2012
HORIZON
Shortlist
Jenny Gray, Regulis Consulting
Jenny joined Regulis in 2004 as office administrator with no previous pharmaceutical experience. In 2010, she was given the opportunity to prepare a number of Type 1A variations – something she did successfully with enthusiasm, diligence and good attention to detail. Jenny took the decision to study in her own time for an Open University qualification in health sciences. At the end of 2010, Jenny was formally appointed to the position of registration officer. She has successfully handled a diverse range of regulatory projects with minimal supervision. She clearly demonstrated excellent attention to detail, a good understanding of technical issues and excellent communication skills.
Sheetal Mudda, Microlabs
Although Sheetal has less than 4 years of experience in regulatory affairs in the pharmaceutical industry, she is now involved in the business development arena. She has shown the ability to perform in a stressful environment delivering great results despite heavy workload and stringent deadlines. Described as a good team player with the will to see projects are delivered on time and with a good quality, she takes the initiative and motivates colleagues. Thus she shows great leadership potential. She is efficient in solving complex issues, a quick learner, enthusiastic and has a constant thirst for knowledge.
Eileen Ryan, Acorn Consulting
Eileen was born in New York and worked as an office manager in the Hackensack University Medical Center for ten years. She moved to Ireland in 2007, joining Acorn Regulatory as an Administrator. During late 2011, she was asked to manage all electronic submissions within the company. She has taken ownership for validating and publishing all electronic applications achieving a 100 per cent success rate at validation. She has engaged with the Irish Medicines Board and other National Competent Authorities in the pilot phase of the new Common European Submission Portal system. More recently, Eileen has designed and successfully held training events in electronic submissions with several Irish Pharmaceutical companies, as a means of helping them understand and prepare ‘NeeS’ and eCTD applications.
The winner of the 2012 Horizon Award was Jenny Gray
INSPIRATION
Shortlist
Gemma Robinson, Acorn Consulting
Gemma joined Acorn Consulting in Ireland in 2002 and provides regulatory consulting to pharmaceutical and medical device companies across Europe. Gemma has been quick to embrace technological changes in the industry, such as eCTD. Her impact on best practices in the industry is a significant one. She serves as Regulatory and Scientific Advisor to the Association of Pharmaceutical Manufacturers of Ireland and frequently liaises with the Irish Medicines Board, aiming to improve and support the local regulatory environment.
Joanna Schmidt, Abbott
Joanna was nominated for being a ‘wonderful leader’. She has worked for many years for Abbott and has dedicated her career to doing her best for that company and the patients who receive their medicines. Her nomination outlined the many ways in which she has supported and trained her staff, encouraging them to identify their skills and bringing out the best in them – helping them to make good careers for themselves. She has overcome personal adversity to succeed in her career. She is now head of the regulatory affairs department in Abbott Germany.
Henrietta Ukwu, PPD
Henrietta is an industry leader who has helped to redefine the role of regulatory affairs as an interactive, intellectual, strategic company resource helping significant public health goals to be achieved. Her published works include ‘The Role of Regulatory Scientist’ and ‘Blueprint – Driving Regulatory Excellence’. She is a pioneer professor of Temple University’s Quality Assurance & Regulatory Affairs graduate programme. She has received numerous recognitions for her contributions to medicine, science and the pharmaceutical industry, including Fellowships of the Regulatory Affairs Professional Society and of the American College of Physicians. In 2011 she was named in the PharmaVoice 100 list of most inspiring industry leaders.
The winner of the 2012 Inspiration Award was Henrietta Ukwu
INNOVATION
Shortlist
Alan Colley and Alex Yates, Amgen
Alan and Alex were nominated for their support of the adoption of the Voluntary Harmonization Procedure for clinical trials within Amgen. As a new process this has required some dedicated effort to raise awareness and to educate a number of functions on the potential benefits of adopting its use. They both also authored a published peer-reviewed article to share their experience and encourage others to use the procedure.
Mike May, TRAC Services
Mike was nominated for this Award by his client GlaxoSmithKline. Mike was responsible for identifying that the company’s document management system was not operating effectively. Mike’s contributions and feedback on the DMS directly resulted in the implementation of an effective business system support structure which was introduced in the first quarter of 2011. This had a wide and positive impact on the users, system support roles, and system functionality.
Gerald Thompson, Boots Company
Gerald was nominated for what was described as ‘an outstanding case study in regulatory ingenuity’ and a terrific partnership with product development, manufacturing and marketing. Gerald took the requirements of the new children’s medicines legislation and coupled this with a new idea for a better presentation of a key children’s medicine. This allowed the company to have a differentiated product on the shelf on time for the same year’s winter meds campaign.
The winner of the 2012 Innovation Award was Gerald Thompson
COMMUNICATION
Shortlist
Hilde Boone, EMA and Janice Soreth, FDA
Hilde and Janice were nominated in their roles in the liaison placement programme. This is an innovative 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.
