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Apr i l 2013
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
In this issue... As the weather begins to improve in the UK, there is more sunshine coming from the continent with news of TOPRA members based in Europe. In her editorial, Patrizia Nestby explains how TOPRA In the Netherlands is taking shape. And ‘Hola’ to TOPRA In Spain (see page 4). ¡Olé! The international focus continues, as we welcome our new Board members, from Germany and Croatia, who bring a wealth of expertise to our community (page 2). For more Board news see page 3. Congratulations to our new fellows, who are announced on page 2. And congratulations to the Spring Introductory Course Working Party (WP) on its 35th course. The chair, Steve Brookes, highlights what the course has meant to him... and how much it could mean to you. Last but not least, Craig McCarthy, who chairs the TOPRA Awards WP, reminds us of the importance of participating (page 3). As a previous nominator, I can confirm it is definitely worth nominating a colleague. Think about how proud they will be, and you will be, if your entry is shortlisted. Virginia Guellal, Co-editor
Reaching out
A message from Patrizia Nestby, TOPRA President For a couple of years now, TOPRA has been successfully running TOPRA In groups in seven European countries and has a well-established and active North America group. The aim of these groups is to provide a local forum for discussion and networking in the country where those regulatory professionals are based. Developing such groups is one of the commitments TOPRA has made as part of its strategic goals. Of course many regulatory professionals interact at an international level, but there is tremendous value in networking and sharing experiences with peers at a more local level. Also, there are regulatory matters that are specific to a country or region. This all explains the great enthusiasm for TOPRA In groups in many countries. Each TOPRA In is different: some start from scratch while others are built in collaboration with existing networks, as is typified by the group in my own country. We have chosen to collaborate with an established local regulatory network, Regulatory Netwerk Nederland (RegNed). TOPRA and RegNed have recently expressed a mutual interest in collaboration, primarily because both associations have very similar overall objectives, including supporting regulatory professionals in the pharmaceutical sector. We believe working together in a non-competitive way will
benefit all our members. RegNed was established in 2009 as a section of the Dutch Association for Pharmaceutical Medicine, which is a wellrespected association set up more than 50 years ago. RegNed provides a local platform for discussion and networking for regulatory professionals working on innovative, generic or overthe-counter pharmaceutical products in an agency or industry environment. In addition to running a parallel session at the annual day of the Dutch Association for Pharmaceutical Medicine, RegNed also holds conferences on topical subjects once or twice a year. As a first step in our
collaboration with RegNed, we are organising a joint meeting in the Netherlands in the second half of this year. The topic has yet to be finalised; if you have any suggestions we would be pleased to hear them. Please also let me know if you would be interested in helping to organise this event, which will be conducted in Dutch. It will be an exciting opportunity for all Dutch and non-Dutch TOPRA and RegNed members to meet and to share thoughts about how to further support the regulatory profession in the Netherlands.
Annual Symposium Early Bird offer – ends 30 June
The TOPRA Annual Symposium is the must-attend meeting of the regulatory calendar. The programme is developed by regulatory professionals for regulatory professionals, ensuring delegates leave the conference with all the information they need, provided by a wide range of key speakers from both agency and industry. It also offers comprehensive networking opportunities in pharmaceutical, medtech and veterinary regulatory affairs. Members should have received the first flyer for the 2013 Symposium. It contains the latest information on the programme, including sessions on the proposed Clinical Trial Regulation; the new EU Medical Device Legislation and developments in health technology assessment. Join us at the Annual Symposium, produced in conjunction with Infarmed, the Portuguese regulatory agency, on 16–18 October in Lisbon. Book now at the early bird rate until 30 June. Go to www.toprasymposium.org for all the latest updates.
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BOARD ANNOUNCEMENT
New members named
As reported in a previous edition of InTouch , the TOPRA Board 2012-13 had a vacancy for a Director due to the move of Jonathan Trethowan to the President Elect position. The Board had also performed an ‘audit’ to review its skill set and representation and identified some areas where it would be helpful to co-opt an additional member, as allowed by the TOPRA constitution (see http://www.topra.org/about-topra). As a result two members have been invited to join the Board and accepted: they were formally co-opted at the March meeting. The new members are:
Dr Christine Mayer-Nicolai
Christine has a PhD from the University of Würzburg (Pharmaceutical Chemistry and Medical History) and is a Fellow of TOPRA. She has worked at Allergan and the German trade body BPI. Her current position is as Senior Director, Global Regulatory & Scientific Policy, Europe, Merck Serono, Darmstadt, Germany. Christine has served on the EFPIA ERLC (European Regulatory Liaison Committee) since 2002 and the European Biopharmaceutical Enterprises’ (EBE’s) Regulatory and Technical Affairs Committee, Biosimilar Task Force and Clinical Trial topic group since 2010. She has given over 50 presentations in conferences and stakeholder meetings at national, European and international levels, including the MSc at the University of Bonn. She is also a session chair for the TOPRA Annual Review meeting.
