2020 Finalists

The finalists for the 2020 Awards for Regulatory Excellence were announced on 10 September online at a special virtual event.

Now entering its second decade, the Awards showcase the contribution and achievement of individuals, teams and organisations across the global regulatory affairs community. Despite disruptions of the COVID-19 pandemic, this year’s entries are as high quality and diverse as ever, including nominations from regulatory professionals working in 15 countries across Europe, Asia, North America and South America. Of course not everyone can make the shortlists – and with so many high-calibre entries the independent judging panel had to make some difficult choices. TOPRA is pleased to announce the 2020 finalists:

Communications Stars COMMUNICATION
  • Michael Day, Senior Director, Regulatory Science and Co-Head, Complex Biologics, Voisin Consulting Life Sciences, USA
  • Monir El Azzouzi for The Medical Device made Easy Podcast, CEO, Easy Medical Device GmbH, Switzerland
  • Regulatory COVID-19 Task Force, led by Louise Hayes (Global Regulatory Lead) and Nafsika Kronidou Horst (Franchise Head Oncology), Roche, Switzerland, UK and USA
Contribution stars 

CONTRIBUTION

  • Hina Dixit, Regulatory Manager, New Product Evaluations, Norgine, UK
  • Jane Howard-Jones, Senior Director International RA, Gilead Sciences, UK
  • Mary Ryan, Quality Assurance and Regulatory Affairs Director, Penlon, UK
  • Pierre Omnes, ED, SSU & Regulatory, Syneos Health, France
  • Ruediger Pankow, Principal Consultant Regulatory Affairs, Parexel International, Germany
Education stars

EDUCATION

  • BSc Pharmaceutical Science with Regulatory Affairs Course Team, Kingston University, UK
  • Faster Filing Knowledge Cycling team, led by Detlef Hold, Maxine Warren, Lincoln Shand, Therese Mainville, Roche/Genentech, Switzerland and USA
  • Regulatory Team at Triveritas Ltd – a knoell company (global)
Horizon stars 

HORIZON

  • Misae Takahashi, Regulatory Associate, Syneos Health Clinical KK, Japan
  • Shaziya Saiyed, Regulatory Affairs Associate and Pharmacist, Rapport Global Strategic Services, UK
  • Tobias Fleischmann, Principal Regulatory Affairs Specialist, PPD, Germany
Innovation stars 

INNOVATION

  • Association of Clinical Research Organisations (ACRO) and the Decentralised Clinical Trials Working Party, UK
  • 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
  • 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
  • Labelling Process and Documentation Redesign (LPDR), Merck Sharp & Dohme, Kenilworth, New Jersey, USA 
  • Regulatory Process Automation Factory, F Hoffmann-La Roche, Switzerland
  • Team DocXter, led by Hrishikesh Dhongade and Sujatha Muttavarapu, Novartis Pharmaceutical Corporation, India and USA 
Inspiration stars

INSPIRATION

  • Angela Stokes, Vice President, Regulatory Affairs Services, Synteract, UK
  • Anne Dupraz-Poiseau, Chief Regulatory Officer, Orchard Therapeutics, UK
  • Francisca Paisana, Regulatory Team Leader, Roche, UK
  • Marguerite Prévotat, Senior Director, Global Regulatory Affairs, Rare Diseases, Ipsen Innovation, France 
Support image 

SUPPORT

  • Estelle Decarli, Associate Director Regulatory Affairs, BlueReg, France
  • PPD Regulatory Team working on specific BMS-Celgene Partnership activities, including Sharon Morton, Rina Kacha, Regina Eguiluz, Effi Giakouvakis and Inmaculada Moron, UK, Belgium and Spain
  • Regulatory Intelligence Policy & Advocacy Team (RIPA), led by Charity Schuller, PPD, Europe and USA 
  • The WAYS Pharmaceutical Services Team, led by Allison Steffen, USA

Winners, including the recipient of the Lifetime Achievement Award, will be announced at an online Awards Ceremony on 19 November 2020.