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THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH
In this issue In the regulatory profession we’re always making reference to the lifecycle of a project. Well in this InTouch we see the lifecycle of nature with the death of a highly valued TOPRA member, Linda Woods, next to the birth of Emma McNeely’s baby (see back page). Collaborations, education and teamwork are themes running through this issue, starting with David’s editorial (right); followed by the expanding ‘TOPRA In’ initiative and the Awards programme which recognises the successes of those committed to them (page 2). What’s so great about TOPRA is that it isn’t an exclusive organisation. A good example of this is the MSc modules, which are available to both students and short course delegates (page 3). Finally, the TOPRA lifecycle continues as some very long-standing members of the Advisory Council step down and four new members join (page 3). Greer Deal, Co-Editor
Helping shape future healthcare A message from David Jefferys, TOPRA President Four meetings I attended recently brought home the diversity and importance of regulatory science. They also illustrate the major role the regulatory profession has in shaping the future of the pharmaceutical and life science sectors. The first meeting was the 50th Anniversary celebration of the founding of the European Organisation for Research and Treatment in Cancer (EORTC). I attended this on behalf of Eisai, and was impressed by the advances that have occurred in cancer research, particularly in bringing molecular biology to the patient. In many areas we can now envisage cancer as a chronic disease. We are beginning to realise the benefits of adaptive trial designs, new paradigms for developing drugs and the regulatory approval along with the need to capture real-life data, patient preferences and quality of life information. These are all developments in which the regulatory profession should be significantly engaged. The next was a workshop on ‘The Red Tape Challenge’ where I represented the British pharmaceutical industry association (ABPI). This initiative is driven by the UK Government to identify, to scrutinise and, where possible, remove or simplify unnecessary regulation. Again it is good to see how the profession has responded in bringing forward issues and is working with the MHRA and other stakeholders to try to
improve the environment in which we operate. This is not only a UK initiative, as part of the work is to identify European matters where the UK can take a lead in simplifying guidance and regulations – literally lifting the burden from innovative industries. Science of drug safety Third was a two-day workshop organised by the EMA to consider medicines in the elderly. I joined this meeting as part of the new EFPIA Working Party on Geriatric Medicines. All the presentations are available on the EMA website and I recommend you take a look at the content. The discussions covered the science of ageing such as sarcopenia, the biological mechanisms causing frailty in the elderly, the requirement for real-world data and how to gain information on the handling of medicines in the extreme elderly. Consideration was also given to better use of pharmacovigilance techniques for capturing safety information, studying compliance and the formulation of medicines for older patients. Given that this is the decade for
healthy ageing, we can expect to see much more on this topic. Again the regulatory profession needs to be playing its part in this. The final meeting was on paediatric networks in Europe, which was organised by TOPRA and EMA/PDCO. This meeting enabled the paediatric community and the Enpr-EMA network to share experiences. As TOPRA President I was pleased to introduce this meeting, which also illustrated the role that regulatory professionals can play. We are all aware of the many challenges posed by the paediatric legislation and it is essential that research networks are created to help industry provide the clinical research platforms to bring medicines more rapidly to children. On another note, it is encouraging to see that members are reading these editorials. Several of you liked the book recommendations, so this month I’m suggesting a book mentioned at the EORTC meeting. It is Cancer on Trial by Peter Keating and Alberto Cambrosio, published by the University of Chicago. As a story of human and scientific endeavour it is an excellent read.
TOPRA SYMPOSIA, DUBLIN 1-3 October 2012
This year’s Annual Symposium planning is well underway. It promises to be an even bigger and better event with the Main Symposium, and accompanying MedTech and Vet Symposia, as well as an SME Day and a range of parallel sessions. To get the latest on all the Symposium developments on our specially designated web pages go to www.toprasymposium.org. Meanwhile see a photo of the Symposium Working Party in action on page 3. Erik Smit, Marketing and Communications Manager
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SPONSOR NEWS We’re delighted to announce that PPD has joined our distinguished team of Regulatory Affairs supporters. PPD is sponsoring the COMMUNICATION category. Dr Henrietta Ukwu, the CRO’s Senior Vice President, Global Regulatory Affairs, explains: ‘At PPD, we understand effective and ongoing communication of global regulatory intelligence are essential to overcoming regulatory hurdles and ensuring quality submissions. We are proud to sponsor the TOPRA Award recognising excellence in communication.’ PPD joins a growing number of category sponsors, including Samarind which is supporting INNOVATION and Thomson Reuters which is supporting EDUCATION. For information on our sponsors go to www.regulatoryaffairsawards.org. Your organisation can also be aligned with our prestigious Awards Programme, either as a category sponsor or as an Awards Champion giving general support to the programme. This is an ideal opportunity to promote your company in a commercially appropriate and highly visible way! For further information about the 2012 TOPRA Awards, please contact Mark Wilkins, by email mark. wilkins@ashridgecommunications.com or telephone: +44 (0)1753 714999.