Dr Ljiljana Markus-Cizelj
Ljiljana is Head of Service for Veterinary Medicinal Products, feed and animal by-products at the Ministry of Agriculture in Croatia. Ljiljana is a veterinarian with extensive experience in regulatory affairs in the European veterinary pharmaceutical industry. She has been active in the Federations of Veterinarians in Europe. Recently, Ljiljana was working with MSD Animal Health in the Netherlands but has now returned to Zagreb to take up the position of head of the national veterinary medicines regulatory authority at the Ministry of Agriculture in Croatia.
These new appointments greatly add to the breadth of experience on our Board and we look forward to their contribution. The co-options are in place until the next election at the end of 2013.
Congratulations
to our new Fellows
TOPRA is pleased to congratulate the following on election to Fellowship: Emma Du Four ● Tayce Connolly ● Lorraine Marsh All these members have made a significant contribution to our profession, whether through work with TOPRA or in other ways, and we are delighted to recognise them in this way. ●
Networking with fellow delegates is a key benefit of the course.
35 YEARS... AND STILL GOING STRONG This month TOPRA is running its 35th Spring Introductory Course (IC) in Regulatory Affairs. Steve Brookes, the chair of the Working Party, explains how he came to be involved with the course – and why the ICs are so satisfying for all the participants
SPRING INTRODUC TORY COURSE 15–19 APR I L , DORK ING, UK
My involvement with the course dates back to 1993, when I worked in the labelling, leaflets and advertising section of the MCA (now MHRA). The chair of the the Working Party (WP) at the time asked me if I could devise a case study on labelling and leaflets plus attend the course for a Q&A. I remember being given a tough grilling from a new crop of keen regulatory professionals and beginning virtually every answer with, ’Well, it depends…’.
However, the organisers invited me to stay for the course dinner and dance, where I saw the social side of the course and obvious camaraderie among the delegates. In 1997, I ‘jumped the fence’ into industry and attended the IC in 1998 (missing the League Cup final at Wembley to boot!). I can still honestly say that week was the most intensive training course of lectures and stretching case studies I’ve ever been on! Being ensconced in a hotel from Sunday to Friday and
‘enduring’ the week meant I formed close working ties with regulatory colleagues, with different experiences, academic backgrounds and industry roles. Without realising it, this was the start of my industry network, with whom I could talk through challenges, share experiences, learnings and laughs. A couple of years later I was asked to be a helper for the labelling and leaflet case study and, in 2001, I was invited onto the WP as the leader for that case study. Five years later I became the Chair of the Spring Introductory Course Working Party. It’s a position I continue to hold and enjoy today. Why do I still volunteer to do it? I enjoy being able to put something back into our profession, provide a foundation for and help mould a new generation of regulatory professionals, network with our speakers (including industry leaders and agency specialists) and, of course, get together every two months with my WP colleagues, some of whom I first met in Spring 1998.
T h e TOPR A N e wsle tt er – K eepi ng memb e r s in To uc h
TOPRA Awards 2013 Enter NOW
Have you thought about nominating your high-achieving support companies, consultants or staff for a Regulatory Affairs Award?
A message from Craig McCarthy, former TOPRA President and Chair of the Awards Working Party Having been involved in teams for most of my life – in regulatory affairs and the military – I always find it good to thank an individual who’s done an excellent job with well thought-out personal feedback or reward. However, it can be difficult to think of ways of recognising a proactive team member, leader or regulatory service company or consultant who has done an outstanding job, encouraging further regulatory excellence that makes a difference to our profession. Well, TOPRA over the past few years has provided us with an opportunity. By nominating individuals or teams you are indicating to them that you recognise their excellence and are motivating them to do even better in future. The TOPRA Regulatory Affairs Awards are staged to promote excellence in our profession and therefore I encourage you to support them. In addition the Awards evening is a great ‘must go to’ annual event for individuals or companies working in regulatory affairs, a chance to network with fellow professionals while celebrating regulatory excellence. Not only is there the stimulating Annual Lecture to start the evening off but also a sparkling reception, followed by a quality dinner, in lovely surroundings with a relaxed ambience, as you join in the celebrations of the winners. I therefore encourage you all to join the celebrations – nominate your colleagues and book a place at the Awards on 27 November. I also encourage companies working for regulatory clients to sponsor an Award, demonstrating their support for the profession and gaining great promotion for their company among current and future clients. I look forward to seeing you all at this prestigious event. For more information or to nominate, visit www.regulatoryaffairsawards.org. Don’t forget to follow us on Twitter – @TOPRANEWS #TOPRAAwards2013.
