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T he T O P R A N ewsletter – K eepin g members in T ouch
In this issue... While many of us are turning our thoughts to holidays, why not take the opportunity to reflect on becoming a member of the TOPRA Board? This is a fantastic opportunity to raise your profile, network with your colleagues and peers, make new friends and attend TOPRA events. Now that’s got to be a great summer bargain! TOPRA’s commitment to lifelong learning continues with more information about the MSc modules and news of our latest successful graduates on page 3. By the way, it’s great to see that some people can manage to fit in some free time between work and learning (see back page). We’d love to learn more about you and your hobbies. Remember, ‘a picture is worth a thousand words’. It’s great to announce InTouch has a new co-editor: Ishbel MacDonald. I’m sure you’ll all join me in welcoming her to the team and I, for one, am looking forward to her first InTouch introduction. Greer Deal, co-editor
July/Augu st 2013
A chance to participate! A message from Patrizia Nestby, TOPRA President
The first half of the year has passed incredibly quickly, perhaps because it was so full of exciting activities and accomplishments. One of the major achievements of the year to date is the validation of the TOPRA MSc at the University of Hertfordshire, which is offering new opportunities to our members. Many successful meetings have also been held on a broad variety of topics. It is said that June’s pharmacovigilance meeting held in Brussels may have had the longest Q&A session ever in the history of TOPRA meetings, lasting for over an hour! It followed three excellent presentations by Helen Lee (European Commission), Almath Spooner (Irish Medicines Board and Vice Chair PRAC) and Sabine Straus (Medicines Evaluation Board). We are now well into July and many of us are leaving for our summer holidays. It is an excellent time for reflection and one of the questions I would like you to consider during the summer months is whether you would be interested in joining the TOPRA Board. The official call for nominations will be issued in August; the deadline for receipt of nominations will be Monday 30 September. With four Directors standing down and a President-Elect to be elected, there is ample opportunity for you to get involved. The following considerations may assist your deliberations.
How could TOPRA benefit if you are elected for a position on the Board? Will your passion for healthcare regulatory affairs inspire and support TOPRA to continue to excel in promoting the profession, offering an independent platform for debate and providing high quality training and opportunities for networking with peers? TOPRA continues to evolve as a membership organisation of the future and your strategic insight can further shape this ongoing change. What is in it for you? A position on the Board offers you the opportunity to help shape our membership organisation, thereby ensuring that we meet all facets of members’ needs. You will be able to directly
interact with peers from very different backgrounds, such as industry, regulators, European Commission, academia and patients. It is an excellent way to extend your professional network, share experiences and best practices. An additional benefit is that TOPRA’s events are free for Board members providing you with the unique opportunity to participate at these events with minimal costs involved. While enjoying the warm sunshine, going on a leisurely hike in the woods, or lying on the beach with a cocktail in your hand, please do reflect on the opportunity to nominate yourself for a position on the Board. Meanwhile, I wish you all a fantastic summer!
TOPRA is delighted to announce that it has been accepted as a member of the Science Council The Science Council is a membership organisation that brings together more than 40 learned societies and professional bodies across science and its applications. It raises awareness of the profession of scientist, and furthers high standards of competence and the safe and effective application of science. You can read about TOPRA’s acceptance to this elite group on http://www.sciencecouncil.org/content/science-councilwelcomes-two-new-members. Membership of the Science Council will give TOPRA further opportunities to promote the regulatory profession, to underline its scientific nature and expand its professional standing.
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Nominations are now closed for this year’s Regulatory Affairs Awards programme
Regulatory Affairs Awards UPDATE We have had a pleasing number of entries from a wide range of specialties and geographical locations. The entries are now with our distinguished panel of judges, who are leading figures in industry, regulatory bodies and academia. Look out for the shortlisted nominees announcement in mid-September.
NEW SPONSOR! TOPRA is delighted to welcome Clinical Professionals as a Category Sponsor for the first time. Clinical Professionals is supporting the INSPIRATION Award this year. ‘Clinical Professionals has been privileged to support the career development of hundreds of regulatory affairs professionals over the years, and we have seen many of our colleagues develop into truly inspirational leaders within this demanding profession,’ explains James Nyssen, the company’s CEO. ‘We feel honoured to be recognising the achievements of some truly inspirational leaders at this prestigious event.’
Clinical Professionals focuses on regulatory affairs in the R&D, pharma, biotechnology, devices and CRO industries throughout Europe. It is one of Europe’s leading pharmaceutical research and development staffing businesses. Clinical Professionals join Samarind RMS, which is supporting the INNOVATION Award again this year. Samarind, a leading provider of software to the regulatory profession, won the Innovation Award in the 2010 Awards. TOPRA is pleased to accept the support of two successful service providers within the regulatory sector who are committed to showcasing the best of regulatory affairs through the Regulatory Affairs Awards programme.
