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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... This month is a busy month for TOPRA. The winners of the TOPRA Regulatory Affairs Awards 2012 will be announced on 28 November. It’s your last chance to book your place at the Awards – and the Inaugural TOPRA Annual lecture (see page 4). Don’t forget the EMA Annual Review Meeting starts the following day on 29 November. If you weren’t able to attend this year’s Symposium you can get a flavour of the social side of this event on pages 2 and 3. The new TOPRA Board was announced during the Annual Review meeting (see page 3). I’d like to thank David Jefferys for all his dedication and for keeping us entertained with his thought-provoking editorials. This latest one relates to early access and adaptive licensing, the latter probably new to many of us. The TOPRA In groups continue to develop. See what TOPRA In Sweden and Denmark have been up to on page 4. Catch up also with what your colleagues are doing such as charity or work changes on the back page. Virginia Guellal
N ov em ber 2012
Early access and adaptive licensing A message from David Jefferys, TOPRA President 2011-2012 As Regulatory Affairs professionals we have a common interest with patient groups, to ensure that safe and effective medicines are made available at the earliest opportunity. Therefore, this month I am looking at another hot topic in 2012, namely early access to medicines and adaptive licensing. Early access schemes have been introduced for two reasons. The first is to circumvent delays in access resulting from the lengthy reimbursement and pricing procedures in most European markets. The second is to shorten the time interval between the completion of the clinical studies and the issuance of the authorisation. The MHRA in the UK has recently put forward such a procedure for consultation. These proposals bring a welcome addition to the tools available to companies, but will probably only be used in special circumstances and will not be applicable to many projects. The current draft of the EU Commission’s Transparency Directive, which is under discussion in the Parliament and the Council, sets tighter timetables for the stages of pricing and reimbursement. All this helps. Adaptive licensing is a separate topic, although frequently confused with early access. It is interesting to see how much has already changed. There has been considerable innovation in the design of clinical programmes, with seamless transition from Phase IIb into some Phase III programmes.
We have seen the introduction of population pharmacokinetics, enrichment designs, multiple parallel arms and use of forced titration and back titration within programmes. The renewed interest in and selective use of Bayesian/ probability density approach is a further tool which I think needs to be used more widely. Arguably, the provision for conditional approvals within European legislation has not been interpreted and taken up as was intended by the Parliament. Focus on real-world data There are many think tanks considering how additional changes could be brought forward. Ideas include staggered/rolling evaluation, moving the control point to early in the lifecycle with greater reliance on real-world data and patient randomisation within real-life usage protocols. These are interesting debates but frequently hit the problem of whether you can have adaptive early licensing without early adaptive reimbursement. In the field of oncology the position is changing rapidly with the identification of powerful new biomarkers which can be validated early in development and used to recruit tightly defined groups of patients in whom there will
be a large ‘effect size’ of the medicine. As a consequence, we are likely to see full approvals granted for selected indications on much smaller numbers of patients, because the effect size will be such that small numbers will give a strongly significant and convincing result. Perhaps what we need is not adaptive licensing but a more open and adaptive approach by regulators working with patient groups, industry and academics. There are encouraging signs that this is beginning to take place as we heard during the TOPRA Annual Symposium in Dublin. As Regulatory Affairs professionals we need to be engaged in these debates. We have a rich store of knowledge and experience to contribute. The TOPRA Board wants to ensure that we are engaged selectively in these and other such key discussions which will profoundly affect the Regulatory Affairs profession and in which we can offer a unique, non-partisan and influential voice. David Jefferys President of TOPRA 2011-12
For information on the new TOPRA Board, see page 5.
TOPRA invites you to ... ... join in our social media communities TOPRA is keen to encourage members to network virtually via our public TOPRA LinkedIn group and our SPIN eGroups, which are for TOPRA members only. We have produced some guidelines on participating in such networks which we hope will be helpful if you are unsure of how to make the most of social media. For more information email erik@topra.org.