TOPRA Awards Update 2012 It’s time to prepare your nominations! COUNTING DOWN TO 22 JUNE! It’s time to register your interest in nominating your colleagues and completing your nomination forms. There are still a few weeks left to make your nominations.
There are three ways to find out more:
• Go to www.regulatoryaffairsawards.
Which category suits your regulatory ‘Star’? Horizon: Celebrating the ‘rising stars’ of the profession Support: Recognising companies that support the regulatory process in so many ways
org and register
Innovation: Proving that Regulatory Affairs can produce innovative ideas & solutions to problems
(0) 20 7510 2578 and leave a message.
Communication: Demonstrating the excellent communication, in whatever form, that is the cornerstone of regulatory work
• Email your query to awards@topra.org • Call the TOPRA Awards hotline on +44 A member of the Awards team will get back to you with an answer to your question or to provide some additional support.
We’re here to help The TOPRA Awards team are happy to help you through the nomination process. You can make your entry entirely online but we do have Word versions of the nomination forms and related documentation if that is easier. Just let us know!
Education: Thanking those who ensure that regulatory professionals have the skills and knowledge to do their job well Inspiration:: Thanking the leaders and those who have inspired us to do even greater things Achievement: Recognising exceptional contribution to the regulatory profession throughout a career.
For more information on entering, the categories, judging criteria and deadlines go to: www.regulatoryaffairsawards.org
TOPRA In Europe goes from strength to strength The TOPRA In initiative, which was started in 2011, serves the needs of Regulatory Affairs professionals living and working in different countries by providing an informal forum for networking, meetings and discussion at a local level. The initiative, which has seen an average 15% growth in membership across the countries, has continued to grow with seven countries spanning Austria, France, Germany, Ireland, Italy, Sweden and Switzerland now participating. All have held successful networking meetings ranging from informal discussions to focused presentation sessions and are planning their next activities. TOPRA In Austria will hold their next event mid-June within the scope of the TOPRA MSc Module 1 course. TOPRA In Ireland is organising an evening networking event in late June following a successful joint meeting with the IMB back in
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March. The next TOPRA In Italy meeting is scheduled for Rome around September/October. TOPRA In Italy is also looking at holding some future webinars to encompass colleagues who may not be able to travel to venues. TOPRA In Sweden continues to grow and plans to extend its network to include Denmark. An event is being planned for Malmo in September with the main event being scheduled for October/November in Stockholm including involvement from the MPA. Mid-June will also see the TOPRA In Switzerland group meeting in Zurich including participation from Swissmedic. Further information on the activities of the TOPRA In groups can be found on the TOPRA website under ‘TOPRA In’ or by contacting Neil Fisher at neil@topra.org or Aine Kane at aine@topra.org. Aine Kane, TOPRA EU Board Representative
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Modules for everyone! TOPRA volunteers enjoy a working lunch during DIA in Copenhagen in March. Members of the Annual TOPRA Symposium and EMA annual update working parties got together over lunch to compare programmes so that the two programmes will be complementary to one another. The Symposium team will be off to Dublin in June for its 3rd meeting with the IMB to finalise the programme and the EMA team had its first team meeting with EMA on 25 April. Keep an eye on the TOPRA website for details of these two key events for your calendar. Christopher Bailey, RI and Training Manager
TOPRA Staff WHO’SWHO A series in which InTouch profiles members of TOPRA’s office team Neil Fisher - Director of Education and Training Neil joined TOPRA at the end of 2007 and he is responsible for the management and development of TOPRA’s wide range of educational and training programmes. Ensuring that standards are maintained and identifying new modes of learning and new areas of interest for healthcare regulatory professionals are key elements of his role. Neil has a long career in education both in the public and private sector. He was an Assistant Principal of a Further Higher Education College, before moving into the private sector where he headed up the National Consortium of Colleges Workforce Development sector. Latterly he worked as a consultant for more than 20 colleges nationwide before joining TOPRA. What does Neil like most about TOPRA? ‘Working with the various working parties is both challenging and enjoyable, you meet a wide range of interesting people,’ he says. So how does Neil spend his time when not working on TOPRA’s behalf? ‘I have two children who take up a lot of my time,’ he says, adding ‘I have recently taken up boxing which I am finding very therapeutic.’ You can contact Neil for information on TOPRA’s existing educational and training offerings and please do suggest any new initiatives/topics that you feel would be useful for TOPRA to develop for the future. Just email neil@topra.org.