THE VENUE Meanwhile, planning for the Awards Dinner and Ceremony is well under way. This year the Awards will be held at the prestigious Institute of Directors in London’s Pall Mall on 27 November.
samarind RMS
For full details and information on how you can secure your place at the ceremony and accompanying TOPRA Annual Lecture go to www.regulatoryaffairsawards.org.
DATES FOR YOUR DIARY...
In response to member feedback, the TOPRA Board will give a short update on its activities and progress in the past year at the Annual Symposium in Lisbon on Thursday 17 October. This will be a chance for you to get to know who TOPRA Board members are and interact with them in the informal networking sessions at this flagship meeting.
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This year the Annual Review Meeting (which replaced the old AGM in our constitution) will take place in u London on the afternoon of 27 November. fG Pro All members are invited to attend the Review meeting, which this year will include a short Extraordinary General Meeting to approve minor amendments to our Articles of Association. The Annual Review is a chance to hear what the organisation has been doing, to question the Board, to see details of the finances and to hear the results of the Board elections that will be held in the preceding months. In this way TOPRA is transparent and accountable to all its members. The Annual Review Meeting will be followed by the TOPRA Annual Lecture, given this year by Professor Guido Rasi, Executive Director of the EMA, and the TOPRA Awards for Regulatory Excellence. All events will be held at the Institute of Directors, Pall Mall, London – a lovely venue for a great afternoon and evening of activities that focus on the very best in regulatory affairs. Please keep a look out for further announcements and booking forms: and save the date in your diary NOW!
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July/Augus t 2013
Continuing Professional Development
Access to TOPRA modules Did you know that you can attend TOPRA MSc modules without signing up to undertake the qualification? Last month eight non-student delegates attended our ‘Regulatory Strategy: The marketplace’ module held in Brighton UK for their continuing professional development. They joined 19 MSc Regulatory Affairs students from all over Europe and many different pharmaceutical companies. The course covered the regulatory aspects of company strategy in commercialising products and maintaining the brand, and exploring any issues likely to arise during this process and how regulatory professionals can advise on resolving them. Speakers include Nimo Ahmed from the MHRA, who outlined the role of the MHRA enforcement group and how it deals with falsified medical products; and Professor Theo Raynor from the University of Leeds and Co-founder and Academic Advisor at Luto Research, who explained SPCs and how to use them.
Attending modules for CPD If your background is in pharmaceuticals, but you want to find out more about medical devices and how they are regulated, then an upcoming MSc in Regulatory Affairs module from 3–5 September could be for you. Attending the ‘Medical Device Regulatory Affairs’ module as a short course at DeVere Latimer House, Chesham, UK will provide experienced regulatory professionals with the insight they need. Go to www.topra.org/events for further information. However, if you see your career focusing on medical devices, we are running ‘Principles of European Medical Technology Regulatory Affairs’, on 10–12 September. This is the first module of the MSc in Medical Technology with Cranfield University (see further details of the qualification below or go to www.topra.org/mscmtra).
Congratulations to our Cranfield graduates!
Sarah Bean, Paul Browning and Robert Hofland (see below) received their MSc in Medical Technology Regulatory Affairs at the Cranfield Graduation Ceremony on the Bedfordshire campus on 6 June. Another TOPRA student, Angela Robertson, was awarded her MSc in absentia. The MSc course is based on eight compulsory three-day modules plus an integrating portfolio and a research project presented as a thesis. The MSc may take up to a maximum of three years to complete. Available on a part-time basis only, the course is designed to be flexible in order to fit around existing employment and responsibilities. From L–R: Paul Browning, Sarah Bean and Robert Hofland.
News From the Board... The TOPRA Board meeting in July had a financial focus. It was time for TOPRA’s financial advisers, Rathbones, to report to the Board on how they are managing our investments. It was reassuring to learn that the TOPRA investments, which are managed on a low-risk basis, are actually performing quite well against high-risk benchmarks! The Board also heard about the progress office staff are making in the selection of a new member relationship database which will bring many benefits to TOPRA members in the future. The possibilities have been narrowed down to a shortlist of two and the Board gave the go-ahead for the team to make a final selection and progress the implementation for early 2014. The management of virtual services to members, including online training and resources, was also debated and a strategy agreed for the next stage. Our new Head of Membership, Duncan Judd, reviewed his activities after his first few weeks in the role, focusing on his work to bring back lapsed members and to engage with the SPIN groups and TOPRA In... teams. Duncan will present a formal membership strategy at the next Board meeting. The Board also agreed a new policy on the publication of MSc theses and took the opportunity to review the myriad other policies the organisation has, covering everything from employment law to working party guidelines. It was agreed that the time has come for TOPRA to set up an independent audit committee to review these policies on a regular basis. Are there any volunteers out there who would like to contribute to the good governance of TOPRA by being part of this? If so please email lynda@topra.org for more information.
