University innovation celebrated as short-lists are announced for 2010 Regulatory Affairs Awards

The Organisation for Professionals in Regulatory Affairs (TOPRA) is pleased to include the University of Leeds among its short-listed candidates for the 2010 Regulatory Affairs Awards. The Awards are the first in Europe to celebrate the achievements of professionals involved in the regulation of the healthcare industry. Candidates selected for this year’s short-lists reflect the diversity of individuals and organisations that contribute to the development and delivery of safe, effective medical therapies.

After an excellent response to the call for nominations and rigorous examination by an eminent panel of judges, short-lists have been produced for four different Award categories: Innovation, Inspiration, Support and Horizon. Alongside four other short-listed candidates in the Innovation category, the University of Leeds was recognised for its contribution to Regulatory Affairs. A member of the Russell Group, the University is noted for innovative research schemes in the biomedical sciences. This nomination specifically recognises the work of DK Raynor, Professor of Pharmacy Practice at the University, and Dr Peter Knapp, who have pioneered new ways of user-testing the readability of information supplied to patients in clinical trials. Judges recognised that their novel approach improves the safety and efficiency of trials, ultimately helping to speed-up the delivery of new therapies to the healthcare market.

Winners of all short-listed categories, and an additional Lifetime Achievement Award, will be announced during a gala dinner and Awards ceremony at the TOPRA Annual Symposium on Tuesday, 5 October 2010, at London’s Hilton, Park Lane.

www.regulatoryaffairsawards.org for full details

Short-listed candidates

INNOVATION category

University of Leeds – A member of the Russell Group, the University is noted for pioneering innovative research schemes in biomedical sciences. The nomination specifically recognises an innovative approach for user-testing the readability of information supplied to patients in clinical trials.

Farenta Oy, Finland – Founded in 2003, Farenta Oy support the entire operational chain of pharmacy and pharmaceutical management for companies in Finland. They developed Emergency Channel, which is an innovative method of informing pharmacies about important changes to medicines on the Finnish market.

Pfizer, Packaging Redesign – A leading global pharmaceutical company at the cutting edge of research and development in medicines for humans and animals. Their redesign projects used packaging colours and artwork to differentiate products and strengths of all Pfizer prescription medicines in the UK and Ireland with the aim of improving patient safety.

Samarind RMS On Demand – A tracking database and electronic document management system, which is available to pharmaceutical licence holders and regulatory consultants anywhere in the world via the internet.

PPD Results Development – Leading global contract research organisation, applying an innovative approach to drug discovery, development and lifecycle management services. Their web-based application RESULT (Regulatory and Ethics SUbmission and pLanning Tool) supports comprehensive planning, tracking and management of initial CTA submissions, amendments and end-of-trial activities.

SUPPORT

Octagon Research Solutions – A leader in the electronic transformation of Research and Development, offering regulatory, process and IT solutions to the life sciences industry.

DLRC Ltd – Established in 2005, DLRC offers regulatory consultancy service to clients and covers the whole spectrum of regulatory activities.

Regulatory Resources Group (RRG Ltd) Consultancy team – The RRG Consultancy team has a breadth of regulatory knowledge which they can apply quickly in challenging situations to support clients. The company provides a range of strategic, managerial support and training to clients throughout the life cycle of product development and marketing.

Pharmalink Consulting – A network of more than 2000 professionals worldwide providing a suite of Regulatory Affairs services to product developers and manufacturers at local and global scales. Their expertise enables companies to achieve milestones within tight deadlines during times of increased workload.

INSPIRATION

Ivan Fisher, Pharmalink Consulting – Ivan Fisher is the Regulatory Affairs Manager at Pharmalink Consulting. Ivan has demonstrated a passion for developing the skills of people who work within his Regulatory Affairs team, with a particular focus on those individuals who are at the beginning of their careers.

Linda Woods, UKR Regulatory Affairs – Linda Woods co-founded UKR in 2001 to handle UK aspects of International Regulatory Affairs projects. She has inspired her team by taking a positive attitude to challenges, as well being a source of detailed knowledge on processes and legislation.

Jonathan Trethowan, TRAC Services Ltd – Jonathan Trethowan is the managing director of TRAC Services Ltd, providing off-site Regulatory Affairs services using a highly successful outsourcing model. Jonathan has developed an excellent training programme for new recruits to ensure their career development.

Michelle Gafa, Actavis, Malta – Michelle Gafa is the Regulatory Affairs Department manager at the Research and Development division of Actavis Ltd, Malta. Michelle is an example to her team, providing encouragement on a day-to-day basis and in their career development. Actavis in Malta has become a key contributor to the output of generic pharmaceuticals for the Actavis parent company.

HORIZON

Celebrating the brightest and best of today’s young regulatory professionals, the judges have decided the short-list for this award will be:

Sakshi Chabra, Pfizer
Edgar Harvat, Proctor & Gamble
Samantha Lawson, Proctor & Gamble

ACHIEVEMENT

A winner will be selected from five excellent candidates and will be announced at the Awards.

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