TOPRA Awards for Regulatory Excellence 2016 winners

The 2016 TOPRA Awards for Regulatory Excellence took place on 2 November at the Grand Connaught Rooms in London. It was a fantastic night, with dinner, drinks, music and – most important of all – awards.

The judges had a real challenge on their hands picking the winners, as there were so many talented nominees in each category. In the end they decided on the following – congratulations to all of them, as well as everyone who was nominated!


Supporting regulatory professionals conveying complex healthcare messages to a broader audience.

WINNER: Anja Holm – formerly Chair of the Committee For Medicinal Products For Veterinary Use (CVMP), Denmark

What the judges said:

Anja Holm was recently interviewed for an article for Regulatory Rapporteur, giving responses which provided considerable insight into her role as chairman of the CVMP and the workings of the CVMP. This article really communicated how demanding the life of regulators can be, but also how important they are in ensuring that medicines for animals are suitably licensed.


Recognising experienced individual RA professionals who do an excellent job

WINNER: Eva Kopecna – Head of Global OTC Regulatory Affairs, Teva, Switzerland

What the judges said:

As well as her work supporting others, Eva completed her TOPRA MSc in 2008 with distinction and was awarded the prize for the best student in her year. She helped introduce regulatory affairs into the curriculum at the University of Brno and has received Czech government approval for the training of over 150 students. She has also just completed her PhD focusing on OTC medicines.


For educators and course leaders developing regulatory education.

WINNER: Roche EU Regulatory Trainee Programme – Roche, Switzerland

What the judges said:

The Trainee Community is led by Heidi Kern and Maria Grazia Zampori, previous Basel Trainee Coordinators; Sabrina Chernine and Xavier Prugnard, current Basel Trainee Coordinators; Lesley Narburgh, Louise Slater and Erin Brooks, from the Welwyn Graduate Trainee Scheme; and Michelle Rohrer and Natasha Jarrett, who sponsored the EU Regulatory Trainee Programme at Roche. As a result of their engagement, many trainees are now working as independent regulatory professionals and more new trainees are being recruited every year.


For recent entrants into the profession who have already shown great potential.

WINNER: Emily De Lay – Senior Regulatory Associate, Pfizer, UK

What the judges said:

Emily has the ability to manage her workload efficiently and effectively, taking thoughtful decisions and engaging with others on strategy and decision making. She is rapidly gaining experience in regulatory strategy and applying her expanding knowledge of rare diseases to excellent use in other disease areas. She is always open to new initiatives and is sensitive to changing personal demands and requirements.


Recognising the achievements of those who have significantly improved the regulatory process.

WINNER: Max Kanevsky and Pinnacle 21 LLC – US

What the judges said:

Pinnacle 21’s industry-leading software has become a game changer for clinical data validation and submission readiness, enabling sponsors to quickly and efficiently review and validate conformance. Simultaneously, it has also streamlined the FDA’s process for accepting and validating the datasets. In 2011 the commercial version of Pinnacle 21 Community was created, now known as Pinnacle 21 Enterprise, which has been used by sponsors around the globe. In 2015, the US FDA and Japanese PMDA formally contracted with Pinnacle 21, to use Pinnacle 21 Enterprise.


Acknowledging senior professionals who inspire and mentor others

WINNER: Dianne Lee – Director, DLRC Ltd, UK

What the judges said:

Dianne is an inspiration as a Regulatory Professional with her extensive knowledge and decades of experience across the whole product lifecycle. During the last 10 years she has set up and continues to lead a successful and growing business; one which nurtures new graduates and veterans alike. Under Dianne’s direction the company has offered paid internships, employed students for work experience and has recruited, trained and provided ongoing mentoring for several new graduates.


For service providers and consultants who go the extra mile for their clients.

WINNERS: Mel Munro and Rhona Banks – Regulatory Consultants, Triveritas (and RA-Elect), UK

What the judges said:

A specialist veterinary consultancy, this team achieved ultimate success when their work for their client was approved by CVMP in spring 2016 – the first recombinant chimeric protein vaccine in the EU. This achievement was due to the long successful working partnership between the client and our winners!


Acknowledging the role of regulatory science in bringing innovative technologies and medicines to the clinic.

WINNER: Stephen Liggett – Research Governance Manager, Queen’s University Belfast, UK

What the judges said:

The positive responsive of stakeholders and the interest generated in incorporating regulatory affairs into early stage research has established Stephen as a leader whose advice is highly regarded by the wider academic community. A cell therapy product will soon be in phase 1 clinical trial after securing Translational funding from the Wellcome Trust. The MHRA has endorsed this early engagement with the university and plan to publish a case study at the end of the month citing the pilot as an example of best practice.

Lifetime Achievement Award

WINNER: Daniel Brasseur

What the judges said:

Daniel is a paediatrician who has dedicated his whole career to championing improvements in the health and well-being of children. He is a courteous and committed colleague and thoroughly deserving of this award.

Daniel receives his award