All CPD Supplement articles

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    CPD Supplement

    The Olaratumab experience

    2022-06-09T10:47:00Z

    As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...

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    CPD Supplement

    Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy

    2021-10-01T10:39:00Z

    In April 2019, the Committee for Medicinal Products for Human Use (CHMP) issued a qualification opinion on stride velocity as an endpoint in clinical studies of medicines for the treatment of Duchenne Muscular Dystrophy (DMD).[1] Mutations in the dystrophin gene cause this inherited, x-linked disorder which causes progressive muscle weakness ...

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    CPD Supplement

    Digital health technologies – an overview of EU and US frameworks

    2021-10-01T10:00:00Z

    Digital health technologies have revolutionised the global healthcare system. This continuing professional development supplement provides an overview of the qualification frameworks for digital health technologies, which are used as drug development tools in the EU and the US.

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    CPD Supplement

    CTIS national pilot – Belgium

    2021-04-01T14:06:00Z

    Although the CTIS is still under development, several EU countries (eg, Belgium, France, Germany, Finland and the UK prior to Brexit) are running national pilots to test the new way of working introduced by the Clinical Trial Regulation 536/2014. Pilot conditions in the various countries are different. The Heads of ...

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    CPD Supplement

    The EU Clinical Trial Regulation (EU) No 536/2014-The Clinical Trials Information System

    2021-04-01T13:53:00Z

    This continuing professional development article addresses changes introduced by Regulation (EU) No 536/2014 (the Clinical Trial Regulation/CTR) and focuses on the revised submission process for clinical trial applications in the EU/EEA via the new EU portal

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    CPD Supplement

    Case Study- Luxturna

    2021-02-01T15:35:00Z

    The ATMP Luxturna (voretigene neparvovec) is a GTMP which utilises a recombinant adeno-associated viral vector serotype 2 (rAAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina. Luxturna is approved for patients with retinal dystrophy associated with biallelic RPE65 mutations ...

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    CPD Supplement

    Understanding the basics of ATMP regulation

    2021-02-01T15:29:00Z

    Advanced therapy medicinal products (ATMPs) are biological products which comprise a diverse group of medicinal products that are often complex and diverse in nature. As these products are regularly developed for diseases of high unmet need, the requirements for evidence generation to support marketing authorisation often require innovative development plans. Within this continuing professional development supplement we investigate the regulation of ATMPs in the EU and US [see also Regulatory Rapporteur October 2020 and February 2020 for articles by Harriet Edwards on ATMPs].

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    CPD Supplement

    Expedited drug development regulatory pathways in the EU and the US

    2020-10-01T09:54:00Z

    This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.

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    CPD Supplement

    Creating an integrated summary of immunogenicity report

    2020-05-01T13:43:00Z

    Introduction The purpose of this case study is to illustrate the creation of an integrated summary of immunogenicity report (ISI) that fulfils the recommendations described in current regulatory guidance for the scope of information needed to facilitate assessment of immunogenicity-related risks to support marketing authorisation of novel and biosimilar versions ...

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    CPD Supplement

    Presentation of immunogenicity-related information in regulatory dossiers

    2020-05-01T13:31:00Z

    The purpose of this continuing professional development supplement is to explain how an integrated summary report can be created to consolidate the information required for assessment of immunogenicity-related risks of different types of biopharmaceuticals.

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    CPD Supplement

    The psychological contract and the hierarchy of criteria

    2020-02-01T14:19:00Z

    The following exercise will give some insights into people’s immediate reactions to change. This could apply to you or your teams’ reactions: 1. Start by writing a list of at least ten things that are important to you about your job and what you enjoy about it This will ...

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    CPD Supplement

    How to manage teams through change

    2020-02-01T14:11:00Z

    Within this continuing professional development (CPD) article we introduce some practical models and tools that can be actively utilised to the benefit of any manager who is responsible for implementing change.