The TOPRA MSc modules are not just taken by students, but also by short course delegates. The recent Module 9, which was held in Cambridge last month, is a good case in point. This course appealed to RA professionals who have recently moved into biological and advanced therapy products and needed to learn rapidly about these fields. Module 9 on Registration of Biological, Biotechnology and Advanced Therapy Products focuses on the scientific principles underpinning development of such products and how the inherent complexities impact on regulation. It attracted 33 delegates from across Europe, including the UK, Ireland, Switzerland, Spain, Germany, France, Belgium and the Netherlands. A wide range of companies and organisations were represented by delegates and speakers, including Moorfields Pharmaceuticals, the MHRA, Parexel, Biogen Idec, Merck Serono, Eli Lilly, Abbott, Bayer, Xendo, Merial, Nycomed and King’s College, London. We were delighted to welcome three new students to the course from GSK, Merck Serono and Vetmedica, based in the UK, Ireland and Germany respectively. We were also joined by nine delegates who are not currently studying for their MSc in Regulatory Affairs. Our next module is Strategic Planning in Regulatory Affairs and will take place in Vienna, Austria, at the Arcotel Kaiserwasser from 12-14 June. Whether you are a student or not, we will be happy to answer any questions you may have – and look forward to seeing you there. Go to www.topra.org/events for further information and a booking form. Kay Wood, MSc Administrator
TOPRA Advisory Council new members The TOPRA Advisory Council is a group of some of the most eminent members of the regulatory community which exists to provide advice and support to the TOPRA Board as it sets the strategy for TOPRA. This group might suggest new areas of training for example, or give helpful feedback on how TOPRA is perceived in the regulatory world. It also acts as a useful sounding board for new ideas. Many Advisory Council members also act as speakers at conferences, Awards judges or help TOPRA in a variety of practical ways. The Council was set up when TOPRA was founded and we have some very long-standing and dedicated members. However the time has come for a few to step down and we would like to publically thank Jytte Lynvig, Prof Tamas Paal, Noel Wathion and Graham Higson for their wise counsel and unswerving support in the past years. The new members will join the Advisory Council from its next meeting in July 2012. They are:
• • • •
Mel Walker, Senior Director Value Expert Engagement & Collaborations at GlaxoSmithKline Axel Breitstadt, Executive Director Regulatory Affairs Europe, Merck Sharp & Dohme Rui Santos Ivo, Professor, Medicines Regulation, University of Lisbon Faculty of Pharmacy and Vice-President, Central Administration of the Health System (ACSS), Ministry of Health, Lisbon, Portugal Martina Cvelbar, Director, Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.
We’d like to thank these new members for their commitment to TOPRA and welcome them onto the Council. If any TOPRA members have any questions about the Advisory Council, please email lynda@topra.org.
w w w. t o p ra . o r g / i n t o u c h
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A sad goodbye to a valued colleague
InTouch Editors: Jenine Willis, Greer Deal and Virginia Guellal
Linda Woods (1962-2012)
How to contact InTouch
It is with great regret that TOPRA reports the death of member Linda Woods last month. Linda had a long and varied career in Regulatory Affairs. Latterly, she established her consultancy company, UKR Regulatory Affairs, based in Oxfordshire and it grew to comprise eight regulatory staff in two office locations handling a wide portfolio of clients.
InTouch welcomes contributions from TOPRA members.
TOPRA’s Regulatory Training Executive, Emma McNeely, gave birth to Sebastian John Earnest McNeely on 19 April at 7.40pm. He weighed 7lb 4oz. ‘He is settling in brilliantly and we’re all adjusting well to the new family dynamic (so far!)’, says Emma. Congratulations Emma, big sister, Eleanor, and dad, Gerard.
TOPRA’s
latest arrival!
