K e e p i n g
y o u
T he T O P R A N ewsletter – K eepin g members in T o u ch
December 2013
Putting on the glitz! The Awards, Annual Lecture and Annual Review meeting are a chance for us to come together as a profession.
AWARDS EDITION The Fourth TOPRA Awards for Regulatory Excellence on 27 November at the Institute of Directors in London was a glittering celebration of the contribution of regulatory professionals to the drug and device development process. We’re delighted to share the individual and team successes of regulatory professionals in this special Awards InTouch edition.
Celebrating excellence in regulatory affairs is of utmost importance, not only to recognise and exemplify individual achievements, but also to raise the standard of our profession. This year’s Awards was preceded by the Annual Review meeting (see back page) and a thought-provoking lecture by Professor Sir Kent Woods, Chair of the EMA Management Board (see below). This gala dinner was a spectacular celebration showcasing inspiring successes and achievements. Nominations from all over the world had been assessed by an eminent judging panel, drawn from agencies, industry, law, academia and patient groups; not an easy task given the many nominations that were received in every category. It was an evening for meeting regulatory peers, colleagues and friends; enjoying the pleasant atmosphere and historic location; and for good food and a laugh or a smile. With this important celebratory event, my Presidency has almost come to an end. A great deal of hard work has been provided by TOPRA Office staff, Board members and volunteers during this year. All this hard work has led to many achievements supporting the Board’s longer term strategic plan, including progress in the area of developing new and modern high-quality online services, explorations of new strategic alliances and collaborations and providing an independent platform for debate. Although the pharmaceutical industry sector is still experiencing challenging times, we are focusing on the many new opportunities that the continuously changing world around us offers. TOPRA’s celebration of the 10th anniversary next year is an ideal time for a revitalising new start, looking ahead and to ensuring that we are ready for the next decade of TOPRA successes. I wish you all very happy seasonal holidays at the end of December and all the best for the New Year to come! Patrizia Nestby, President, TOPRA
second annual lecture
Professor Sir Kent Woods: Proportionate regulation This year, we welcomed another highly prestigious speaker from the regulatory world – Professor Sir Kent Woods, Chairman of the EMA Management Board and latterly Chief Executive of MHRA, who talked on ‘Innovation, regulation and the public health’.
In a personal reflection, he highlighted the interplay between these three aspects and demonstrated the ever-expanding role of the regulator and the ‘delicate duality’ of the work of a regulatory agency. He concluded that regulators have a role in supporting safe innovation but must be ever-vigilant in maintaining a
risk-based approach without over-burdening industry. He noted that all parties share an interest in ensuring novel products are brought to market for the benefit of public health and that regulation must be proportionate to do so. After the lecture, Sir Kent was thanked by Chair of the TOPRA STAR Panel, Alan Hunter, who presented Sir Kent with TOPRA’s highest accolade, Honorary Life Membership (see picture left).
For more information about the Awards go to www.regulatoryaffairsawards.org
K e e p i n g
y o u
regulatory colleagues
This year’s Awards were the biggest ever and are a testament to the growing success and recognition of the programme, according to the evening’s host Professor Trevor Jones at the glittering event in London’s Institute of Directors on 27 November. The Awards programme recognises the excellent contributions of regulatory professionals from across the board at all stages of their careers: from practitioners to educators and communicators; from innovators and service providers and a combination of all the above. ‘Once again the shortlisted nominees in this year’s Awards reflected the very best in the regulatory world,’ says Lynda Wight, TOPRA’s Executive Director. ‘The winners – from promising new regulatory professionals to those with a lifetime of regulatory service at the highest international level - are examples of real regulatory excellence and I congratulate them all. Our eminent judging panel, drawn from agencies, industry, law, academia and patient groups, had a challenging task to assess the excellent nominations we received in every category.’
celebrate Regulatory Excellence The winners of the fourth annual TOPRA Awards for Excellence in Regulatory Affairs were announced at a gala celebration in London on 27 November.
Horizon
Sarah Bentouati with Paul Bridges, Worldwide Head, PAREXEL.
HORIZON recognises relatively new regulatory professionals who have shown outstanding skill and promise. This year the Award, championed by PAREXEL, a global CRO, went to Sarah Bentouati whose ‘technical, team working and leadership skills are very impressive for someone who started working in regulatory so recently’. Sarah said ‘I would like to thank TOPRA for selecting me for the Horizon award and Heidi Clark for nominating me. I am very grateful for the support of my colleagues and mentors at Roche, which have helped me to continue to develop – I am honoured’.
Inspiration
Chris Griffett and Ridda Michail representing Regulatory Professionals.
INSPIRATION acknowledges senior regulatory professionals who lead and influence others in the profession. The winner, Chris Griffett, has inspired colleagues in a career spanning 30 years in companies including Celgene, Schering Plough and AstraZeneca. ‘I am truly honoured to receive the Inspiration Award, especially in the presence of so many who have inspired me so much. My thanks go to those colleagues who nominated me for this wonderful award, and to friends across TOPRA, a great group of professionals.’ he said after receiving his trophy from category sponsor, Regulatory Professionals.
Communication
Mauricha Marcussen received her Award from Elizabeth Madichie, Executive Director, PPD.
COMMUNICATION was awarded to the Auditgraph team, led by Mauricha Marcussen, who redesigned regional labelling processes and applied innovative technology to improve communications in a global biopharmaceutical company. ‘This award exemplifies the impact that our regulatory compliance technology has on stakeholder product labelling communication around the world,’ Mauricha said. PPD was delighted to sponsor this category again, said Elizabeth Madichie, Executive Director, Regulatory Affairs. ‘The calibre of the candidates shortlisted... is a true reflection of the quality of talented individuals and teams that represent our profession at a global level, thus making it extremely difficult for the judging panel to choose a worthy winner.’
