Hayley Hanvey, Pfizer
Hayley was nominated because of her hard work, commitment, negotiating and teamworking skills, and her exceptional ability to grasp new concepts.
Shilpa Jain, TRAC Services
Shilpa was nominated as she shows genuine passion and dedication to regulatory affairs. She has already used her skills to develop a technical induction package for new regulatory professionals in her company.
Winner of the 2011 Horizon Award was Hayley Hanvey
Kathleen Boyce, Janssen
Kathleen has shown her leadership during the introduction of a new documentation system to Janssen. Introduction of change, whilst still performing a normal regulatory function producing high quality submissions on time is challenging - but she managed it! As a result she was nominated to lead an end-user team to improve the system functionality across the EMEA region. She used her leadership, strategic thinking to drive the team for results and persisted in the face of adversity. In addition to her work on the documentation system, Kathleen has also worked on alignment of regulatory processes across four therapeutic areas in three geographic locations.
Luis Herrera Martinez, Center for Genetic Engineering and Biotechnology
Luis is one of the most important scientists and leaders in Cuban biotechnology. He is founder of the Center for Genetic Engineering and Biotechnology. His leadership by example has become an inspiration and guide for the more than 1000 workers in CIGB. Luis is a person much admired in the biotechnological field all over the world. He is member of several leading scientific academies, has received awards for his scientific achievements, is author of many publications, and several patents.
Helen Erwood, ESPL
In the last 10 years Helen has trained over 1,000 people. Helen’s love of training and her enthusiastic and inventive way of sharing her extensive regulatory knowledge make her a unique trainer. Her expert knowledge and experience has helped to make training courses enjoyable and effective. She has an ability to transfer knowledge to others in a clear and concise but more importantly humorous and therefore more memorable way. Fellow trainers say: ‘Helen’s enthusiasm for training is infectious.... Her knowledge base is astonishing and she is very happy to share it with everyone!’
Winner of the 2011 Inspiration Award was Luis Herrera Martinez
John Deavin, Deavin Associates
John was nominated for his creative adaptation of case studies from the MTRA MSc course into excellent published articles that explain concepts to a wider audience, including those with little or no knowledge in the devices field.
Stuart Finnie, Astra Zeneca
Stuart was nominated for his work in building up a Special Interest group on CMC issues in TOPRA and ensuring that the widest number of regulatory professionals were aware of and could participate in its activities.
Gillian Gauntlett, Consultant
Gillian addressed an urgent need to find a way to communicate the legal requirements for promotional and marketing materials for pharmaceutical products to marketing professionals in a clear and memorable manner. She developed a board game to do this.
Ann O'Connor, Irish Medicines Board
Ann was put forward for the highest level of communication skills demonstrated throughout her career, firstly as a hospital pharmacist, then as a senior manager in the pharmaceutical industry, in quality assurance, production, marketing and regulatory affairs, and since 1996 as a senior professional within the IMB.
Winner of the 2011 Communication Award was Ann O’Connor
Alison Bowers, Consultant
During her career Alison has utilised both her substantial and broad ranging regulatory experience and her extraordinary creativity to design, develop, deliver and evaluate numerous training solutions for a variety of in-house regulatory and clinical personnel and regulatory agency staff.
Ann O'Connor, Irish Medicines Board
When taking up an appointment with the Irish Medicines Board, Ann started an education programme with stakeholders in preparation for IMB assuming the role of a competent authority for devices.
Sandraq Shire, Arizona State University
As someone with seventeen years of experience in the regulatory field, Sandy worked closely with the FDA and the University to create a Regulatory Science Master’s degree with a balanced programme that has equal value for regulators as well as for the regulated industry
Siegfried Schmitt, Parexel
Siegfried has shown outstanding commitment to progressing regulatory harmonisation, pharmaceutical quality and compliance knowledge forward in a time of rapid product globalisation and healthcare cost constraints.
Winner of the 2011 Education Award was Alison Bowers
Idis provided much-needed support to source, navigate the uncertain regulatory environment and supply an unlicensed medicine to help save a baby’s life. Idis had to support and understand the requirements of the Great Ormond Street hospital, negotiate with the University in California, facilitate the required approvals from regulatory bodies in both USA and UK and overcome the logistics of importing an unlicensed drug from California into the UK within a critical timeframe.
Regulis showed their outstanding support for a new company for around 18 months, initially providing due diligence support for the company in its infancy and now supporting a much larger global company with its own regulatory department.
TRAC worked with a client to always deliver projects on-time creating a reliability and responsiveness that is earning them a growing reputation within the industry. TRAC have continuously delivered high quality output for this client and, also importantly, within the agreed budget.
Members of the product team have worked collaboratively with customers to re-shape their offering to develop one that was significantly more cost-effective. They overcame challenges of geography, language, culture and user type to develop this product which is used in regulatory intelligence.
Winner of the 2011 Support Award was Regulis
The winner of the 2011 Lifetime Achievement Award was Professor Stuart Walker
Our winner has given lifelong service to regulatory science and has had a seminal and profound influence on regulatory affairs.
Stuart founded the Centre for Medicines Research and built this to become arguably the premier group for benchmarking both research and development in the pharmaceutical industry and the regulatory process.
He is a Professor in the University of Cardiff and has supervised many PhD students who have undertaken research into the drug development process and especially into comparative regulatory affairs.
He founded the Institute of Regulatory Science which, under his leadership is recognised as a leading global source of information which has taken up a number of key matters. The first was the important topic of benchmarking, initially the performance and more recently the quality assurance of regulatory agencies. The latter has culminated in the development of a regulatory scorecard used between the agencies of Switzerland, Singapore, Canada and Australia. The former work was critical in the development of the European Regulatory system in the early ‘90s.
He was a proponent of mutual recognition and of identifying causes of disharmony. Inevitably, this led him to be a leader in ICH and for ten years he was one of the major figures in the international harmonisation arena.
Almost 25 years ago he identified the importance of determining benefit risk for medicines and has continued to promote and develop this theme. More recently he has proposed the elaboration of both qualitative and quantitative methodologies for determining benefit risk and through workshops (which continue) has led the debate between key regulatory agencies.
He was also one of the first to recognise the importance of harmonisation and support for the regulatory process within emerging markets and this particular strand of work within the Institute has generated major benefits.