Human Medicines Stories

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    HM5: Reliance, worksharing and recognition as 21st century regulatory tools


    Francesca Buttigieg introduced this session on reliance, worksharing and recognition as 21st century regulatory tools. Murray Lumpkin gave the opening presentation, giving a strong justification for the use of work-sharing and reliance as a use of best practice by all regulatory authorities (RAs), not just the smaller, less known RAs….

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    HM4: Real world evidence in regulatory decision-making


    During the first part of the session, Fred Senatore discussed applications and the challenges of real word data (RWD) and real-world evidence (RWE). He opened his talk with a definition of the two, with RWD being defined as the data collected from a variety of sources, and RWE as the analysis of the source.

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    HM8: Enhancing dialogue to foster innovation


    Susan Bhatti welcomed the speakers and highlighted the importance of having an iterative, responsive and holistic regulatory dialogue with a flexible scientific advice process and an alignment across the stakeholders. The recent example of the pandemic has emphasised the importance of having proactive measures and time-efficient interactions with health authorities.

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    HM1: Spotlight on CEE – challenges and opportunities in the region


    The first session of this virtual symposium was opened by Eva Kopecna, who introduced three speakers, two of whom represented two different regulatory agencies – the Czech State Institute for Drug Control (SÚKL), which is part of the EU regulatory community, and the Russian State Institute of Drugs and Good Practices (SID&GP).

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    HM6: Clinical trials of the future – patient orientated and digitally connected


    Susan Bhatti started the session by welcoming everyone and clarifying that the aim of the meeting was to discuss how clinical trials can be transformed by using digital technologies to enrol and monitor patients, resulting in more inclusive, flexible, connected and patient-centred studies.

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    HM3: Evolution of EMA-EUnetHTA collaboration across decision makers


    This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.

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    HM7: Regulatory progress in delivering on the promise of ATMPs


    Tomáš Borán introduced the presenters, co-chair and panellists for this session, discussing the regulatory progress in delivering on the promise of advanced therapy medicinal products (ATMPS)

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    HM10: Scenarios to Consider Risk


    This interactive session focused on how to develop and successfully implement a regulatory strategy. Participants were given the opportunity to analyse different scenarios and compare answers with the panellists who provided practical advice on ways to avoid potential pitfalls and disastrous mistakes.

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    HM2: Fireside chat with Emer Cooke: a review of current and future priorities


    This session was a conversation between Daniela Drago and Emer Cooke. Ms Drago began by asking Ms Cooke to reflect on her first ten months leading the European Medicines Agency (EMA). She was quick to respond: “It has been incredible, a privilege”, adding that it is an exciting time for medicines regulation in Europe and, indeed, the world.