Above: The Roche Team celebrating with TOPRA President-Elect Jonathan Trethowan.
Above: Diamond BioPharm received their Award from sponsors, Samarind.
Above: Judge Glenn Carpenter presented the Award to the Triskel Team.
Education
INNOVATION
Support
EDUCATION consistently receives the most entries each year. Out of a very strong field, the winner was the F Hoffmann - La Roche Regulatory Team, Basel, Switzerland. The team was recognised for establishing an industry leading, high-quality programme that allows regulatory trainees to develop in a nurtured environment. Mark Hope, Global Head of Neuroscience and CardiovascularMetabolism RA said it was ‘fantastic to receive this award in recognition of this graduate development programme’.
INNOVATION recognises ingenuity, creativity and innovation to improve outcomes for colleagues, clients and ultimately patients and it was sponsored for the third time by Samarind, a previous winner of this distinction. Miranda Pothiawala from Samarind presented the Award to Diamond BioPharm for its work on a gene therapy approval which was challenging on many fronts, as it was a unique product with a novel mechanism of action in treating an extremely rare disease. Team leader, Maureen Graham said later ‘We were over the moon winning the award for Innovation. It has taken pride of place on the front reception desk.’
SUPPORT acknowledges the crucial role that service providers play in the regulatory process. This year’s winner, the Triskel Team, clearly demonstrates a commitment to go the extra mile for clients, working round-theclock to meet challenging timelines. Aarti Naik, Senior Scientific Consultant, said ‘We are honoured to receive this prestigious award from TOPRA, the leading professional organisation in our field, in recognition of our work by our peers.’
Guests enjoy the opportunity to catch up with colleagues during the pre-Awards reception.
achievement – professor Kjell Strandberg This Award celebrates the career of an individual who has contributed a great deal to regulatory affairs, drug development and regulatory science. Professor Strandberg has devoted most of his 36-year professional career to improving the regulatory process. Recognising the need for high calibre in-house staff, he advanced the Medical Products Agency (MPA) in Sweden to become one of Europe’s most respected and frequently used agencies. He also served as the Chairman of the EFTA Pharmaceutical Committee which was responsible for achieving harmonisation of national pharmaceutical legislations compatible with the EEC, thus creating a platform for the new system for approval of marketing authorisation applications to be put in force in January 1995. Professor Strandberg is recently retired chair of the NDA Advisory Board. ‘To receive the TOPRA Lifetime Achievement Award 2013 brings both pride and joy to me,’ said Professor Strandberg. ‘Being recommended for the Award by a jury of distinguished colleagues representing important areas of the discipline means that my work over the years has been recognised as important in the development of regulatory science and its proper application on regulatory issues in the health care sector.’
Right: Kjell Strandberg was presented with his Award by Craig McCarthy, Chair of the Awards Working Party.
A u g u st 2 0 0 9
K e e p i n g
y o u
D ecember 2013
Congratulations to our graduates
Jenine Willis, Greer Deal and Ishbel MacDonald
The Awards evening began with a formal recognition of the students who have graduated with a TOPRA postgraduate qualification in the past year. Congratulations to them all!
Editorial support: Rachel Cook
How to contact InTouch InTouch welcomes contributions from TOPRA members. If you would like to contribute to the newsletter, or find out about deadlines, please contact Jenine Willis (jenine@topra.org). Above (L to R): David Smith, Anne Lenihan, who both achieved a distinction in their MSc RA, and Patrizia Nestby.
Above (L to R): Professor Sir Kent Woods with Christine Degeling, Alenka Drazumeric, Ursula Hopff and Siwan Thomas, who each obtained an MSc RA.
topra Annual Review meeting – 27 November 2013
Activities, finances and plans for 2014 The Annual Review Meeting is the place where TOPRA Board members review the organisation’s activities over the past year, present the financial outcome and share plans for the year ahead with members. This information is also contained in the Annual Report which is available at www. topra.org/sites/default/files/assets/img/ annual-report-12-13.pdf. An important part of the meeting is the announcement of the new Board following the keenly contested elections. The new Board from 1 January 2014 will be: PRESIDENT
Jonathan Trethowan
Past-President
Patrizia Nestby
President-Elect
Sarah Roberts
EU Representative Aine Kane North America Representative
Patricia Duchene
Director
Bob Clay
Director
Thomas Kuhler
Director
Carlos Langezaal
Director
Angela Stokes
Another pleasant duty at the Annual Review meeting is the presentation of awards to volunteers who have gone the extra mile in their support of TOPRA. The full list is given in the Annual Report, but Distinguished Service Awards were given to Craig McCarthy, Alan Hunter and John Deavin, who were present at the meeting (see photograph). Craig also accepted the TOP Team Award on behalf of the 2012 Symposium Working Party. TOPRA had planned to hold an extraordinary general meeting to vote on minor changes to the Articles of Association. These had been made available to members for some months on the website and only one query had been raised, which had been answered satisfactorily. No objections to the changes had been raised in advance of the meeting, but there were insufficient members available to formally vote these changes through.
Thank you to our Awards Sponsors! 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 Samarind who supported Innovation; Regulatory Professionals who supported Inspiration; PPD who backed Education and PAREXEL who supported the Horizon category. Thank you to them for making the evening possible and for showing their support for excellence in regulatory affairs.
samarind RMS
InTouch Editors:
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
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