Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

November 2024  |  Vol. 21  |  No. 10

EDITORIAL

Improving health outcomes through regulatory excellence

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By Kornelia Grein, Sobhey Nassar and Marie Uguen

HUMAN MEDICINES

HM1: Ensuring regulatory excellence

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By Sandra Lourenço

HUMAN MEDICINES

HM2: European clinical research ecosystem – How to boost its competitiveness  

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By Natasha Bankowski

HUMAN MEDICINES

HM3: Regulation and innovation – Keeping up with the times (Fireside chat)

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By Céline Combet

HUMAN MEDICINES

HM4: Electronic product information (ePI) – A digital passport for medicinal product information

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By Sarah Heraghty

HUMAN MEDICINES

HM5/MD1/IVD1: COMBINE project: A new era of combined clinical trials in Europe

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By Erica Cypas and Charlotte Holleran

HUMAN MEDICINES

HM6: Artificial Intelligence – How will AI and machine learning tools transform regulatory practice?

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By Natasha Bankowski

HUMAN MEDICINES

HM7: Clinical evidence generation in Europe – Is it time for a more holistic view of global healthcare product development?

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By Michelle Blake

HUMAN MEDICINES

HM8: How the new EU regulation on health technology assessment (HTA) will change clinical drug development and regulatory affairs   

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By David Uguen

HUMAN MEDICINES

HM9: Clinical trial applications – EU Clinical Trial Regulation (CTR) and beyond

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By Christine Grew

PARALLEL SESSION

PS1: Resolving specific development hurdles via scientific advice

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By Ophélie Poujade

PARALLEL SESSION

PS2: Patient experience data – The next steps towards medicines evaluation

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By Anna Koptina

SME, ACADEMIA AND START-UPS

SME: Regulatory updates for SME, academia and start-ups

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By Marie Uguen

ANNUAL LECTURE

The TOPRA annual lecture: Status of global health 

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By Margareth Jorvid