K e e p i n g
y o u
T h e T O P R A N e w s l e tt e r – K e e p i n g m e m b e r s i n T o u c h
Decem ber 2012
Celebrating in style!
AWARDS EDITION The TOPRA Awards for Regulatory Excellence were established in 2010 to celebrate and promote the role played by regulatory professionals in the drug and device development process. Until this time there were no Awards that drew attention to the vital role Regulatory Affairs plays in delivering medicines and devices to the marketplace. We’re delighted to share the individual and team successes of Regulatory Affairs professionals in this year’s Awards InTouch edition.
As a successful year comes to a close, the Awards and Annual Lecture provide the opportunity to reflect on achievements and the way ahead
‘As your new President it was a real pleasure and honour to be at the recent Annual Lecture and Awards evening and to present the Lifetime Achievement Award to our worthy winner. This evening showcased the rich diversity of our profession and the exciting direction in which it is moving – which is what makes it so interesting and so challenging to work in. ‘It was good to see many members of the independent judging panel at the Awards to see the fruits of their confidential deliberations and to celebrate with the winners from agency, industry and academia. In this way TOPRA is succeeding in its aims of promoting the regulatory profession and the raising of standards within it. ‘I look forward to my term as President and my part in continuing these aims.’ Patrizia Nestby, President, TOPRA
The TOPRA Awards highlight the great contribution, the dynamism and the commitment individuals have made to advancing the Regulatory Affairs profession and public health. It is wonderful to be able to recognise individuals for their tireless work and to note that at the end we are all seeking to help patients. Our activites this year have been a great success, particularly the Symposium in Dublin. Suffice it to say that TOPRA is in very good health and has brought forward a range of initiatives to help support and advance the regulatory profession. We cannot be complacent. The life science sector is going through a period of very profound change. The landscape will look significantly different in five years’ time. It is arguable that product development and the regulation of life science products has changed relatively
little over the past 40 years. New initiatives and new scientific developments have been retrofitted into the existing paradigm. I’m not sure this can continue; progressive and radical thinking is required. A combination of scientific changes, technological developments alongside new societal expectations and methods of communication, mean that much of what we do now may no longer be appropriate. These were the very themes that Sir Michael Rawlins considered in the inaugural TOPRA Annual Lecture which took place before the Awards.
Sir Michael’s stimulating and challenging views on the future of medicines regulation are covered in more detail later in this edition (see back page). Many will see this as a threatening period. I prefer to see this as a great opportunity. I am sure that TOPRA will respond to these opportunities and is in a great position to support the profession. I know that the organisation is in very good hands as Patrizia, President, and Jonathan Trethowan, President Elect, take up their posts. I wish them very great success. David Jefferys, Past President
For more information about the Awards go to www.regulatoryaffairsawards.org
K e e p i n g
y o u
T he TOP R A N e w s le tt e r – K e e p in g m e m b e r s i n To u c h
profession unites to Celebrate Regulatory Excellence The winners of this year’s TOPRA Awards for Excellence in Regulatory Affairs were announced at a gala celebration in London at the Radisson Blu Portman Square on 28 November.
THE WINNERS Horizon
The HORIZON Award is open to an individual with fewer than three years’ experience in a Regulatory Affairs role. Nominees must have shown outstanding ability and promise. This year the honour went to Jenny Gray from Regulis Consulting. Jenny joined the consultancy as an administrator but then went on to to qualify in health sciences in her own time through the Open University and moved into Regulatory Affairs in 2010.
Our host for the Awards Ceremony this year was Richard Barker, OBE, who was recently named as one of the 50 most influential people in UK healthcare. The evening 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,’ said TOPRA’s Executive Director Lynda Wight .‘Our eminent independent judging panel, who are drawn from agencies, industry, law, academia and patient groups, were called on to evaluate the excellent nominations we received in every category.
Inspiration The INSPIRATION Award recognises the contribution of those who inspire their fellow professionals and display excellence in leadership. Henrietta Ukwu from PPD, a global CRO, was announced the winner. She 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’.
Communication
Top–bottom: Jenny Gray with judge Chris Griffet; Henrietta Ukwu from PPD; Hilde Boone from EMA and Janice Soreth from US FDA.
The COMMUNICATION Award recognises the importance of clear and effective communication in Regulatory Affairs. Hilde Boone from EMA and Janice Soreth from US FDA were recognised in this category for their roles in the liaison placement programme. This innovative initiative has promoted 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 The EDUCATION Award recognises 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 is going on in regulatory education. The winner this year was Frances Richmond, who has been developing academic education programmes for regulatory professionals for more than 20 years. In 1999 she moved 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.
INNOVATION The INNOVATION Award honours 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 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.
Support
Top–bottom: Frances Richmond; Gerald Thompson and Miranda Pothiawala, Samarind; Constantinos Ziogas, Melanie Carr with judge Mary Baker.