samarind RMS
News From the Board... TOPRA Board members met up for their bi-monthly face-to-face meeting last month. In summary: ● Two new members were co-opted on
to the Board – see elsewhere in this edition for more details ● The finances of TOPRA were reviewed
as usual although this month this included the staff salary review recommendations from the Finance Committee ● The strategy for maintaining
professional office premises for TOPRA when the current lease expires was also determined. It was agreed that the location near to the EMA was optimal ● There was detailed discussion on the
best way forward to develop ‘virtual’ services that would support regulatory professionals in the future. It was agreed that a formal proposal would be presented at the May meeting. If any member has strong views on this or would like to be part of the management team please e-mail neil@topra.org ● A proposal for how TOPRA can manage
the process for responding to relevant consultations was presented and many aspects agreed. A formal SOP will be written and shared with the Regulatory Intelligence SPIN group members for comment ● An update on the Awards 2013 and
SUPPORTER OF THE INNOVATION CATEGORY
AWARDSTIMELINES Register your interest in entering the Awards – NOW! Closing date –
April 2013
Friday 20 June
Shortlist announced – 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.
the TOPRA Annual Lecture was given – watch out for the announcement of our prestigious guest speaker! ● The Board reviewed a number of
relationships TOPRA has with other organisations and heard reports from the Executive Director on recent successful meetings at the EU Commission. All members can contact Board members via the emails on the website or via the TOPRA Office if they have any questions.
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K e e p i n g
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Apri l 2013
TOPRA In... goes to Spain
InTouch Editors:
TOPRA held its first TOPRA In Spain networking event last month, which was hosted by Alberto León Acero, director of Masters programmes, at the CESIF offices (Centro de Estudios Superiores de la Industria Farmacéutica) in Madrid, Spain. The event was very well supported with more than 30 delegates.
S PA I N
A lively discussion took place among the delegates and TOPRA representatives which helped to identify possible training needs and stakeholders with whom TOPRA could work in partnership on future activities. Many ideas were generated to help develop and promote regulatory affairs in Spain. At the event, former TOPRA Board member Collette Beglin, who is now based in Barcelona, was supported by Neil Fisher, the Director of Education and Training, in launching TOPRA In Spain. This initiative on the Iberian peninsula is timely with the upcoming Annual Symposium being held in Portugal this year. Collette is now setting up a TOPRA In Spain working party that will look to develop future small networking events to bring together regulatory professionals based in Spain. To participate in the working party, all that is required is a little time and enthusiasm to meet and discuss with other members (around five people) either face-to-face or by teleconference, to investigate possible areas of interest, identify the best geographical locations for meetings and source possible speakers while working with the TOPRA head office. If you think you could help and would like to be part of the WP, please contact Neil@topra.org.
