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THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH
In this issue... Healthcare regulatory affairs is often perceived as a niche specialty, but actually it is a vast subject. Therefore, as a regulatory professional it is vital to build up a network of colleagues and connections because, guess what, no one individual can know it all! It is often more important to know where to find the information, or who to contact, rather than expecting to have all the answers. It’s great to see that the MSc in Regulatory Affairs is to continue with the support of the University of Hertfordshire, which goes to show that regulatory affairs is a career choice. With the TOPRA Awards not so far away now, this is your chance to nominate one of your colleagues who you think has that special quality about them which should be recognised. It’s also everyone’s opportunity to raise the profile of our profession. Talking about that ‘special quality’, thank you, Virginia, for being a great co-editor (see back page) – let’s stay connected. Greer Deal, co-editor
Validating relationships A message from Patrizia Nestby, TOPRA President
A pivotal role for TOPRA, as a professional membership organisation, is to provide high-quality education for its members, which is particularly important given the dynamic nature of the regulatory arena. In addition to the well-known introductory and other continuing professional development courses, TOPRA has a long history of successfully delivering two MSc courses. These Masters’ degrees are internationally recognised and are validated by partner institutions: the MSc in Regulatory Affairs was validated by the University of Wales; and the MSc in Medical Technology is validated by Cranfield University. At the beginning of my regulatory career, I completed the MSc in Regulatory Affairs and found it both inspiring and an invaluable foundation for my further development. It introduced every facet of regulatory affairs from a scientific, legal and commercial perspective. Personally and professionally, I can do nothing but advocate this Masters’ degree not only for our members but for their companies who will undoubtedly reap the benefits this course affords. In October 2011, the University of Wales announced it would no longer be validating any external institutions, including TOPRA. To ensure the long-term continuity of the TOPRA MSc, the TOPRA Board decided that this was an ideal opportunity to further develop the MSc by validating with another institution that would provide
even greater commitment to high-quality regulatory education working with TOPRA.
Exciting transition
The TOPRA office undertook a great deal of activity to select a suitable validating institution. I am very pleased to announce that as a result of all this hard work, the TOPRA MSc in Regulatory Affairs will now be validated by the University of Hertfordshire (see Box). This university is one of the UK’s leading business-facing universities. TOPRA will soon
release more information to existing and new students about this exciting transition. I would like to take this opportunity to thank the TOPRA staff for all their efforts to establish a relationship with such a highly respected validating institution, thereby ensuring the continuation of the MSc. I am convinced that this new relationship will offer the opportunity of a fresh start and will further evolve formal education provision in regulatory affairs.
Announcement MSc in Regulatory Affairs is now validated by the University of Hertfordshire. The University of Hertfordshire is one of the UK’s leading business-facing universities. It was awarded ‘Entrepreneurial University of the Year 2010’ by the Times Higher Education (THE) magazine. TOPRA’s successful modular Masters in Regulatory Affairs has been offered since 1989 and has seen more than 200 students graduate so far. The transfer to the University of Hertfordshire will ensure the long-term continuity of the TOPRA MSc to both new and existing students. Neil Fisher, TOPRA’s Director of Education and Training, said: ‘To be able to continue to offer our MSc with a high quality and well-respected institution means that this MSc qualification will continue to be regarded internationally as a relevant and high-quality award.’ The TOPRA MSc will be managed within Pharmacy, a department in the School of Life and Medical Sciences at the University of Hertfordshire. Benefits of partnering with this university include: ● Excellent library facilities ● Close links with leading pharmaceutical companies ● Other prestigious pharmaceutical courses are also validated, including an MSc in Pharmacovigilance.
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Veterinary Symposium
Working Party planning well underway A key part of the TOPRA Annual Symposia is the Veterinary Symposium, which will run from 17-18 October in Lisbon, Portugal, this year. The programme is now taking shape. On 9 April Ray Harding (chair of the working party) and Christopher Bailey of TOPRA visited the Veterinary agency DGAV (DirecçãoGeral de Alimentação e Veterinária) with a local member of the working party, João Lourenco of Zoetis, Portugal. At the DGAV they met with Helena Ponte (veterinary medicines and plant protection department director), Maria Azevedo Mendes (veterinary medicines chief unit) and Inês Dias (scientific staff). A very cordial discussion took place and Helena welcomed the opportunity to work with TOPRA on the 2013 Veterinary Symposium. The meeting ended with a visit to the rooftop of DGAV (pictured) to admire the panoramic views of the castle and waterfront. Go to www.toprasymposium.org for all the latest updates.
