Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

December 2023  |  Vol. 20  |  No.11

EDITORIAL

Advancing global healthcare together

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By Davina Stevenson

HUMAN MEDICINES

HM1: Update on EU new regulatory legislation and a view from different angles

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By Frederic Pailloux

HUMAN MEDICINES

HM2: Improving the odds of regulatory success

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By Celine Combet

HUMAN MEDICINES

HM3: A spotlight on the future – fireside chat

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By Margarida Morgado

HUMAN MEDICINES

HM4: The evolving clinical trial landscape

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By Carla Gomes

HUMAN MEDICINES

HM5/MD1/IVD1: Process for regulations and implications of different legislation

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By Joan Boren

HUMAN MEDICINES

HM6: Real-world evidence and the use of big data for regulatory decision making

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By Margarida Morgado

HUMAN MEDICINES

HM7: Paediatric investigational plans

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By David Uguen

HUMAN MEDICINES

HM8: Regulatory mechanisms to expedite drug development and patient access

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By Margarida Morgado

HUMAN MEDICINES

HM9: Patient engagement in the regulatory lifecycle of medicines

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By Margarida Morgado

HUMAN MEDICINES

PS1: Health technology assessments – the new EU Regulation

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By Maria Nieto-Gutierrez

HUMAN MEDICINES

PS2: ATMP innovations and clinical trials with genetically modified organisms

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By Davina Stevenson

MEDICAL DEVICES/IVDs

MD2/IVD2: Medical technologies: a catalyst for regulatory innovations

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By Célia Cruz

MEDICAL DEVICES/IVDs

MD3: Navigating the regulatory maze: challenges of medical device software

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By Hasnaa Fatehi

MEDICAL DEVICES/IVDs

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

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By Célia Cruz

MEDICAL DEVICES/IVDs

MD5: Post-market challenges

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By Mehryar Behizad

MEDICAL DEVICES/IVDs

IVD3: IVDR: the current state

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By Mehryar Behizad

MEDICAL DEVICES/IVDs

IVD4: How to manage diverging regulatory strategies within a global market

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By Ashleigh Batchen

MEDICAL DEVICES/IVDs

IVD5: Class D IVDs

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By Hasnaa Fatehi

VETERINARY MEDICINES

VM1: Horizontal legislation and veterinary medicine availability

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By Rick Clayton

VETERINARY MEDICINES

VM2: New initiatives in regulatory science

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By Rhona Banks

VETERINARY MEDICINES

VM3: Regulatory exchange and new/future approaches

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By Mel Munro

VETERINARY MEDICINES

VM4: Living with post-authorisation obligations

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By Anja Holm

VETERINARY MEDICINES

VM5: Digital innovation to support animal and public health

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By Kornelia Grein

ANNUAL LECTURE

TOPRA Annual Lecture

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By Julien Douilet

UPCOMING TOPRA COURSES

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