Merck Serono to deliver an opening address on Totality of Evidence and Residual Risk | Biosimilars and Biobetters

Top Quote This year's conference will address regulatory updates, pharmacovigilance of biosimilars, patent litigation, market access, product commercialization barriers and global market developments. End Quote
  • (1888PressRelease) August 14, 2015 - SMi's 6th annual Biosimilars and Biobetters conference, taking place on 30th September - 1st October 2015 in London, will provide the ideal platform to engage in scientific discussions and debate the best practices and solutions to improve industry performance through technical case studies and practical advice from leading biosimilar and regulatory players from organisations including Harvest Moon Pharmaceuticals USA Inc, GfK, MHRA, Selecta Biosciences, Cinfa Biotech GmbH, Norwegian Medicines Agency and more.

    Unique perspectives will be shared on:
    Evolving biosimilar regulatory landscape
    Market access and product commercialisation barriers
    Global marketing developments, including a focus on emerging market trends
    In-depth protein characterisation and analytical comparability to efficiently and effectively collect data

    Furthermore, we are delighted to announce that Merck Serono's Head of Safety - Biosimilars, Uwe Gudat, will be leading an opening address on Day 2 of SMi's 6th annual Biosimilars and Biobetters conference titled 'Safety First! "Totality of Evidence" and Residual Risk'. He will be sharing his insight on the following topic areas:
    Building the bridge between analytical characterization and clinical safety
    How much confidence on safety can the clinical program offer?
    Can we extrapolate safety across indications?
    Explaining "totality of evidence" to reassure clinicians
    Tailored post-launch pharmacovigilance: not too little, nor too much

    To view the full speaker line-up and conference programme, visit

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