A member of TOPRA since 1992, Linda was a member of the TOPRA Professionalism Committee, helping and advising on the preparation of presentations and information packs to take into universities and other career events. She regularly attended University seminars to tell the new generation of graduates about the role of Regulatory Affairs and they came away instilled with enthusiasm and understanding of the intellectual excitement such a role may offer in the future. Her enthusiasm and creativity on this committee was an inspiration and will be sadly missed. Linda was shortlisted in the INSPIRATION category at the 2010 TOPRA Awards for Regulatory Excellence. The nomination stated that Regulatory Affairs was not a job or a role for Linda but more a passion which she held dear. She strongly believed in helping to ensure knowledge was transferred to the next generation of professionals in this field. ‘It is rare to find an individual with so much genuine passion for a role and who wants to share it with others so that they too become captivated and drawn to either pursue it as a career or broaden their knowledge of the subject…’ ‘The way Linda built UKR and the people within it, the vibrant interaction with clients, graduate seminars, those new to the profession as well as new ventures being considered by her, ensured that all are inspired and gifted with the knowledge and genuine love of what she does.’ TOPRA has sent a message of condolence to Linda’s husband, Chris, and her children, Becky and Freddie. Lynda Wight, Executive Director
NEWTOPRAMEMBERS
TOPRA welcomes the following new members who joined recently. Mr Ali Ahmed Alqahtani, Wockhardt UK, Saudi Arabia Mr Gareth John Ambrose, Primevigilance, Guildford, UK Mr Stephen Bardsley, Craig and Hayward, Wallingford, UK Ms Nina Blazevic, Primevigilance, Croatia Dr Shera Dandapat, Johnson & Johnson PRD, High Wycombe, UK Miss Dhermita Desai, Walsall, UK Dr Corinne Dominquez, Medtronic, Tolochenaz, Switzerland* Ms Ivana Gavran, Primevigilance, Zagreb, Croatia Mr Stephen Hill, Newcastle upon Tyne, UK (Student) Miss Petra Jeevaratna, Parexel International, Uxbridge, UK Mr James Kelly, Waterford, Ireland
Mrs Zuzana Krausova, Arriello, Prague, Czech Republic Ms Agata Lazowska, Troisdorf, Germany (Student) Dr Sara McSweeney, London UK (Student) Dr Stephanie Melillo, Biogen Idec, USA Mr Frank Moseling, FJM Regulatory, Canterbury, UK Ms Ronnie Mundair, Pfizer, Tadworth, UK Miss Sanaz Namanloo, London (Student) Mr Jonathan Ng, Amgen, Uxbridge, UK Dr Nazia Noor, North Harrow, UK* Ms Orlaith O’Brien, Eirgen Pharma, Waterford, Ireland Mr Pierre-Frederic Omnes, Quintiles, Levallois Perret, France* Mr Stephen Ormesher, Pharmaserve NW, Liverpool, UK
Mrs Susan Page, Poole, UK Miss Sheena Patel, Dunstable, UK* Mr Sumeet Patel, Stanmore, UK (Student) Mr Jitendra Patil, Amdipharm, Basildon, UK* Ms Catherine Paulen, Quintiles, Illkirch, France Mr Matthieu Peigne, F. Hoffman La-Roche, Basel, Switzerland Mrs Vishva Purohit, Dunstable, UK Ms Antonia Rizk, Reckitt Benckiser Healthcare (UK), Hull, UK Mr Wilberto Robles, Dorado, Puerto Rico Mr Julio Romero, Crawley, UK Mr Paul Rooney, Sandoz, Camberley, UK Mr David Ross, Abbott Laboratories, USA Mr Atif Saeed, Walton-onThames, UK*
Ms Oxana Sapunova, Alcon Labs, Moscow, Russian Federation Mrs Joanna Schmidt, Abbott, Ludwigshafen, Germany* Mrs Payel Seth, Teva UK, Harlow, UK Miss Rebecca Stoner, Cancer Research UK, London, UK Mr Neal Storm, Amgen, USA* Mr Thomas Stromquist, Swedish Orphan Biovitrum, Stockholm, Sweden Ms Katarzyna Szkapiaka, Berkhamsted, UK* Mr Antony Thambiah, London, UK (Student) Mrs Theodora Toumbi, Limassol, Cyprus* Mrs Valerie Vieilledent, Medtronic BioPharma, Tolochenaz, Switzerland Mr Nikola Vukanica, Pfizer, Peopack, US *Registered Member
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
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