MSc Module focuses on regulatory requirements in clinical research Module 5 of the TOPRA MSc course ‘Regulatory Control of Clinical Operations’ was held in Prague, Czech Republic on 16–18 April. This module focuses on the practical regulatory aspects of global clinical research, providing effective advice on the regulatory issues likely to arise during clinical programmes. The course was well attended with delegates from Czech Republic, Germany, France, the Netherlands, Portugal, Ireland, Denmark and the UK; from companies including Merial, H Lundbeck, K-Pharma, Gruenethal, Teva, Boehringer Ingelheim and Bonifar. We welcomed four new students to the course from Tillomed Laboratories, DSTL, K-Pharma Consulting and Teva. Several non-MSc delegates also joined the module. Paul McInulty the module leader and his team, Angela Stokes and Eva Kopecna, produced an exciting programme. Speakers included Dr Alexandra Hoebel from AGES, Austria, and Elaine Godfrey from the UK’s MHRA, who presented an agency perspective on submissions. They were joined by speakers from the Czech Republic. Our next MSc Module 6 on ‘Regulatory Strategy: The Market Place’ will take place at DeVere The Grand Hotel, Brighton, UK from 11–13 June 2013. Please go to www.topra.org/events for further information and a booking form.
Patients seek Empowerment Empower was founded by a patient with motor neurone disease (MND) and is aiming to introduce a protocol into the UK to allow patients with very rare terminal diseases to have early access to new medicines through modification of their legal remedies against the developer and clinicians concerned. Lynda Wight attended a summit at the UK Parliament to hear a number of interested parties debate the issues. MPs, industry representatives, patients, and clinical investigators highlighted the tensions between the current UK infrastructure, the rapid revolution in scientific advances and the current regulatory requirements that mean that innovative new treatments for such diseases take too long and are too expensive to bring to market – and cannot always be made available to patients when they are licensed. The importance of collaboration between innovators, healthcare providers and patient charities was highlighted. This fascinating debate was made more poignant by the video of the founder of Empower, Les Halpin, for whom any changes will come too late, but who is devoting all his energies to trying to change the status quo for future patients in his position. For more information go to www.accesstomedicine.co.uk.
Getting to know you – Introductory Course students mix learning and networking
Students from last month’s Spring Introductory Course get to work on the practical case studies and sessions (pictured left and right) and to socialise later (middle). The Autumn Introductory Course will take place on 3–7 November in Berlin, Germany. For more information go to www.topra.org/introductorycourse.
T H E TOPR A N E WSLE T TER – K EEPI NG MEM B E RS IN TOUC H
Enter NOW
TOPRA Awards 2013 Championing the Awards
Would you like to be an Ambassador?
This year’s nomination process is open and the Awards Working Party invites you to enter your colleagues in the relevant categories. Members of the Awards Working Party have initiated the process by each championing one particular Award as follows:
We are looking for volunteers to help the Working Party by being Ambassadors to spread the word about the Awards in the profession. Our aim is to ensure that dynamic, committed professionals working in the sector are recognised for the important contributions they have made in their respective areas.
Inspiration
To achieve this goal, our Ambassadors will reach out to colleagues or clients in their professional networks to champion awareness of the Awards categories and their timelines, along with sourcing and encouraging potential nominees.
For individuals who inspire their fellow professionals in their work, or encourage them to take their regulatory career further, or to acknowledge excellence in leadership Championed by Craig McCarthy, CAMPHARM Horizon For individuals with less than three years’ experience in the regulatory profession who have shown exceptional promise in the field Championed by Dianne Lee, DLRC Communication This category recognises the importance of clear and effective communication in regulatory affairs whether it be professional to professional or for wider publication Championed by Monique Garrett, Prism Works Education For designing, developing, and delivering regulatory education – from formal qualifications to in-house training Championed by John Deavin, Deavin Associates Innovation Recognises those who have identified inefficient processes or other regulatory issues and have resolved them in an innovative fashion Championed by Gerald Thompson, Boots Support Recognising the role of support organisations in delivering effective consultancy or other business solutions to regulatory teams and companies
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Ambassadors do not have to focus on one category, you can champion all or any of the categories you can identify with. This is an exciting and rewarding role which will enable you to become personally involved in recognising the achievements made by your colleagues at all levels of the industry. The Awards website (www. regulatoryaffairsawards.org) contains details of our prestigious judging panel, the categories of Awards and links to the nomination forms. If you would like to get involved in helping us promote our profession and motivate the very best people in it by encouraging more nominations to this year’s event (or by making one yourself!), please contact Rachel Cook (rachel@topra.org) for further information. For more information or to nominate, visit www.regulatoryaffairsawards.org.
AWARDS TIMELINES Register your interest in entering the Awards – NOW! Friday 20 June
Championed by Elke Hofer-Litzlbauer, Baxter
Closing date –
Life Time Achievement
Shortlist announced –
Acknowledging an individual’s lifetime of achievement and contribution to developing regulatory affairs Championed by Alan Hunter, past president, TOPRA Don’t forget to follow us on Twitter – @TOPRANEWS #TOPRAAwards2013.
samarind RMS
Awards ceremony –
mid-September
27 November
The TOPRA Regulatory Affairs Awards 2013 will be held in London, UK. Watch out for news updates on the event at www.regulatory affairsawards.org.