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Successful symposium The TOPRA Annual Symposium last month was a great success with the highest overall attendance ever! Around 600 regulatory professionals joined in the discussions at University College Dublin (Main Symposium and SME day) and Stillorgan Park Hotel (the venue for the Veterinary and Medical Device Symposia).
Top inset: Irish dancers at the Taste of Ireland networking reception. Below: Delegates mingle in the Exhibition. Inset right: The IMB hands over the TOPRA flag to Infarmed.
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The Irish Medicines Board worked with the TOPRA team to create a programme that covered a wide range of topics, with the feedback showing the subjects of access to medicines and patient information being most popular. The IMB special sessions, on topics of particular interest to the local industry were very well received. The timing was just right for the Medical Device Sector as the proposal for a new Regulation had been issued less than a week earlier. Manfred Kohler from the European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2), discussed the proposed legislation and answered some questions. At the end of the meeting, the TOPRA Symposium flag, which had been flying outside the University, was handed over by Ann O’Connor from the IMB to Helder Mota Filipe of Infarmed, the Portuguese Agency, which will be partnering with TOPRA to deliver the 2013 event in Lisbon – watch out for more information in the coming months!
T h e TOPR A N e wsle tt er – K eepi ng memb e r s in To uc h
N ov em b e r 2012
new pic -guillam
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Congratulations to our prize winners Every year during the Symposium, delegates have the opportunity to enter into a prize draw by visiting all the exhibition stands and getting a prize draw card stamped. This year’s winners are:
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First prize – One 2-day delegate ticket for the EMA Annual Review Meeting in London, on 29–30 November 2012: Cheryll Nattress, Associate Director, Janssen Research & Development
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Second prize – Free TOPRA membership for one year, starting 1 January 2013, expiring 31 December 2013: Charlotte Lewerth, Head of Regulatory Affairs, Recipharm AB Third prize – £25 gift voucher: Susan Cameron-Laxton, VP European Regulatory Affairs, Vertex Pharmaceuticals
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(1) The TOPRA Board reports at the Annual Meeting. This year’s TOP Team is the Veterinary Courses Working Party: (2) Ray Harding; (3) Guillaume Agède; (4) Melanie Lievers; (5) Rhona Banks; and (6) Rick Clayton.
Fourth prize – An Irish Goody Bag, consisting of a variety of typically Irish products: John Fletcher, Regulatory Affairs Manager, Janssen-Cilag Ltd In addition, we also offered the opportunity for those who completed a membership survey at the Symposium to be entered in a draw to win a Kindle eReader. The winner of this was Regina Joyce, Regulatory Affairs Manager, Meda Health Sales Ireland Ltd.
Annual Review Meeting report The TOPRA Annual Review meeting was held in Dublin on 2 October. This was a chance for TOPRA members and guests to hear about all the activities of their organisation over the past 12 months. The slides presented are now available for all members on the TOPRA website (https://www.topra.org/annual-review-meeting-report%20) and all members should have received an electronic copy of the Annual Review document, which is also available on the website. If you would like a hard copy of the report please email lynda@topra.org. It is an attractive and useful way to make colleagues and senior management more aware of TOPRA and understand why you are a member! During the Annual Review meeting, Honorary Life Membership awards were announced and Peter Bachmann (BfArM) was presented with his certificate. A representative of Cogent also presented the certificate showing TOPRA to be an accredited Centre of Excellence for Regulatory Training to the President. The TOPRA TOP Team for the year was the Veterinary Courses Working Party and Chair Ray Harding accepted for the team at the Annual Meeting. Individual team members were presented with their certificates at the Veterinary Symposium the next day.
(L–R) Peter Bachmann receives his Honorary Life Membership certificate; David Jefferys accepts a Centre of Excellence award from Cogent; (below) Ann O’Connor, Pat O’Mahoney and Lynda Wight
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Awards Update 2012 Join us in celebrating excellence!
