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J un e 2013
T he T O P R A N ewsletter – K eeping members in T ouch
In this issue... Many exciting initiatives are taking place at TOPRA. We now have our first Head of Membership who, along with the team, is looking at ways to restructure the current membership process in time for the renewals in 2014. The TOPRA In groups are clearly doing well and growing, and then there’s the increasing number of links with other organisations. I don’t know about you, but I can definitely see the benefit of being a TOPRA member – if nothing else, it’s a fantastic support network. Last but not least! Don’t forget the closing date for registering nominations for the TOPRA Awards is 20 June, so please nominate your regulatory star and give them the recognition they deserve. Greer Deal, co-editor
Preparing for Lisbon
A message from Patrizia Nestby, TOPRA President Having participated in the TOPRA Annual Symposium Working Party for many years, this annual meeting is particularly close to my heart. It is our cornerstone meeting, and this year’s preparations are well underway. The Annual Symposium not only provides a comprehensive review of the hot topics in regulatory affairs, it is a coming together of the regulatory community providing ample opportunity for networking with peers. Each year, the Symposium is held in one of the EU member states and the working party collaborates with the national regulatory agency to prepare the programme. In addition, the event is inspired by the local flavour and passions of the country in which it is held. This year’s Annual Symposium will be a celebratory one as it will be the tenth since TOPRA was launched. The meeting will take place in Lisbon, Portugal, on 16–18 October. It is organised in conjunction with Infarmed, the Portuguese Authority of Medicines and Health Products. Under the chairmanship of Craig McCarthy, the Symposium Working Party has prepared a particularly compelling programme with the enthusiastic support from Vice President of Infarmed, Helder Mota Filipe, Maria Morais (Adviser of the Executive Board International Relations and Cooperation, Infarmed) and their Infarmed colleagues. In addition, June Raine (Chair PRAC, MHRA,
UK), Tomas Salmonson (Chair CHMP, MPA, Sweden) and Peter Bachmann (Chair CMD(h), BfArM, Germany) have been involved as special advisers to the Working Party.
Parallel Symposia
As is traditionally the case, the main Symposium is on Pharmaceutical Medicines with two parallel symposia: Medical Devices on 16–17 October with Infarmed and the Veterinary symposium on 17–18 October with the cooperation of the Portuguese veterinary agency DGAV (Direção Geral de
Alimentação e Veterinária). With a great number of highly respected speakers from all over the world representing regulatory agencies, the European Commission and industry, this year’s Symposium promises to be the must-attend event of the year. Make sure that you don’t miss the Early Bird booking registration which is applicable until the end of this month (30 June). The preliminary programme and booking forms are available at www.toprasymposium.org.
TOPRA Awards
nter E The closing date for this year’s OW nominations is 20 June. N Go to www.regulatoryaffairsawards.org now Last chance to register
to register your interest and get further information.
With seven categories to choose from you are sure to find the right category for your regulatory star: ● ● ● ●
Communication Education Horizon Innovation
Inspiration ● Support ● Life Time Achievement ●
For more information or advice email awards@topra.org or call Rachel on +44 (0)20 7510 2560.
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TOPRA STUDENTS From undergraduates to seasoned professionals Student membership of TOPRA has been steadily growing since this membership category was introduced in 2010. We now have 144 student members who are about to start on the path of a rewarding and challenging career in regulatory affairs. TOPRA reaches out to potential student members in a number of ways. Angela Stokes, Chair of the Professionalism Committee, explains: ‘TOPRA continues to visit universities and colleges to promote careers in regulatory affairs. While doing so we are particularly careful to explain that graduate jobs in the industry are currently at a premium, so we suggest routes into regulatory affairs which show an employer that a candidate has useful transferable skills such as clinical trial management, GMP/GCP experience, etc. ‘Our job is to help new graduates take opportunities which will open the door to a career in the industry and show them that just because there is no “off the peg” job advertised in regulatory affairs, this does not mean that they cannot aspire to joining the profession by the back door,’ she says. Many TOPRA volunteers have links with their local universities and are happy to share their experiences with students. If you have been invited to do this, we have a presentation aimed at students, that you can use. Just contact careers@topra.org and we can send it to you.
Christopher Bailey meets students interested in regulatory affairs
Christopher Bailey, Regulatory Intelligence and Training Manager at TOPRA, regularly gives talks at universities and recently attended a careers fair at Oxford Brookes University (see picture). He says that it is often the vast changes that have taken place in regulatory practices to the present day which are most appealing to those considering a regulatory career, serving to reinforce the importance of the industry in raising and maintaining standards.
