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  • PROGRAMME ERTC Wshop Barcelona 20 June 08

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    spalt7458
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    This document outlines the programme for the 8th Workshop of the Eurordis Round Table of Companies on the topic of "Impact of the EU Paediatric Regulation on Orphan Drug Development". The one-day workshop in Barcelona, Spain includes presentations from the EMEA, FDA, industry representatives, patient representatives, and others on understanding the EU Paediatric Regulation, experiences from the first year of the Paediatric Committee, the challenges of orphan and paediatric drug development, ethical issues in paediatric clinical trials, and a discussion on facilitating drug development for paediatric and orphan indications.

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    This document outlines the programme for the 8th Workshop of the Eurordis Round Table of Companies on the topic of "Impact of the EU Paediatric Regulation on Orphan Drug Development". The one-day workshop in Barcelona, Spain includes presentations from the EMEA, FDA, industry representatives, patient representatives, and others on understanding the EU Paediatric Regulation, experiences from the first year of the Paediatric Committee, the challenges of orphan and paediatric drug development, ethical issues in paediatric clinical trials, and a discussion on facilitating drug development for paediatric and orphan indications.

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    Attribution Non-Commercial (BY-NC)
    Téléchargez comme DOC, PDF, TXT ou lisez en ligne sur Scribd
    Signaler comme contenu inapproprié
    31 vues2 pages

    PROGRAMME ERTC Wshop Barcelona 20 June 08

    Transféré par

    spalt7458
    This document outlines the programme for the 8th Workshop of the Eurordis Round Table of Companies on the topic of "Impact of the EU Paediatric Regulation on Orphan Drug Development". The one-day workshop in Barcelona, Spain includes presentations from the EMEA, FDA, industry representatives, patient representatives, and others on understanding the EU Paediatric Regulation, experiences from the first year of the Paediatric Committee, the challenges of orphan and paediatric drug development, ethical issues in paediatric clinical trials, and a discussion on facilitating drug development for paediatric and orphan indications.

    Droits d'auteur :

    Attribution Non-Commercial (BY-NC)
    Téléchargez comme DOC, PDF, TXT ou lisez en ligne sur Scribd
    Signaler comme contenu inapproprié
    sur 2

    8th Workshop

    Eurordis Round Table of Companies

    “Impact of the EU Paediatric Regulation on Orphan Drug Development”

    June 20th, 2008


    Barcelona, Spain

    Sant Antoni Maria Claret, 171


    Fundació Doctor Robert - Universitat Autònoma de Barcelona- Casa Convalescència

    Programme
    8:30 Welcome & coffee
    MORNING 9:00 - 12:50
    Chairpersons:
    Dr Daniel Brasseur (Chair of the PDCO, EMEA) – Prof. Josep Torrent-Farnell (COMP, EMEA)
    9:00 - 9:15 Welcome address

    9:15 - 9:35 “Understanding the EU Paediatric Regulation”


    (Dr Christoph Male, member of the PDCO, EMEA)
    We intend to present the aims and the content of the EU Regulation.

    9:35 -10:00 “The Paediatric Committee of the EMEA: Experiences of the First Year”
    (Dr Paolo Tomasi, EMEA)
    A report from the experience of the PDCO both on orphan and non-orphan drugs, and perspectives for the future.

    10:00 -10:40 Discussion (40’)

    10:40 - 11.00 – COFFEE BREAK

    11:00 – 11:30 “The Double Challenge of Orphan and Paediatric: the US Experience”
    (Dr Linda C. Ulrich, FDA/Office of Orphan Products Development)

    11:30 – 12:10 “Industry Experience and Evaluation of the Legislative Framework”


    (Dr Thomas Severin, Novartis and Mrs Marie-Christine Fortun, Orphan Europe)

    12:10 – 13:00 Discussion (40’)

    13:00 -14:15– LUNCH

    1/2
    AFTERNOON 14:15 -16:30
    Chairpersons:
    Dr Kerstin Westermark (Chair of the COMP, EMEA) – Mr Yann Le Cam (CEO of EURORDIS)

    14:15 -14:35 “The Role of Patients in the EU Paediatric Legislative and Non-legislative
    Framework” (Dr Tsveta Schyns, patient representative, candidate to the PDCO)

    14:35 -14:55 “Ethical Issues for the Involvement of Children in Clinical Trials “
    (Dr Paola Baiardi, TEDDY network)
    The public perception of paediatric trials and the policies for access to data on paediatric drug development
    will also be discussed

    14:55 -16:30 Discussion with panel including all stakeholders:


    “How to Facilitate the Development of Drugs in Paediatric and Orphan Indications?”

    Panel members: Speakers

    16:30 End of Workshop

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