Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

December 2022  |  Volume 20  |  No.1

EDITORIAL

Waltzing into change in Vienna: the regulatory future comes into focus

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By Pascale Canning  and Julie Warner

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HM1: A decade of innovative clinical trials: what have we learnt and where are we going?

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By Frédéric Pailloux

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HM2: Expedited programmes and accelerated drug development

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By Ségolène Saintpierre

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HM3: Lessons learned and strategic priorities

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By Sobhey Nassar 

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HM4: Assessing the value of innovative therapies: trends, challenges and learnings

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By Claire Levée

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HM5/MD1: Digital health opportunities and advancements in healthcare

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By Célia Cruz

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HM6: Innovations in regulatory science

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By Ségolène Saintpierre

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HM7: Are patients still the missing piece in the global drug development puzzle?

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By Sarah Heraghty

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HM8: The present and future of developing and commercialising cell and gene therapies

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By Nathalie Bourrit

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HM9: Strategy under uncertainty: improving the odds of regulatory success

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By Francesca Buttigieg

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IVD1: Current state: an update on the IVDR implementation

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By Esteban Herrero-Martinez

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IVD2: Clinical performance evaluation challenges

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By Esteban Herrero-Martinez

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IVD3: IVDR for small companies and start-ups

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By Célia Cruz

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MD2: How to approach artificial intelligence and cybersecurity now and in the future

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By Mehryar Behizad

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MD3: Clinical investigation from a virtual setting perspective

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By Mehryar Behizad

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MD4: Challenges and opportunities for small companies and start-ups

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By Michael Kipping

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MD5: How to maintain your medical device on the market

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By Mehryar Behizad

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VM1: Availability and innovation: under a new VMP legislation

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By Rhona Banks

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VM2: Novel therapies in animal health: balancing guidance versus gaining flexibility

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By Mel Munro

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VM3: Antimicrobials: the new rules, their impact, and consequences

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By Beate Lohr

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VM4: Regulatory update and perspectives

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By Kornelia Grein

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VM5: CVMP guidelines update

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By Pascale Canning