Qualifying for the future Congratulations to Dr Annette Barry (pictured below) whose TOPRA MSc Regulatory Affairs degree was confirmed at the graduation ceremony held at the Millennium Centre in Cardiff on 2 May. Annette said, ‘My experience with the MSc in Regulatory Affairs was a very positive one. While it was hard work, it was very worthwhile and developed my expertise from a technical and strategic standpoint.’ If you are interested in undertaking this MSc, which is now validated by the University of Hertfordshire, please contact Kay Wood at kay@topra.org or telephone 0207 510 2569.
EXCITING DEVELOPMENTS IN TOPRA MEMBERSHIP SERVICES
Dr Annette Barry
Plans are underway to restructure the current TOPRA membership process, creating new opportunities for membership and progression pathways in order for members to get the most out of their association with TOPRA. These plans will ensure the development of membership communications, with a clear message of how belonging to TOPRA can benefit both your career and the regulatory affairs profession. Initiatives to expand the TOPRA In networks are also in development, with a view to European members becoming more involved and able to engage with their local network. A key part of these initiatives has been the appointment of a Head of Membership to take all these activities forward...
...Welcome to the TOPRA team, Duncan!
Duncan Judd
Duncan Judd is the new Head of Membership, and he joined TOPRA last month. His priority is now to develop membership strategy and initiatives within the organisation. Duncan has worked in membership management for more than 10 years, most recently as Membership Manager at the Institute for Learning. He brings a wealth of experience to the role and insists that working with members on a regular basis is the key to achieving an engaged and active membership, and creating an effective strategy to develop membership communications and services is essential to maintaining that engagement. ‘Member input is an effective way to gain knowledge and can offer a vital insight into differing perspectives. I look forward to gaining the views of our members throughout Europe and I hope to be sending out a member survey very soon,’ he says. If you would like to find out more about TOPRA membership or you have any ideas you would like to share, please contact duncan@topra.org.
J u n e 2013
T he TOPR A Newsletter – Keeping members in Touch
News From the Board... The North America team plans activities for the upcoming year.
Annual get-together in the US On 13 May, the TOPRA North America Leadership Team (NALT) had its annual face-to-face meeting in New Jersey. Ten US and Canadian colleagues were able to join in person while others joined via teleconference. TOPRA personnel from the London office also attended part of the meeting via phone. Various topics were discussed including the planning of 2013–2014 TOPRA North America events, such as the ‘Essentials of EU Regulatory Affairs’ courses, upcoming webcast programmes, as well as the North America focus November issue of the Regulatory Rapporteur. As you will see from the story and picture below, we celebrated Christopher Griffett’s retirement – after a long career in regulatory affairs and many decades of volunteering for TOPRA – with a cake and a gift from the local team and TOPRA.
Thank you Chris! Chris Griffett has been a member of our organisation since 1979 and during that time has held a number of important positions including Chairman, leader of various successful working parties and a found and leading light of TOPRA’s North America leadership group. In his regulatory career he started in the UK working for companies including Warner Lambert and AstraZeneca, but moved to the US when his responsibilities became more global. He has held senior roles at Schering Plough, Pfizer and Sanofi Aventis and has just retired as VP of Regulatory Affairs, at Celgene. Over the years Chris has supported numerous pharmaceutical trade association activities, such as EFPIA and PhRMA. Happily, Chris will continue as a Fellow of TOPRA, an active participant in our North American activities and a member of our elite judging panel for the Regulatory Affairs Awards. Chris Griffett cuts the cake!
TOPRA Board members met up for their bi-monthly face-to-face meeting in May. It was a great opportunity for our two newest members, Ljiljana Markuš Cizelj and Christine Mayer-Nicolai, to be present at the TOPRA offices and participate in the discussions. Judith Creba, who is an ‘observer’ to the Board, dialed in from Switzerland. It was also the first Board meeting for our new Head of Membership, Duncan Judd.
Investing for the future Two major investment projects were discussed. The first is the updating of the TOPRA membership management system to improve the way in which TOPRA and its members can interact. This project aims to complete by the end of the year so that it can be used for the 2014 renewals. The second investment that the Board is considering relates to the provision of e-learning tools by TOPRA. There is currently quite a bit available via the TOPRA website and this needs to be communicated more to members. A strategy for further e-learning provision is under development by the Board in conjunction with staff members. The other main topics for discussion were: ● On the finance side, the management accounts for the first quarter of 2013 showed that TOPRA is running slightly ahead of budget so far. ● The Board considered how TOPRA can best make
the valuable resource that is represented by the MSc dissertations available to members as a means of adding to their personal professional learning. ● An update on the progress of the 2013 Awards was given –
see elsewhere in this edition of InTouch ● The Board noted a number of developments in our
relationships with other organisations, including national agencies, course providers, IMI, other regulatory associations and trade associations.
Advisory Council meeting Following the Board meeting, the Spring 2013 Advisory Council meeting was held. The AC helps the Board by giving an external perspective on our activities and advice on future direction. At this meeting there was a helpful discussion on the ways in which TOPRA can act as an independent platform for debate and how the current political and economic environment impacts on TOPRA’s role and activities. Members are welcome to input ideas or observations on any of these above discussion points by emailing lynda@topra.org.