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently Dr Virginia Acha, Uxbridge, UK Mr Al-Ameen Amodu, London, UK (Student) Ms Stephanie Anderson, OptumInsight, Dunda, Canada* Miss Anna Argelague Moral, Vertex Pharmaceuticals (Europe), Abdingdon, UK Miss Aurelia Arry, Novartis Pharma, Switzerland Mrs Syham Ayache, Laboratoires Galderma, Alby-sur-Cheran, France Mrs Cheryl Baker, France Dr Andreas Ballis, Covigilance, Prague, Czech Republic* Dr Raj Banwait, Coventry, UK Mrs Carolyn Belcher, Abingdon, UK Ms Bernadette Boncz, Hungary* Dr Carmen Boxler, Pullach, Germany Dr Andrea Braun-Schernag, Roche, Switzerland* Dr Fran Brewer, Slough, UK* Miss Magdalena Bujar, London, UK (Student) Ms Michelle Carpenter, Acucela, Seattle, WA, US* Ms Kee Cheung, Lonza Biologics, Slough, UK* Mrs Aparna Chiluvuri, Unique Pharma Services, Maidenhead, UK* Mrs Julia Claus, Pfizer, Sandwich, UK* Dr Valerie Codrons, Meise, Belgium* Miss Laura Convery, PPD, Cambridge, UK Mrs Camilla Costa, PPD, Cambridge, UK Dr Tan Dinh, Sunbury-on-Thames, UK Miss Harriet Dolding, Cardinal Health, Romford, UK Mrs Hiltrud Dornieden, Basel, Switzerland* Ms Marina Drosopoulou, Pfizer Group, Maidenhead, UK Miss Jacqueline Eng, OptumInsight, Dundas, Canada* Mrs Hilda Fanning, Athlone Laboratories, Roscommon, Ireland* Mr Alistair Foster, Truro, UK* Dr Sally Fram, AstraZeneca UK, Luton, UK Mr Arminder Gandhum, PPD, Cambridge, UK Ms Anna Giannakopoulou, Elpen Pharmaceuticals, Papagou, Greece
Ms Laura Hall, Diamond Biopharm, Harlow, UK Mr Craig Halverson, Issaquah, WA, US* Mr Yoseph Hawash, Luton, UK (Student) Mrs Maeve Hayden, Athlone Laboratories, Ballymurray, Ireland Mr Darryl Hill, Teva, Harlow, UK Dr James Hunt, PPD, Cambridge, UK Mrs Rebecca Hutchison, Pinner, UK Ms Kate Jacobsen, Westlake Village, CA, US (Student) Ms Ann Jones, ECO Animal Health, London, UK Miss Rina Kacha, PPD, Cambridge, UK Mr Colin Kavanagh, Arthur Cox Solicitors, Ireland Dr Jiri Kos, Biopartners, Baar, Switzerland Mrs Irene Kuhlman, Bayer, Mijdrecht, the Netherlands* Ms Susanne Lagerlund, LEO Pharma, Ballerup, Denmark Ms Gillian Latham, London, UK* Ms Ariel Le Huquet, OptumInsight, Dundas, Canada Mrs Patricia Logie, Elanco Animal Health, Basingstoke, UK* Mr Pedro Luque Sota, Reading, UK Mrs Sandra Maguire, Belfast, UK* Dr Barbara Malitschek, Montreal, Canada Dr Zinatara Manji, Hoboken, NJ, US* Ms Maite Mateo, Pharma Mar, Colmenar Viejo, Spain Mrs Kinga Mathieson, PPD, Cambridge, UK* Mr Robert McCombie, Reading, UK Miss Julie McGowan, PPD, Bellshill, UK Ms Catherine Melfi, Carmel, CA, US* Miss Josephine Mendum, PRA International, Reading, UK* Mrs Aldona Milek-Bhirangi, Norgine Pharmaceuticals, Harefield, UK Dr Stella Mokiou, Sutton, UK* Mr Emmanouil Molympakis, London, UK (Student) Dr Usfeya Muazzam, Bonn, Germany Ms Helen Naddy, Ireland (Student)
Dr Yvonne Nelson, Bristol-Myers Squibb, Uxbridge, UK Miss Harriet Nesbitt, PPD, Cambridge, UK Mrs Nicoleta Nunez Yanez, PRA International, Reading, UK Ms Maebh O’Gorman, Arthur Cox Solicitors, Ireland Mrs Polina Okhrymenko, PRA International, Ukraine Dr Suzanne O’Rourke, Mainstay Medical, Swords, Ireland* Ms Victoria Palmer, Teva, Harlow, UK Ms Belen Palop Moliner, Novartis Pharma, Basel, Switzerland* Mr Eftychios Papadogeorgakis, Actelion Pharmaceuticals, Allschwil, Switzerland Dr Elisaveta Parapiteva, TR Premier Research Germany, Bulgaria* Mr Tim Powell, Maidenhead, UK Mr Michael Prater, Cambridge, UK (Student) Mrs Noreen Qayyum, Barking, UK* Mis Elodie Radier, Amgen, Cambridge, UK* Dr Ninna Richnau, Vifor Pharma, Glattbrugg, Switzerland Dr Iris Romero-Matuschek, PRA International, Mannheim, Germany Ms Anneliese Rushworth, Brentwood, UK* Mr Steve Sanderson, Biomark Solutions, London, UK* Mr Frank Schloetz, HAL-Allergy, The Netherlands Dr Joanna Segieth, INC, Camberley, UK* Ms Arita Shah, Celgene, Berkeley Heights, NJ, US* Miss Saggi Shruti, Woking, UK Miss Tolu Sowunmi, Pudsey, UK (Student) Dr Ahila Srinvasan, Caterham, UK Ms Beverley Taylor, London, UK* Mr Mark Troughton, Richmond, UK Mr Armand Vermaire, Noord-Brabant, The Netherlands Mr Luke Webber, ProClinical, London, UK*
Jenine Willis, Greer Deal and Virginia Guellal
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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