It’s your last chance to book your place at the Awards Ceremony on 28 November and help us celebrate the achievements of all the short-listed nominees. Be one of the first to find out who the winners are at the Awards Dinner at the Radisson Blu Portman in London. As part of your ticket price, you are invited to attend the inaugural TOPRA Annual Lecture, at which Sir Michael Rawlins will take a controversial and thought-provoking look at Regulatory Affairs. Find out first-hand why he believes understanding the centralised procedure is no longer enough for RA professionals. But what will be the key skills for a regulatory scientist in the future? Come and hear Sir Michael’s forthright opinions on how the regulatory profession should be developing.
Go to www.regulatoryaffairsawards.org for more details about the Awards. You can book your place at the Awards Dinner and Annual Lecture online at https://www.topra.org/awards-2012-bf. If you have any questions email awards@topra.org.
The Shortlist for this year’s TOPRA Regulatory Affairs Awards is: INSPIRATION
COMMUNICATION
Hilde Boone (EMA) and Janice Soreth (FDA) Jonathan Trethowan (TRAC Services) Kim Wharton (Regulis Consulting)
HORIZON Jenny Gray (Regulis Consulting) Sheetal Mudda (MicroLabs) Eileen Ryan (Acorn Regulatory Consultancy Services)
INNOVATION Alan Colley and Alex Yates (Amgen) Mike May (TRAC Services) Gerald Thompson (Boots)
Gemma Robinson (Acorn Regulatory Consultancy Services) Joanna Schmidt (Abbott) Henrietta Ukwu (PPD)
EDUCATION Sue Harris (MHRA) Frances Richmond (University of Southern California) Nancy Smerkanich (Octagon Research Solutions)
SUPPORT SME Office at EMA (Melanie Carr) Regulis Consulting (Amy Whyte) Samarind (Miranda Pothiawala)
LIFE TIME ACHIEVEMENT – the winner will be announced on the night. Thank you to our sponsors
RMS samarind pharmaceutical software solutions
TOPRA in Sweden and Denmark Our regulatory networking and information meeting for TOPRA in Sweden/Denmark held its first local meeting at Medeon in Malmö, Sweden on 12 September.
DENMARK
The meeting attracted 24 participants from South Sweden and Denmark, who listened to Steffen Thirstrup’s presentation on the work at the newly formed Danish Health and Medicines Authority as well as some news on the Pharmaceutical legislation and the practical work that follows. Margareth Jorvid, Methra Uppsala, LSM group talked about combination products (drug/device), similarities and differences in the pharmaceutical and device legislation and the regulatory processes for a product to reach the market. Sofia Faraasen, BSI, talked about the work of a notified body and how this may change with the new European device legislation. A time for Q&A followed and the speakers were joined by Ellen Jespersen, DHMA, who has many years’ experience in regulating devices in Denmark and EU. The evening event also gave the opportunity to network with regulatory colleagues in the area.
T h e TOPR A N e wsle tt er – K eepi ng memb e r s in To uc h
News New Board announced
Over the summer all members of TOPRA were invited to nominate candidates for the Board and to vote in the election. Thank you to everyone who took the time to do this.
