K e e p i n g
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nov ember 2013
T h e T O P R A N e w s l e tt e r – K e e pin g m e m b e r s in T o u c h
In this issue... Reports and photos of the Annual Symposium show that the conference was both stimulating and entertaining. Take a look at some of the social highlights in the photo montage on page 3. It’s good to know that those who could not attend can catch up with session reports in December’s Regulatory Rapporteur – and that a video of the Health Technology Assessment session is available (see back page). Our regular membership column focuses on the role of the TOPRA In groups, which will interest those who would like more local networking. Sharing experiences in person is a great way to add to our development as well-rounded regulatory professionals, as demonstrated by the TOPRA In Sweden report (see back page). If you can make it to the Annual Review meeting and EGM on 27 November, you will be among the first to hear the TOPRA Board Election results (bottom left). Ishbel MacDonald, Co-editor, InTouch
A meeting of minds
A message from Patrizia Nestby, TOPRA President As you know, TOPRA’s 10th Annual Symposium took place last month – an eventful three days with a packed technical programme and many opportunities to network with colleagues and enjoy the hospitality of Portugal. The programme started with an inspiring keynote speech delivered by the highly respected Dr André Broekmans – a former regulator and leading industry expert – who provided us with a glimpse into the future; the ‘Quo Vadis’ of our profession. This was complemented at the end of the Symposium by the highly esteemed regulator Dr Ian Hudson, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), who reflected on the successes in the current regulatory framework along with aspects that need improvement. Both speeches proved interesting and thought-provoking. The Symposium was truly a meeting of peers, discussion and insight; with a particular focus on the proposals for the clinical trial regulation, the new EU medical device legislation, clinical development of combination products and
challenges and opportunities associated with social media. The medical device and veterinary symposia were well attended, as well as the several parallel tracks including an engaged and buzzing session on professional development in regulatory affairs. This year’s event delivered what is expected of the Symposium: opportunities for learning, sharing experiences, debate on hot topics and new developments, networking, getting to know each other as well as enjoying the local flavours of the host country. The success of this year’s Symposium would not have been possible without the enthusiastic involvement in developing the programme by Infarmed; the logistical support delivered by the TOPRA office staff; and of course, the many volunteers. I’d like to say a particular thank you to the volunteers who, without any form of
financial compensation and on top of their already busy day jobs, provide a major contribution to the success of the TOPRA Annual Symposium and many other TOPRA events. What is driving these volunteers is a passion for the profession and a strong belief that this is the way to promote excellence. The involvement of these many volunteers is not always visible but it is indispensable, and for this reason I’d like to sincerely thank you all. TOPRA would not exist without your hard work and dedication! As a postscript, if you were unable to attend the Symposium, you will be able to catch up by reading the session reports in the December edition of our journal, Regulatory Rapporteur. There is also the opportunity to purchase access to a video of the HTA session (for details see page 4).
ANNUAL REVIEW MEETING AND egm All members are welcome to attend the Annual Review Meeting and EGM at 4.30pm on 27 November, 2013 at the Institute of Directors in London. The meeting is an important opportunity for you to hear about TOPRA’s activities over the past year – and find out the results of the TOPRA Board Elections, which concluded on 20 November. We are also asking our members to approve some minor amendments to TOPRA’s Memorandum and Articles of Association as part of a brief Extraordinary General Meeting (EGM). If you are unable to attend, but would like to vote on any matters that arise at the meeting, you can appoint another member to act as your proxy for this year only. Go to www.topra.org/2013-proxy-form
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MEMBERSHIP NEWS
Reaching out in local networks In this month’s column, Head of Membership Duncan Judd looks at the role of the TOPRA In groups This month I’d like to bring you up-to-speed with our successful local networking groups – TOPRA In groups. The aim of the TOPRA In groups is to: ● Develop a local TOPRA networking arm in individual countries for meetings and discussion ● Support the TOPRA members living and working in a country and increase their network of regulatory professionals ● Work cooperatively with other not-forprofit or government organisations and relevant academic institutions. We now have very active TOPRA In groups based in North America, Ireland, Sweden, Austria and Switzerland. Each group holds face-to-face meetings in their country. The prime objective for TOPRA In members is to meet up with local regulatory colleagues in an informal environment. Each meeting includes a regulatory focus to help start the discussions
