The 2025 Awards will open for entries in March 2025 - more details to follow shortly.

Nominations for the 2025 TOPRA Awards for Regulatory Excellence will open in March 2025.

The Innovation Award honours outstanding achievements in the deployment and successful implementation of innovative ideas, which could include new ideas for efficiency, productivity and processes.


The focus is on recognising outstanding achievements, delivered in the past three years, in the deployment and successful implementation of innovative ideas, together with rewarding individuals or organisations that embrace new and advanced ways to enhance the regulatory affairs profession.

 

This award category is open to individuals, teams and organisations

Nominations may cover:

1. The development of an approach, idea, or practice which enhances the regulatory profession by introducing a better way of conducting business.
2. A publication or piece of research that provides interpretation in a complex regulatory situation.
3. A technological advance in providing solutions to regulatory professionals.

Read our Information Pack for more details about the Awards and FAQs.

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Previous winners and finalists

WINNER – CAPTIS team, Celegence, UK, USA, the Netherlands, Romania and India
FINALIST - Dossplorer team, Celegence, USA and the Netherlands
FINALIST - Global Regulatory Intelligence (GRI) Freyr Solutions, India
FINALIST - Roche, UK, Switzerland and USA
WINNER – NHS COVID-19 App Regulatory Team, UK 
FINALIST - Association of Clinical Research Organizations (ACRO), US
FINALIST - DEEP-EFPIA collaboration, Finland/Belgium
FINALIST - Sanofi Regulatory Reliance CMC PAC Pilot Team, Canada

WINNER – Global Digital Assurance Team, AstraZeneca, USA 
FINALIST - Mark Bailey, Associate Director of Regulatory Operations, Syneos Health, Australia
FINALIST - Leslie Kitchen, Senior Director, Innovation & Information Management, Merck & Co, on behalf of the RTQ Biographer Team, USA 

WINNER – VCLS In Silico Team, Voisin Consulting Life Sciences, France
FINALIST - First fully decentralized trial in Oncology, F.Hoffmann La Roche, Switzerland
FINALIST - The eConsent Implementation Guide - a EUCROF & eClinical Forum member collaboration, co-chaired by Medidata and Signant Health 

WINNER - Regulatory Process Automation Factory, F Hoffmann-La Roche, Switzerland
FINALIST - Association of Clinical Research Organisations (ACRO) and the Decentralised Clinical Trials Working Party, UK
FINALIST - COVID-19 antiviral expedited clinical trial start-up, Regulatory Affairs Team, including Lisa Huang, Pedro Inacio, Michael Park and Christina Cocciardo, PPD, Taiwan, Portugal, Korea and USA
FINALIST - GRAvitate Hackathon and the Agile Methodology – Propelling Sanofi GRA Digital Transformation, including Mathieu Buonafine, Mickael Osseni, Michelle Halliez, Sima Desai, Elise Lefebvre, Sanofi GRA, France, USA and the Netherlands
FINALIST - Labelling Process and Documentation Redesign (LPDR), Merck Sharp & Dohme, Kenilworth, New Jersey, USA 
FINALIST - Team DocXter, led by Hrishikesh Dhongade and Sujatha Muttavarapu, Novartis Pharmaceutical Corporation, India and USA

WINNER - MedBoard, UK
FINALIST - Business Workflow Enablement for Labeling (BWEL), Merck & Co, Inc, USA (BWEL Leads: Anita Cunningham, Exec Director Global Labeling Regulatory Affairs, John Janick, Director Innovation & Information Management, Jamie Brubaker Hall, Director Labeling Operations Innovation & Information Management)
FINALIST - Joyce Tait, Co-Director, Innogen Institute, University of Edinburgh, UK

WINNER - Viagra Connect Team - Pfizer, UK
FINALIST - eIFU Service - Qarad, Belgium
FINALIST - Stuart McCully - Syneos Health, UK