Aine Kane was confirmed as the successful candidate in the election for EU Representative. This, and the overall make up of the new Board, including new President Patrizia Nestby, the new President-Elect, Jonathan Trethowan and the new North America representative, Patricia Duchene, was presented at the Annual Meeting in accordance with our constitution. The formal transfer of Board responsibilities will take place at the November Board meeting, which is the final meeting of 2012. Members of the new and old Board will be present and it will be an ideal opportunity to reflect on the past year, pass over what has been learned, agree the strategy and set the budget for the coming year. The complete incoming Board is shown in the table below. We thank David Jefferys for his excellent leadership over the past year and also to Zubair Hussain and Monique Garrett as they step down at the end of their terms of office. Both have been enthusiastic supporters of TOPRA and will continue to be active and involved members. Sharp-eyed members will spot that we are one Director down, as Jonathan Trethowan has moved from Director to PresidentElect and so one of the first jobs of the new Board will be to consider a ‘co-option’ to fill this vacancy until the next election. POSITION
INCOMING
PRESIDENT
Patrizia Nestby (Netherlands)
PAST PRESIDENT
David Jefferys (UK)
PRESIDENT-ELECT
Jonathan Trethowan (UK)
Regional DIRECTOR (Europe)
Aine Kane (UK)
N ov em b e r 2012
TOPRA Staff
Who’sWho A series in which InTouch profiles members of TOPRA’s office team
Erik Smit – Marketing and Communications Manager In addition to marketing TOPRA’s wide range of educational courses and current awareness events, Erik is responsible for helping to meet the Board’s objectives to grow membership, explore additional services and further build TOPRA’s external profile. Erik has been instrumental in developing TOPRA’s exhibition business and building links with a wide range of member and non-member Regulatory Affairs professionals through social media, particularly LinkedIn. Before TOPRA, Erik was a marketing executive with the Sector Skills Council for Science and Engineering Manufacturing Technologies. Previously, he was marketing and development executive for Miller Freeman, publishers of Food Manufacture and Manufacturing Chemist. Erik studied International Management at the Arnhem Business School, and he has a Postgraduate Diploma in Marketing from Kingston Business School. You should contact Erik regarding exhibitions and eNews. Just email erik@topra.org.
Regional DIRECTOR (North America) Patricia Duchene (US) DIRECTORS
Niamh Lawler-Turner (Ireland) Sarah Roberts (UK) Steve Brookes (UK)
Medicines promotion meeting On 7 December, the Pharmaceutical Medicine and Research Section of the Royal Society of Medicine is running a meeting on ‘Promoting medicines – compliance and the law’. Speakers include Heather Simmonds, Director, Prescription Medicines Code of Practice Authority, and Dr Lincoln Tsang, Partner, Arnold & Porter LLP (TBC). For a full programme and to book online: http://www.rsm.ac.uk/academ/pmd01.php.
Need a meeting room in London? Then why not hire the meeting room at TOPRA Headquarters in Docklands, just a five-minute walk from Crossharbour DLR station, and ten minutes from Canary Wharf station? You can hire the room for half a day or a whole day, with preferential rates for members. The facilities include free Wi-Fi, unlimited use of audio-visual equipment including projector and laptop for Webex. We can offer refreshments ranging from pastries for breakfast to a hot lunch. Just let us know your requirements. The room is suitable for meetings of up to 20 people. It is available weekdays in office hours. Please check with our Office Services Coordinaor if you would like to use the room outside of the stated hire times. To find out the costs and/or reserve the room, email meetings@topra.org or call +44 (0) 7510 2560.
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N ov em ber 2012
Well done Anne!
InTouch Editors:
TOPRA Fellow and supporter Anne Wigmore completed a successful half-marathon organised by the Royal Parks Foundation last month. She ran for Breakthrough Breast Cancer on 7 October, but the Royal Parks Foundation supports a number of charities which are outlined on its website. ‘I completed the course in 2 hours 9 minutes which is pretty good going for me!’ she says. ‘We were blessed with a glorious sunny morning and the atmosphere was terrific knowing that so many charities were being supported.’ ‘Thank you so much to all you lovely people who sponsored me to raise some money for Breakthrough Breast Cancer,’ she added. You may still be able to add to Anne’s target by going to http://uk.virginmoneygiving.com/annewigmore.