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TO P R A I N U P DAT E S
J u n e 2013
InTouch Editors: Jenine Willis and Greer Deal
How to contact InTouch MPA participants 16 April 2013
Sweden goes from strength to strength The sixth TOPRA In Sweden Networking and Regulatory Update meeting took place at the Medical Products Agency in Uppsala last month. It was an ideal opportunity to hear the latest about TOPRA as well as the latest news on pharmaceuticals from Christer Backman, MPA, and on medical devices from Helena Dzojic, MPA. Susanne Baltzer talked about the new Innovation Office at MPA to support life sciences. The evening was also a perfect opportunity for the 51 participants to network with colleagues from the regulatory environment in a relaxed and sociable setting. For more information email toprainsweden@topra.org Margareth Jorvid (Sweden)
TO P R A I N U P DAT E S
Webinar attracts members from Austria, Italy and Spain Members from the three TOPRA In... groups dialled in and enjoyed two interesting presentations on the following topics:
1) Scientific Advice/Protocol Assistance
2) Combination products from an RA point of view
After a short introduction, Professor Paolo Biffignandi, a former TOPRA President, gave an informative talk about Scientific Advice (SA)/Protocol Assistance, including the importance of SA in the pre-submission phase, particularly if the available guidance does not provide the answers sought in the public domain. Dr Martina Hoeth then outlined the exciting world of medicinal product/medical device combination products from the RA point of view. Her slides were very helpful to understand the complexity of combination products and the related requirements. Both presentations are on the TOPRA website at www.topra.org/topra-austria. This second joint TOPRA In event was well received by all participants. We shared our knowledge and in addition this event allowed the exchange of experiences between RA professionals in different countries. We are looking forward to welcoming more and more participants to our upcoming events in Austria, Italy and Spain (go to www.topra.org/topra-in for further details). Antonia Orsi (Italy), Collette Beglin (Spain); and Elke Hofer-Litzlbauer (Austria)
AUSTRIA
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
I T A L Y
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NEWTOPRAMEMBERS
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 Ms Tanya Konovalenko, Global Category Lead, Novartis Consumer Health SA, Nyon, Canada* Mr Clive Burge, Head, Regulatory Affairs (North America), Vifor Pharma - Aspreva International, Victoria, Canada* Mrs Victoria Hall, Global Regulatory Affairs Associate, Reckitt Benckiser, Hull, UK* Ms Sonja Welterlin, Regulatory Affairs Specialist, Novartis Animal Health, Basel, Switzerland Mr David Lawson, Regulatory Manager, CN Creative, Manchester, UK* Mrs Venkata Sreelakshmi Paruchuru, Weston-super-Mare, UK (Student) Mrs Paula Morgan, Director, Regulatory Affairs, US Mr Carl Brooker, Regulatory Project Manager, Letchworth Garden City, UK* Miss Louise Coldrick, Regulatory Leader, Cardiff, UK*
Dr Gordon Daly, Regulatory Affairs Manager, Johnson & Johnson, High Wycombe, UK Dr Jan Smeets, Director, Regulatory Affairs, DSM Sinochem Pharmaceuticals, The Netherlands Ms Valentina Natoli, Regulatory Affairs & Pharmacovigilance Officer, Stallergenes Italia, Milano, Italy* Ms Carolyn Beeden, General Manager, Woodley BioReg, Huddersfield, UK* Mr Shankar Menon, Associate Consultant, Parexel Consulting, Uxbridge, UK Miss Sinead Ewart, Mitcham, UK (Student) Mr Imran Akhtar, Regulatory Consultant, Thornton Heath, UK* Ms Kriti Gautam, London, UK (Student) Mr Timothy Sheehan, Wellington Point, Queensland, Australia (Student) Ms Amanda Finley, Collinsville, US (Student)
Mr Guiseppe De Marco, Associate Regulatory Affairs, Amgen, Cambridge, UK Dr Shweta Chavan, Post Doctoral Research Assistant, Regius Inc, Swindon, UK* Dr Anna Ramirez-Soriano, Spain Mr Oliver O’Connell, Liverpool (Student) Ms Nancy Pire-Smerkanich, Collegeville, US (Student) Dr Shane Ratcliffe, Product Development Scientist, Tagerine Holdings, Lytham St Annes, UK Mrs Monica Bergvall, London, UK Mr Luke Maishman, Cambridge, UK (Student) Dr Johannes van Gelderen, Senior Regulatory Project Manager, Shire, Switzerland* Dr Louise Slater, Senior Regulatory Associate, Allergan, Marlow, UK* Mr Patrick Reynolds, Research Consultant, Sharpstream Life Sciences, London, 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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