The regulatory team, TRAC Services
The team were nominated by the marketing department for their input and commitment to the marketing strategy for regulatory services. Commitments to client confidentiality limit the use of conventional methods of marketing and so the team had to take a creative approach: they produced items for a newsletter, in-depth features and white papers and guidance documents for the website. They created their own schedule and worked to strict deadlines to produce material, in addition to their day to day regulatory roles.
Kim Wharton, Regulis Consulting
One of Kim’s clients submitted this nomination in respect of some excellent SmPC wording and a Clinical Overview. The task was to propose revised indication wording for an already approved SmPC to gain pan-EU regulatory approval without the need for new clinical studies. The application was approved without any changes being required, largely due to the quality of the writing and the clarity of the communication. The comments in the Final Variation Assessment Report indicated that the purpose of the variation had been clearly understood.
The winners of the 2012 Communication Award were Hilde Boone and Janice Soreth
EDUCATION
Shortlist
Sue Harris, MHRA
Sue has contributed to the TOPRA Spring Introductory Course, training new regulatory professionals, in a voluntary capacity, for over 11 years. Consequently she has helped train hundreds of new regulatory professionals. Sue is an excellent presenter; her enthusiasm, ability to discuss complex regulatory procedures at a suitable level, and in a humorous way make her unique. Sue also acts as a case study helper, providing an invaluable opportunity for new regulatory professionals to interact with an experienced Agency assessor. The feedback from the delegates on the content and delivery of her presentations is exceptional.
Francis Richmond, University Of Southern California
Francis was nominated by a US colleague. Frances has been an innovator in the development of academic education programs for regulatory professionals for over twenty years. In 1999 she moved to the to the University of Southern California’s School of Pharmacy where she developed, from scratch, one of the first Masters in Regulatory Sciences programs. In 2008 Frances developed the first Doctoral Program in Regulatory Sciences in the world.
Nancy Smerkanich, Octagon Research Solutions
Nancy developed and conducted internal regulatory training programs on introductory and advanced topics. She volunteers to produce and conduct training for industry and academic associations, and she guides her clients through the global regulatory landscape with warmth and wisdom. She has instructed thousands of people from 75 different companies, universities and industry organisations in Europe, USA and Asia. In her 30 years in industry, she has adapted her educational content to be delivered in person, in audio conferences, over the web and via e-learning programs.
The winner of the 2012 Education Award was Frances Richmond
SUPPORT
Shortlist
The SME Office at EMA, led by Melanie Carr
Navigating the regulatory maze can be daunting, and particularly for smaller companies. In their work at the SME office, Melanie Carr and her staff have shown great dedication and enthusiasm to being a single interface: facilitating communication, advising on regulatory issues and providing assistance with translations. They also organise workshops and training sessions. As of June 2012, 796 companies were assigned SME status and many of them have benefited from the support of Melanie and the team at the SME office.
Samarind
Fresenius-Kabi is a world leader in IV drugs, and like all large pharmaceutical companies, found the management of its product licences increasingly burdensome. They chose Samarind for their fit-for-purpose solution, both operationally and technically - but also because they embraced the concept that Fresenius-Kabi were looking for a business partner relationship and not simply a supplier. As a result Samarind provided a compliant xEVMPD solution well ahead of the July 2012 deadline, working closely with Kabi in a truly collaborative way.
Amy Whyte, Regulis Consulting
Regulis has provided a consistently high quality regulatory consultancy service to Nycomed who nominated her. Nycomed was recently acquired by Takeda and the integration process has been lengthy and complicated. Amy has been on top of all the relevant regulatory information throughout the process and has been immensely helpful in a very complicated integration process. She also assisted with a pharmacovigilance inspection and also several regulatory issues thrown up by historical handling of products.
The winner of the 2012 Support Award was The SME Office at EMA
LIFETIME ACHIEVEMENT
The winner of the 2012 Lifetime Achievement Award was Dr. Bill Vandaele
Our winner is a veterinary professional, with a career spanning 45 years in regulatory affairs for Veterinary Medicinal Products and Feed Additives.
He started his career in 1966 - the early days of regulatory affairs for veterinary products in Europe. As an industry representative he 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 also one of the first to cover Environmental Risk assessment of Animal Production - a new and now very relevant, topic.
His key contribution to EU regulatory affairs for veterinary products was his input on orphan drugs. In 1997 he initiated a working party at (the then) EMEA to identify reduced requirements for products in limited markets (the so-called M.U.M.S. - Minor Uses Minor Species). This resulted in a report from the Heads of Medicines Agencies in 2007 which finally resulted in specific EMA guidelines for reduced requirements for obtaining marketing authorisation in such cases.
He was the co-founder and past president of the Federation of Veterinarians in Industry and Research and the Association of Veterinary Consultants.
As a consequence of his work he was nominated as an honorary member of the European Association of Veterinary Pharmacology and Toxicology.