2011 Regulatory Affairs Awards: Back for a second year with two new categories

Nominations opened in March 2011 for seven awards, building on the success of the first ever Regulatory Affairs Awards held in 2010. Launched by The Organisation for Professionals in Regulatory Affairs (TOPRA) they pay tribute to those who significantly contribute to the delivery of safe and effective medical therapies to the market place.

Lynda Wight, Executive Director, TOPRA says, “These awards recognise excellence in regulatory affairs in the healthcare sector. Celebrating all that is best about the regulatory profession and the people in it. Building on from the success of our 2010 awards we are pleased to announce that the awards have been expanded to include two additional categories - Communication and Education.”

Last year’s winners were from pharma companies, consultancies and agency, thus representing professionals from every area of the regulatory community.

Miranda Pothiawala, Software Director at Samarind, said that, “Winning the inaugural TOPRA Innovation award in 2010 was a fantastic achievement, which gave us immense pride and satisfaction. Samarind’s profile has been raised significantly as a result of winning the award. It’s so important to the industry that regulatory professionals are being recognized and we encourage others to continue to celebrate talent, success and achievements by nominating colleagues, clients, and others in regulatory affairs.”

With two new categories, the seven different award categories ensure that people in all stages of their career and within all sectors of the healthcare regulatory industry to receive recognition. Categories now include: Achievement, Communication, Education, Horizon, Innovation, Inspiration and Support.

The event is continuing to be supported by an eminent panel of judges from government relations, industry, the legal profession and academia. It will culminate in a gala dinner and ceremony at the Four Seasons Hotel, Canary Wharf on 24 November 2011, establishing itself as a high point in the regulatory calendar.

-ENDS-

Notes to editor

The Organisation for Professionals in Regulator Affairs (TOPRA) is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

Awards Categories

ACHIEVEMENT
The judges will look for an individual who, throughout their career, has gone that extra mile and demonstrated a significant and lasting contribution to their work and/or the development of regulatory affairs as a profession. The nominee for the Achievement Award can be retired or semi-retired yet still active in a regulatory capacity.

COMMUNICATION
This Award recognises Regulatory professionals who have worked (perhaps together with other organisations) to ensure the delivery of safe and effective human or veterinary medicines or devices to market, through the exchange of ideas, or interaction using innovative communication solutions. The category also includes examples of good public health communication by Regulatory professionals relating to human or veterinary medicines or devices, or dissemination of information (such as a journal publication or a web-based article) on a technical Regulatory topic.

EDUCATION
This Award recognises an individual who has made a significant contribution to the world of regulatory education and training perhaps through the development of a formal educational qualification, the consistent delivery of a training product or perhaps the production of an innovative in-house training programme. The category also includes companies or organisations that have demonstrated support for the professional development of RA professionals through, for example, tailored training programmes, or encouraging staff to undertake professional qualifications, such as an MSc, etc.

HORIZON
Open to individuals with less than three years’ experience in the regulatory profession, this award recognises an outstanding ability in an individual. The winner will have set themselves apart from their colleagues with their accomplishments, leadership skills, motivation and commitment to regulatory affairs. Nominations are accepted from employers or managers, who should include details of the nominee’s abilities and potential.

INNOVATION
Every day in regulatory affairs innovation is taking place – new ideas for efficiency, new methods for productivity and new processes. The Innovation Award recognises that innovation is a key differentiator; it is a measure of the regulatory profession’s ability to adjust to the healthcare market and patient needs. Open to individuals, teams and organisations.

INSPIRATION
Aimed at a person who inspires the intellect or prompts action or invention, this award recognises exceptional contributions by an individual in inspiring fellow regulatory professionals in the development of their regulatory career, or as an inspirational team leader. The nomination should be submitted by an individual or team with personal experience of the professional inspirational accomplishments of the nominee.

SUPPORT
This award is in recognition of the critical role that supporting organisations play in the drug development process and the full life cycle of a medicinal product or device. Nominees might include database suppliers, training organisations, translation agencies, courier companies, agency project managers or regulatory consultancies of any size. The nomination should be submitted by an individual or a team with personal experience of the services provided in the past 18 months.