and to enable sharing of experiences, which helps attendees gain insight into industry issues from their peers. It also shares best practice which can assist them in their regulatory roles. One of the most enjoyable aspects for TOPRA In members is that the meetings take place in a social environment, so they are an opportunity to relax in the company of colleagues. This ethos has helped TOPRA In groups evolve into tight-knit communities of members who share regulatory experiences, knowledge of healthcare, pharmaceutical and medical device development and social discussions. The most recent TOPRA In meetings have been based in Ireland, Switzerland and Sweden where members have discussed various topics and in the case of the Swiss meeting, were joined by the government agency Swissmedic. The
Online learning with TOPRA
Improving access to regulatory updates across the globe The University of Wisconsin and TOPRA recently launched a new webinar series entitled ‘An Overview of US and EU Regulatory Processes’, the aim of which is to provide a foundational overview of regulatory procedures in the US and EU, and introduce the framework and structure of regulatory and pharmacovigilance procedures in two key regions of the world. Over 70 people logged in to the first webinar on ‘The US Regulatory Process’ that took place on 17 October 2013. Participants came from across the US, Europe and South East Asia, ensuring it was a truly global event. For the second webinar in the series on 24 October, covering ‘The
European Regulatory Process’, some 80+ delegates, again from all over the world, registered. The webinars are ideal for life sciences professionals who work within the drug development lifecycle and want to learn more about global regulatory and pharmacovigilance processes. The webinars start at 10:00 am EST and each webinar lasts 60 minutes. They are followed by an open Q&A session. For more information, visit www.topra.org/useuwebinar3 for the EU Pharmacovigilance webinar and www.topra.org/useuwebinar4 for the webinar on The US Pharmacovigilance Requirements.
meetings in Ireland and Sweden were also held in the offices of their agencies. Feedback from TOPRA In meetings often appears in InTouch, just take a look at the latest report from TOPRA In Sweden on the back page. I am looking forward to supporting these activities further with the new membership database and website early next year. The new website will enable members to engage and interact with others in the same networks, provide instant messaging for Q&As, access to meeting dates, downloadable information and minutes, and will allow members to join any of the available networks by simply updating their details. If you want to know more about TOPRA In groups and see if there is a local network near you go to www.topra.org/topra-in or please email me with your questions at duncan@topra.org.
Become a
regulatory doctor! In September’s edition of InTouch we announced that the contract for the TOPRA PhD in Regulatory Affairs had been signed with Cardiff University. The PhD programme is a researchbased degree which can be studied part time over a five-year period, or three years full time, and is open to anyone who has completed a previous MSc. If you would like more information or to apply to undertake the PhD, please contact kay@topra.org who will be able to provide you with more details.
The 10th TOPRA Annual
Symposium2013 Highlights from Lisbon in pictures!
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1 Eliza Okoria (right) was delighted to win a Kindle in the Symposium Prize Draw. 2 Infarmed’s Helder Mota Philipe (left) passes on the TOPRA flag to Greet Musch (right) from the Belgian Agency, who will co-host next year’s Symposium. 3 A panoramic view of Lisbon from the top floor of the venue.
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4 A packed audience at the Main Symposium. 5 The networking reception was enjoyed by all. 6/7 The taste of Portugal and singing from traditional Fado singers proved to be a highlight. 8 TOPRA staff were always on hand to answer delegates’ questions. 9 Delegates found plenty of time for study and and socialising. 10 Congratulations to Aleksandra Domzalska (pictured) from the University of Wolverhampton in the UK, who won the first prize in our student poster competition. The second prize went to Elena Fasniuc, Universitatea Stefan cel Mare Suceava, Romania; and third prize to Sara Soares, University of Aveiro, Portugal.
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N OV EM BER 2013
InTouch Editors: Jenine Willis, Greer Deal and Ishbel MacDonald
Editorial support:
TOPRA In Sweden
Rachel Cook
How to contact InTouch InTouch welcomes contributions from TOPRA members.
