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  1. Article ; Online: From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety.

    Bolislis, Winona Rei R / Mortazavi, Charlie / Riccioni, Rossana / Schaeffer, Paul-Etienne / Kühler, Thomas C

    Therapeutic innovation & regulatory science

    2019  Volume 54, Issue 4, Page(s) 831–838

    Abstract: Patient information leaflets (PILs) differ across regulatory jurisdictions-its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important ... ...

    Abstract Patient information leaflets (PILs) differ across regulatory jurisdictions-its form and structure are dependent on the regulations it conforms to. Yet, physical or paper-based documents remain to be the most prevalent way of delivering important information to patients. As technology continues to enhance our daily activities, patients are increasingly utilizing digital platforms to facilitate access to relevant product information, hence questioning the continuous viability of physical PILs. This paper aims to present the growing importance of transitioning from print to screen via dynamic electronic product information, as a way of expanding access and utility of patient information. It provides considerations or reflection points for regulators when adopting digital platforms to ensure that stakeholders, especially patients, receive trusted and real-time information on available and approved medicinal products. We underscore these with examples and case studies from countries and businesses that have adopted or are transitioning to such platforms.
    MeSH term(s) Child ; Humans ; Patient Safety/standards ; Pharmaceutical Preparations
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2019-12-09
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-019-00018-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide : Joint Position from EFPIA, IFPMA and Vaccines Europe.

    Deavin, Andrew / Adam, Sarah / Ausborn, Susanne / Nielsen, Ane Sofie Böhm / Cappellini, Sonia / Colmagne-Poulard, Isabelle / Gastineau, Thierry / Gonzalez-Martinez, Arturo / Meillerais, Sylvie / Mortazavi, Charlie

    Therapeutic innovation & regulatory science

    2022  Volume 57, Issue 1, Page(s) 7–11

    Abstract: Post-approval changes (PACs) to the registered information of authorised medicinal products are introduced routinely worldwide to enhance the robustness and efficiency of the manufacturing process, ensure timely supply in case of increased demand, ... ...

    Abstract Post-approval changes (PACs) to the registered information of authorised medicinal products are introduced routinely worldwide to enhance the robustness and efficiency of the manufacturing process, ensure timely supply in case of increased demand, improve quality control techniques, respond to changes in regulatory requirements and upgrade to state-of-the-art facilities. These are critical to prevent supply disruption and continuously improve existing medicines and vaccines. Due to the complexity of current PAC systems across markets, a change can take 3 to 5 years to approval globally (Hoath et al in BioProcess Int, 2016) thus hindering innovation and increasing the risk of shortages. The key messages are as follows: 1. Industry believes that global regulatory convergence of post-approval changes to Marketing Authorisations (MAs) using science- and risk-based approaches will enable a more efficient management of quality and supply improvements and will facilitate patients' access to innovative medicines and vaccines of the highest quality. 2. National Regulatory Authorities (NRAs) should establish national or regional guidelines in line with international standards (regarding a risk-based classification of changes and standardisation of requirements) (Guidelines on procedures and data requirements for changes to approved biotherapeutic products, in WHO Technical Report Series, 2018, Guidelines on procedures and data requirements for changes to approved vaccines, in WHO Technical Report Series, 2015), have clear procedural guidance including timelines and implement reliance pathways to accelerate the approval of changes. This paper briefly outlines the challenges for PACs and provides solutions for a more flexible and aligned global system.
    MeSH term(s) Humans ; Change Management ; Europe ; Vaccines ; Marketing ; Quality Control
    Chemical Substances Vaccines
    Language English
    Publishing date 2022-08-02
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-022-00426-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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