The SUPPORT Award acknowledges the crucial role the support sector plays in the effectiveness of the regulatory process and acknowledges the importance of the quality of the work they do. The Award was presented to Melanie Carr and Constantinos Ziogas 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 highlight of the Awards Ceremony is the Life Time Achievement Award, which is assessed by the entire judging panel.
A delighted Bill Vandaele receives his Achievement Award from TOPRA President Patrizia Nestby.
This Award celebrates 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. The judging panel 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. TOPRA President, 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. Accepting the Award, Bill said he was surprised to have won, but was very honoured and proud to have been nominated A u g u s tfor2the 009 Award by colleagues and peers in the veterinary world.
K e e p i n g
y o u
D ecem ber 2012
InTouch Editors: Jenine Willis, Greer Deal and Virginia Guellal
How to contact InTouch InTouch welcomes contributions from TOPRA members.
TOPRA has established an excellent reputation in regulatory education in large part due to the MSc courses we run. The Awards guests joined TOPRA in congratulating those who have completed their studies as part of the TOPRA MSc in Regulatory Affairs. All studied for their qualifications while holding down responsible and often challenging jobs. Pictured above from left to right between Sir Michael Rawlings and David Jefferys are: Stella Koukaki and Claire Baynham (MSc in Regulatory Affairs); Laura Saunders and Monica MacGregor (Postgraduate Diploma with Distinction in Regulatory Affairs); and Eleanor Davies (Postgraduate Certificate in Regulatory Affairs).
Inaugural TOPRA Annual Lecture Sir michael Rawlins: adaptation is vital The first TOPRA Annual Lecture took place before the TOPRA Awards Dinner. Speaking to a packed audience of healthcare Regulatory Affairs professionals from industry, consultancy, agency and patients’ groups, Sir Michael Rawlins addressed the question ’Is the regulatory profession fit for the future?’ to which he answered he didn’t know, but that that the profession would need to adapt to the rapidly changing regulatory environment and respond to healthcare innovation. The audience had no need to be disappointed by Sir Michael’s opening response to the question as he clearly set out the challenges which the pharmaceutical industry will face over the next decade. He then put the challenges into the historical context of the debate within science between the deductive approach, which tests a theory, and the inductive approach, which tests a pattern identified by observation. This set the groundwork for his message that regulators and industry have to re-evaluate how they test and use clinical data to support decisions on marketing authorisations and benefit-risk decisions. Sir Michael argued for a major reappraisal of the hierarchy of evidence and the need for flexibility to use observational data, historical control studies and to introduce real-world studies . He also stressed the opportunities offered by the use of Bayesian statistics and the need for pilot projects to take forward adaptive licensing. He concluded by stressing the need and the opportunity for the regulatory science profession to seize and lead the debate – a challenge that the audience seemed willing to take on. Thanking Sir Michael for his insightful lecture, Dr David Jefferys, Past President of TOPRA, said the lecture was ’a timely wake up call for all engaged in medicines regulation that the profession would take forward’. Each year, the Annual Lecture will offer regulatory professionals an opportunity to hear a worldclass authority reflect on the current environment for the regulatory profession and give their predictions for the future. Although the lecturers will present a personal perspective, they will offer an important ‘horizon scan’ to give attendees an insight into the challenges faced by the profession.
If you would like to contribute to the newsletter, or find out about deadlines, please contact Jenine Willis (jenine@topra.org). Please address any articles and correspondence to: intouch@topra.org or submit your contribution via www.topra.org/intouch Views expressed in InTouch are those of the contributors and not necessarily those of the editors or TOPRA. While every effort is made to ensure information is accurate, conditions may change and readers are advised to consult current official texts and/or to seek appropriate professional advice before taking any regulatory action. © 2012 The Organisation for Professionals in Regulatory Affairs
TOPRA Bellerive House 3 Muirfield Crescent London E14 9SZ Tel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 E-mail: topra@topra.org InTouch is free to TOPRA members. Annual membership of TOPRA is €225. TOPRA members can read or download InTouch online at www.topra.org
A warm thank you to our Awards Sponsors this year! The Awards for Regulatory Excellence are presented each year by TOPRA as a way of celebrating all that is best across the Regulatory Affairs and regulatory science world. Entries are encouraged from anyone involved in the regulatory process – whether TOPRA members or not. The Awards are judged and the winners selected, not by TOPRA, but by an independent panel of experts who come from agencies, industry, academia, patient groups and the legal profession. TOPRA arranges the Awards event to enable the shortlisted nominees and eventual winners to receive the recognition and congratulations they deserve. TOPRA is grateful to our sponsors for the support given for the event – without them the celebration could not take place. This year our sponsors were Thomson Reuters, PPD and Samarind. Thank you to them for making the evening possible and for showing their support for excellence in Regulatory Affairs.
samarind RMS
TOPRA is the registered trademark of the The Organisation for Professionals in Regulatory Affairs Ltd, registered community trademark number 003182961. The TOPRA logo is covered by the Community Design Registration Numbers EU Des Reg no. 000055553-0001 and 0002.
www.topra.org/intouch