Pharmacovigilance hotly debated
TOPRA in Sweden arranged a networking meeting on pharmacovigilance on 22 October at the Medical Products Agency (MPA) in Uppsala, Sweden. There was an excellent turnout with 77 attendees, who listened avidly to presentations on: ● Risk
minimisation/RMP/PSUR and the MPA experience by Qun-Ying Yue, Senior expert in pharmacovigilance at the MPA and member of the PRAC. ● Good Pharmacovigilance Practice (GVP) modules from a regulatory perspective by Margareta Svensson, Unit Manager, Drug Safety, Trial Form Support (TFS) in Lund, Sweden. ● Pharmacovigilance Risk Assessment Committee (PRAC), by Ulla Wändel Liminga, Scientific Director for Pharmacology and Toxicology at the MPA and alternate member of the PRAC. The topics were a successful mix of various aspects of the new pharmacovigilance legislation, with a great deal of interest from the audience. As this is a broad subject for discussion, another meeting is already planned. Vera Franzén
An exciting opportunity for those who missed the TOPRA Annual Symposium… The session on HTA (Health Technology Assessment), rated ‘outstanding’ by many of the delegates, is now available to watch online. You can watch an excerpt for free before deciding to purchase the whole session. The session is essential viewing for everyone working in regulatory affairs. It provides a comprehensive introduction to HTA and also discusses current developments such as HEOR submissions and meetings. The speakers are: Stefan Holmstrom, Director HEOR, Astellas, the Netherlands and Mira Pavlovic, Deputy Director for HTA, HAS, France. Visit www.topra.org for more information.
NEWTOPRAMEMBERS
If you would like to contribute to the newsletter, or find out about deadlines, please contact Rachel Cook (rachel@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 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 Mr Glauco Amato, Maynooth, Ireland* Ms Melanie Anderson, Consultant, Triveritas Ltd, Brampton, UK* Mr Warwick Bryant, CMC Regulatory Associate, Clinical Network Services, Toowong, Australia* Mr Greg Carr, Regulatory CMC Manager, AstraZeneca Pharmaceuticals, Macclesfield, UK* Mr Sushil Chaudhari, Regulatory Consultant, Uxbridge, UK Ms Nicole D’auteuil, Vice President, Billerica, USA* Miss Jaspreet Dhillon, Southall, UK (Student) Mr Rasmus Engelbrecht, Senior Regulatory Intelligence Manager, Novo Nordisk A/S, Soborg, Denmark*
Dr Carmen Garcia Carbonell, RA Manager, Laboratorios LETI S.L., Madrid, Spain* Mrs Ann-Kristin Gellerbring, Senior Life Science Professional, Sollentuna, Sweden* Dr Nicola Gover, Regulatory Associate, Reckitt Benckiser Healthcare (UK) Ltd, Hull, UK* Miss Emily Haggerty, Torpoint, UK (Student) Dr Erika Hauck Eckel, Regional Manager for Latin America, F. Hoffmann-La Roche Ltd, Switzerland* Mrs Sam Hoffman, Biddulph, UK* Mrs Nico Fangyu Kan, Regulatory Affairs Manager, Boehringer Ingelheim RCV GmbH & Co KG, Austria* Dr Katarzyna Landis, Aarau, Switzerland
Dr Peter Landvall, CEO, Director QA/RA, Akersberga, Sweden Ms Anne Lecocq, Editorial Manager Thomson Reuters (Scientific), Paris, France Dr Matthieu Levee, Senior Manager, Biogen Idec Ltd, Maidenhead, UK* Mrs Loretta Lydon O’Toole, European Regulatory Liaison, Ireland Ms Petra Matt, Project Manager, NDA Advisory Services, Leatherhead, UK Dr Sybille Meyer, Regulatory Affairs Manager, Gladbeck, Germany Ms Cora Morley, Lucan, Ireland Mrs Marie-Armelle Mouret, Regulatory Affairs Director, Gambro, Colombes, France*
Dr David Neasham, Director & Senior Research Scientist, London, UK* Mr Jack O’Reilly, Regulatory Affairs Officer and Deputy QPPV, DDD Ltd, Watford, UK* Mr Devesh Patel, London, UK* Mrs Susan Scanlan, Welshpool, UK* Dr Amanda Shipman, Associate Director, Eden Biodesign, Liverpool, UK Dr Alejandro Silva, Janssen Cilag S.A, Pharmacovigilance Manager, Colombia Ms Mary Sinnott, Regulatory Consultant, GABA International, Scweiz, Switzerland* Ms Halina Sztabinska-Koncka, Regulatory Affairs Director, Polpharma SA, Warsaw, Poland Dr Hans van Bronswijk, Vice President, PAREXEL, Uxbridge, 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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