Membership can be tax efficient! Did you realise that your TOPRA membership fee is only around £15 per month? Taken against the cost of a meal out, a tank of petrol, a theatre ticket or a round of drinks it’s not really very much for being able to demonstrate your professional commitment and being part of a network of like-minded individuals in a respected organisation. The monthly journal alone is a valuable resource – and did you know members can search it online? But if times are tight please remember that membership fees are tax-deductible in many EU states, and that TOPRA offers concessions for retired members and those on career breaks. Contact Duncan Judd for more information (duncan@topra.org).
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July/Augu st 2013
Welcome to the team, ishbel!
InTouch Editors:
Ishbel MacDonald is joining the InTouch editorial team as a co-editor. Ishbel is a regulatory affairs consultant based in Scotland. She has a PhD from Reading University based on research into the HPLC of water-soluble vitamins and a first degree in Food Science from the University of Strathclyde. Previous roles have included being a director of regulatory and clinical affairs at Controlled Therapeutics, where she was responsible for worldwide regulatory negotiation and approvals.
Since going freelance in 2000, her consultancy has provided regulatory and drug development advice to a wide range of pharmaceutical and food supplement companies in Europe, the US, the Far East and Australia. She specialises in working with start-up companies and SMEs on regulatory strategy, gap analysis, CTAs/INDs, MAAs/NDAs, regulatory agency meetings, lifecycle management and regulatory due diligence.
How do you spend your free time?
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). 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
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Jenine Willis, Greer Deal and Ishbel MacDonald
TOPRA staff members have a variety of hobbies. Regulatory Intelligence and Training Manager, Christopher Bailey, spent one of his recent holidays perfecting his carpentry skills (see left). Meanwhile Marketing Manager Erik Smit (see picture – he’s the one with the yellow cap) has tried hot-air ballooning. What kind of hobbies do you enjoy in your free time? We’d love to hear from you – and see the photographic evidence. The best images will appear in InTouch or on the InTouch web pages.
NEWTOPRAMEMBERS
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 welcomes the following new members who joined recently Dr Simon Larkin, Consultant, Lyme Regis, UK* Mrs Patrycja Prus-Lewening, DRA Senior Labelling/ Regulatory Intelligence Manager, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland Ms Michelle Du Preez, Regulatory Affairs Officer, Novo Nordisk, Crawley, UK Ms Ghazal Rehman, Regulatory Affairs Officer, Crawford Healthcare Ltd, Knutsford, UK* Ms Nathalie Boeglin, Associate Director Global Regulatory Affairs, Quintiles, RueilMalmaison, France Ms Amara Tonkiss, Global Regulatory Associate, Reckitt Benckiser, Hull, UK*
Mrs Gail McGuire, Regulatory & Start Up Lead, Quintiles, Livingston, UK Miss Esther Fakeye, Regulatory Affairs Manager, Tunbridge Wells, UK* Ms Joana Carrasqueira, Entroncamento, Portugal (Student) Miss Daria Monogiou Belik, White City, UK (Student) Dr Qamar Nawaz, Birmingham, UK* Mr Olivier Heloir, Marcoing, France (Student) Mr Jiten Patel, Pharmacist, Harrow, UK Mr Liam Jenkins, Ceredigion, UK (Student) Ms Lora Graff, Labelling Manager RA, The Netherlands*
Mrs Rizwana Sproule, Executive Director of Regulatory Affairs, Camarillo, USA* Dr Ana De Andres Gomez, Regulatory Affairs Manager, AstraZeneca, Leek, UK* Mrs Ingrid Brotherhood, Macclesfield, UK* Miss Claire McDonald, Regulatory Affairs Associate, Amgen Ltd, Cambridge, UK Mrs Sharon Cunningham, Drug Registration Officer, Macfarlan Smith, Edinburgh, UK Dr Steven Donald, Bassersdorf, Switzerland Ms Fatima Begum, London, UK Miss Olivia Maguire, Solihull, UK (Student) Miss Anna Raphael, London, UK (Student)
Miss Alice Edgeworth, Regulatory Operations Associate, Gilead Sciences International Ltd, Abington, UK Dr Roberto Liddi, Head of Corporate QARA, Renishaw plc, Abingdon-on-Thames, UK* Mr Sarvanan Sakthivel, Walthamstow, UK Dr Angela Garcia-Jimenez, Crucell Sweden AB, Solna, Sweden* Ms Paraskevi Venizelou, CMC & RA Consultant, Quality RA, BP Leiden, The Netherlands* Mr David Lonergan, Regulatory Affairs Officer, EirGen Pharma Ltd, Waterford, Ireland* Dr Ouannassa Rached, Pharmacy Manager, Bristol, UK
*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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