All Symposium articles – Page 2
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Meeting ReportIVD3: EU Implementation: Current State
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
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Meeting ReportMD3: Digitalisation: How to bring paradise into regulatory work
Martin Witte chaired and introduced this interesting session, which considered the digitalisation of medical device regulatory information –using technology to allow more effective interrogation and control of available data…
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Meeting ReportMD1: MDR implementation – is there a future for legacy devices?
The first speaker for this session was Derek Foit. He defined legacy devices per Article 120 MDR, provided examples of class I to class III devices including nanoparticles, nasal sprays as specific cases…
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Meeting ReportVM2: Encouraging specific investments
Session 2 co-chaired by Beate Lohr and Emily Drury looked into specific opportunities opened up by the Veterinary Medicines Regulation intended for limited markets (Article 23) and for gaining additional data protection through defined post-authorisation product developments (Article 40(5)).
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Meeting ReportVM1: Regulatory science – focus on biologicals
Opening the session, Ivo Claassen spoke about the unprecedented situation of the COVID-19 pandemic and the effects it has had on regulatory adaptation and emergency response preparedness. It was remarkable that novel mRNA vaccines for humans were developed and licensed in such a short period. He believes that there will be a considerable impact on the regulatory landscape in the long term.
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Meeting ReportHM8: 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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Meeting ReportHM7: 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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Meeting ReportHM5: 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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Meeting ReportHM4: 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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Meeting ReportHM2: 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.
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Meeting ReportHM10: 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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Meeting ReportIVD5: How do I Implement IVDR? Some key practicalities
This session looked at the practicalities of IVDR implementation and considered how to prepare application documents, the expectations for performance evaluation (PE) and postmarketing clinical follow-up (PMCF).
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Meeting ReportListening is only the first step
From ‘Knocking on the door’ to co-creation: 25 Years of patient engagement in R&D: Virginie Hivert, Therapeutic Development Director, EURORDIS, reflects on the evolution of patient engagement in the rare diseases field, emphasising the importance of collaboration between stakeholders and patients.
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