Regulatory
Rapporteur
Write to the Editor at publications@topra.org
November 2024 | Vol. 21 | No. 10
EDITORIAL
Improving health outcomes through regulatory excellence
By Kornelia Grein, Sobhey Nassar and Marie Uguen
HUMAN MEDICINES
HM1: Ensuring regulatory excellence
By Sandra Lourenço
HUMAN MEDICINES
HM2: European clinical research ecosystem – How to boost its competitiveness
By Natasha Bankowski
HUMAN MEDICINES
HM3: Regulation and innovation – Keeping up with the times (Fireside chat)
By Céline Combet
HUMAN MEDICINES
HM4: Electronic product information (ePI) – A digital passport for medicinal product information
By Sarah Heraghty
HUMAN MEDICINES
HM5/MD1/IVD1: COMBINE project: A new era of combined clinical trials in Europe
By Erica Cypas and Charlotte Holleran
HUMAN MEDICINES
HM6: Artificial Intelligence – How will AI and machine learning tools transform regulatory practice?
By Natasha Bankowski
HUMAN MEDICINES
HM7: Clinical evidence generation in Europe – Is it time for a more holistic view of global healthcare product development?
By Michelle Blake
HUMAN MEDICINES
HM8: How the new EU regulation on health technology assessment (HTA) will change clinical drug development and regulatory affairs
By David Uguen
HUMAN MEDICINES
HM9: Clinical trial applications – EU Clinical Trial Regulation (CTR) and beyond
By Christine Grew
PARALLEL SESSION
PS1: Resolving specific development hurdles via scientific advice
By Ophélie Poujade
PARALLEL SESSION
PS2: Patient experience data – The next steps towards medicines evaluation
By Anna Koptina
SME, ACADEMIA AND START-UPS
SME: Regulatory updates for SME, academia and start-ups
By Marie Uguen
ANNUAL LECTURE
The TOPRA annual lecture: Status of global health
By Margareth Jorvid
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