SUPPORTER OF THE INNOVATION CATEGORY
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InTouch Editors:
Thank you Virginia!
Jenine Willis, Greer Deal and Virginia Guellal
After several years as co-editor of InTouch, Virginia Guellal is hanging up her shoes. Her co-editor Greer Deal says: ‘Virginia has been such a pleasure to work with: always professional and great fun. I shall miss her emails sent in the early hours of the morning and her never-ending enthusiasm for her work and for our profession. Thank you, Virginia, for your help and support. ‘ If you would like to join the InTouch editiorial team, please email jenine@topra.org.
How to contact InTouch InTouch welcomes contributions from TOPRA members.
Virginia with her daughter at a charity run last year
Founder member receives certificate Executive Director Lynda Wight and Alan Hunter, Chair of the ‘STAR’ Panel– which ensures that success and achievement is recognised by TOPRA – visited the home of R Keith Greenwood to present him with his Honorary Life Membership certificate. Keith was a founder member of this organisation back in the 1970s and served as Chairman and leader of our Education efforts when some of our most important training initiatives were launched. He established the financial philosophy for the organisation that has ensured its continued stability and opportunity for growth. He will be remembered with affection for his incisive and witty contributions to our conferences both from the platform and audience. In the wider world Keith was a pioneer in the emerging CRO industry and founded the Regulatory Affairs Journal. Keith was awarded Honorary Life Membership some years ago but a bout of ill health, now resolved, prevented him from attending a presentation ceremony. Keith sends good wishes to his many friends in TOPRA and would be delighted to hear from them. Contact the office for more information.
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently Dr Annabella Amatulli, Regulatory Affairs Specialist, Italy* Ms Jane Bainbridge, New Jersey, US*
Mr Michael Edwards, Brackley, UK
Miss Erika Mercer, Surbiton, UK*
Miss Gina Prat, Regulatory Affairs Affiliate, Amgen, Uxbridge, UK*
Miss Rosaleen Moylan, QA and RA Engineer and QP, ArcRoyal, Kells, Ireland*
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. © 2013 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 Email: 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
Dr Leslie Bannon, Regulatory Consultant, Switzerland*
Dr John Hares, Regulatory Affairs Associate Miss Malwina Niemczyk, Cambridge, UK Assistant, Alliance Pharmaceuticals, (Student) Chippenham, UK Ms Segren Bernard, Senior Consultant, Dr Nikolaos Charlaftis, Research Swindon, UK Mrs Hilde Bastaerts, Associate Director, Associate, Imperial College London, UK CMC Dossier Development, Janssen R&D, Ms Marissa Campbell, Regulatory Affairs Mr Paul Johnson, Consultant, Clinscisive Beerse, Belgium* Officer, Martindale Pharmaceuticals, Services, Auckland, New Zealand* Romford, UK Ms Inge Schorpion, Scientist, Beerse, Mr Rasan Vaid, Regulatory Affairs Project Mr Carl Brooker, Regulatory Project Belgium Manager, GlaxoSmithKline UK, Uxbridge, Manager, DLRC, Hertfordshire, UK* Mrs Karen Hill, Regulatory Affairs Manager, UK* Dr Catherine Davies, Regulatory Associate, Vascutek, Renfrewshire, UK Miss Rebecca Evans, Regulatory Affairs Reckitt Benckiser Healthcare, Hull, UK* Mrs Laura Kanter, Regulatory Affairs Officer, Wockhardt UK, Wrexham, UK* Mrs Claire Bailey, Regulatory Affairs Team Officer, HRA Pharma, France* Manager, AstraZeneca UK, Luton, UK* Mr Christopher Sharpe, Chesham, UK* Miss Nicole Liska, Cambridge, UK (Student) Mrs Claire Roche, Global CMC Manager, Dr Michael Titus, Maryland, US* Mrs Annie Martin, Cambridge, UK Pfizer, Co Dublin, Ireland* Miss Dunja Vukic, Pharmacovigilance Ms Martina Foster, Senior Regulatory Dr Costantino Congiatu, Regulatory Associate, PrimeVigilance, Zagreb, Croatia* Affairs Consultant, Real Regulatory, Dublin, Affairs Specialist, PPD, Cambridge, UK Dr Jennifer Yen, Cambridge, UK Ireland Mrs Jesantha Coy, Regulatory Affairs Ms Ana Zaccaro, Regulatory Affairs Miss Maria-Cristina Martin-Paniza, Manager, Allergan, Marlow, UK Manager, Takeda Global R & D Centre Deal, UK Ms Anna Cruz, Regulatory Affairs Senior (Europe), London, UK* Miss Sarah Masoudi, Chiswick, UK Associate, Alliance Pharmaceuticals, Chippenham, UK
(Student)
*Registered Member
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.
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