Regulatory Affairs profession celebrates its achievements in style

Awards Dinner table

The winners of this year's TOPRA Awards for Excellence in Regulatory Affairs were announced at a gala celebration at London's Radisson Blu Portman Square on 28 November.

Richard Barker, OBE, who was recently named as one of the 50 most influential people in UK healthcare, hosted the event which attracted RA professionals from across Europe, the US and India and many healthcare sectors.

Welcoming the audience, Richard said, ‘These Awards are particularly pertinent now, as regulation is changing rapidly, and economic constraints and scientific advances put new pressures on medicines development.’

‘All the shortlisted nominees are to be congratulated in showing excellence in Regulatory Affairs. Our international list of winners from pharma, agency, CROs and independent consulting shows the breadth of regulatory skill and the important contribution it makes to the delivery of safe and effective medicines,’ said TOPRA’s Executive Director Lynda Wight. ‘Our eminent judging panel, drawn from agencies, industry, law, academia and patient groups, had a tough job to choose from the excellent nominations we received in every category.’

Awards and winners

Horizon - the award for individuals with fewer than three years’ experience in the regulatory profession, who have shown outstanding ability and promise went to Jenny Gray from Regulis Consulting.

Jenny joined the consultancy as an administrator but went on to qualify in health sciences in her own time through the Open University and moved into Regulatory Affairs in 2010.

Described by a client as ‘professional, prepared and precise in her planning,’ Jenny has certainly shown true potential.

Inspiration - recognising the contribution of those who inspire their fellow professionals and display excellence in leadership.

The winner in this category was Henrietta Ukwu from PPD, a global CRO.

Henrietta was described as ‘an extraordinarily effective leader and mentor throughout her career, identifying and developing talent, guiding regulatory professionals to successful careers and delivering impactful outcomes for the industry and patients in need’.

Innovation - honouring outstanding achievements in the deployment and successful implementation of innovative ideas, recognising those who truly embrace advanced ways to enhance the regulatory profession.

Gerald Thompson from The Boots Company was the winner in this category.

Gerald was nominated for what was described as ‘an outstanding case study in regulatory ingenuity’ by taking the requirements of the new children’s medicines legislation and creating a better presentation of a key children’s medicine. He used what could have been quite negative new legislation to very positive effect. The result was a massive uplift of sales of this medicine showing it was genuinely appreciated by mothers and pharmacists alike.

Communication – recognising the importance of clear and effective communication in regulatory affairs.

This year the award went to two people - Hilde Boone from EMA and Janice Soreth from US FDA for their roles in the liaison placement programme, which is an initiative designed to promote communication between the EMA and FDA, and their stakeholders.

Hilde and Janice have acted as overseas ambassadors for their home agencies. They have taken on the responsibilities of identifying, fostering and coordinating communication opportunities within these two key agencies. They have also committed to communicating their progress and current thinking through various channels, including industry events and professional meetings.

Education – recognising those who have made a significant contribution to the world of regulatory education and training.

Once again it was the best-supported category attracting the most nominations - a testament to the excellent work going on in regulatory education.

Frances Richmond was recognised in this category. She has been developing academic education programmes for regulatory professionals for more than 20 years. In 1999 she moved to the to the University of Southern California’s School of Pharmacy where she set up one of the first Masters in Regulatory Sciences programmes. Almost 10 years later, she developed the first Doctoral Programme in Regulatory Sciences in the world.

Support – recognising the crucial role the support sector plays in the effectiveness of the regulatory process and acknowledging the importance of the quality of the work they do.

The Award was accepted by Melanie Carr for the work of the SME Office at EMA.

Navigating the regulatory maze can be daunting, particularly for smaller companies, and the SME Office has shown great dedication and enthusiasm to being a single interface with almost 800 companies who now have designated SME status.

Life Time Achievement – the crowning glory of the Awards celebration, recognising the career of an individual who has done a great deal to further the cause of Regulatory Affairs, drug development and regulatory science over many years.

This award is judged by the entire judging panel. They had a very difficult job this year as nominations were received for some outstanding candidates, from consultancies, agencies and industry, nominated by some of the most eminent individuals in the regulatory world.

This year’s winner is a veterinary professional who started his career in 1966 - in the early days of regulatory affairs for veterinary products in Europe.

President of TOPRA, Dr Patrizia Nestby was delighted to present the award to Dr Bill Vandaele, who participated in the development of the first Directive in 1971, in the updated Directives between 1994 and 2009, and is still involved in the current review for 2013! He was a co-founder and past President of the Federation of Veterinarians in Industry and Research and of the Association of Veterinary Consultants. His key contribution to EU Regulatory Affairs for veterinary products was his input on orphan drugs resulting in specific EMA guidelines for reduced requirements for obtaining marketing authorisations in such cases.

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