Monique moves on After ten years working on the senior team of a leading software and service provider, Monique Garrett is striking out on her own. Retiring TOPRA Board member, Monique explains: ‘I spent almost 15 years working within the regulatory vendor community. This provided an excellent practical business foundation where I learned the importance of building relationships based on trust and the impact that trust has on internal and external communications. ‘I have created a company named PrismWorks, which will focus on providing strategic marketing and communications for growing companies. I wanted to incorporate the concept of a prism into the name because it suggests breaking light into spectral colours, reflecting light and viewing it from different perspectives. These are all key concepts that can be translated to the world of marketing and communications where we need to break down complex concepts, shift perspectives and look at things in new and different ways,’ she explains. Monique says that her work on the Board and as chair of the North America Leadership Team offered her the chance to work across geographic boundaries and introduced her to a network of some of the world’s leading regulatory resources in industry, academia and within global health authorities. ‘I have learned so much about working with global teams through my participation in TOPRA,’ she says. ‘My awareness of international issues across the regulatory landscape has been expanded significantly. I can honestly say that I look at these global challenges differently because of this unique experience. I hope to continue to participate in TOPRA in ways that help to expand recognition of TOPRA in North America.’
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently
Mrs Patricia Clark, Driffield, Humberside, UK* Mr Christopher Abegunde, Sunbury on Thames, Middlesex, UK* Miss Juliette Kirk, Pfizer, Sandwich, Kent, UK* Mr Simon Hiskett, Gravesend, Kent, UK* Dr Samantha Jones, Chippenham, Wiltshire, UK* Dr Daniel Drago, Bausch and Lomb, Switzerland* Dr Massimo Gallus, Eisai, Hatfield, Hertfordshire, UK* Dr Zoltan Forai, RegSana Pharmaceutical and Health Care Services, Budakeszi, Hungary*
Mrs Annmargret Tallberg, Merck Sharp & Dohme (Sweden), Sollentuna, Sweden* Dr MariaPaola Carosio, Laboratoires Boiron srl, Segrate, Italy* Ms Sarah O’Neill, Fannin, Dublin, Ireland Ms Nora Toland, Fannin, Dublin, Ireland Dr Peter Leuthi, Novartis Animal Health, Basel, Switzerland* Mr Oluwagbemileke Arikawe, Tipton, West Midlands, UK Dr Stephen Martin, Novartis Animal Health, Basel, Switzerland
Mr Christopher Chorley, Reading, UK Mrs Karina Dicker, Prostrakan, Galashields, Selkirkshire, UK* Mr Paul Williams, Stiefel (a GSK company), Uxbridge, Middlesex, UK* Mrs Sophie Marszele, Sanofi Pasteur, Marcy L’Etoile, France* Miss Rachel McGuckin, Tunbridge Wells, Kent, UK Dr Nicola Ann Razzell, Maidenhead, Berkshire, UK Mrs Melanie Schlegel, LFB Biotechnologies, Courtaboeuf, Cedex, France*
Miss Marlene Nogier, LFB Biotechnologies, Courtaboeuf, Cedex, France Miss Marilyn Eshikena, Sheffield, UK (Student) Ms Sofia Faraasen, Gothenburg, Sweden Mrs Devanshi Maharaja, Brampton, Ontario, Canada* Dr Theodor Langer, IMC University of Applied Sciences Krems, Krems, Austria* Ms Jeanette Davane, Clonsilla, Dublin, Ireland* Mis Royah Vaezi, Harpenden, Hertfordshire, UK Ms Camilla Lavoll, Oslo, Norway (Student)
Mrs Caroline Hyde, Switzerland (Student) Mr Adinath Kale, Mylan, Potters Bar, UK* Ms Mauricha Marcussen, Agano Solutions, New Albany, Ohio, USA* Mr Adam Brown, Swainby, UK (Student) Ms Terri Doerrzapf, Edenkoben, Germany Mr Sanjiv Bernardin, Teoxane, Geneva, Switzerland Dr Dorothee Krumwieh, Veyrier/ Geneva, Switzerland Dr Sabine Bernholt, Bayer, Berlin, Germany* Mrs Adeline Morel, Saffron Walden, Essex, UK *Registered Member
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. © 2012 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 €220. TOPRA members can read or download InTouch online at www.topra.org
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