05:00Z

    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 ...

  • Med-Devices
    Journal

    Medical device standards update

    2023-11-03T00:05:00Z

    This edition of our regular column updates the progress of applicable standards to October 2023.

  • AdobeStock_540782876
    Journal

    Controlled substances development – past, present, and future

    2023-11-03T00:05:00Z

    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, ...

  • AdobeStock_628375803
    Journal

    Access consortium: in the current submission transmission ecosystem

    2023-11-03T00:05:00Z

    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 ...

  • AdobeStock_621951357
    Journal

    Transitioning from paper to electronic IFU for EU MDR 2017/745

    2023-11-03T00:05:00Z

    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 ...

  • Interview
    Journal

    A harmonised approach to clinical data standards

    2023-11-02T00:05:00Z

    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.  

  • AdobeStock_659335173
    Journal

    November 2023 – Contents

    November 2023  |  Volume  20  |  No.10

  • AdobeStock_615367735 (1)
    Journal

    Prequalification of veterinary vaccines and medicines

    2023-10-02T15:30:00Z

    An initiative to assure the quality of veterinary medicinal products for use in animal health programmes to support humanitarian assistance.

  • AdobeStock_626499876
    Journal

    Transition to the new QRD template for veterinary medicines: challenges and opportunities

    2023-10-02T15:30:00Z

    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, ...

  • MedDevMat
    Journal

    Optimal materials selection in medical device development – a proactive biocompatibility approach

    2023-10-02T15:30:00Z

    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 ...

  • Dog receiving flea treatment
    Journal

    EMA activities related to antiparasitic veterinary medicinal products

    2023-10-02T15:30:00Z

    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 ...

  • RR-Oct-2023-Cover
    Journal

    October 2023 – Contents

    October 2023 | Volume 20 | No.9

  • AdobeStock_552256917
    Journal

    Autogenous vaccines under Regulation (EU) 2019/6

    2023-10-02T15:30:00Z

    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 ...