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T he T O P R A N ews l etter – K eepin g m e m b ers in T o u c h
In this issue We have much to look forward to in these coming months, and many opportunities to participate in TOPRA activities, as you will see in this month’s edition. As Patrizia says in her message, we can make a difference to our profession by contributing to relevant consultations. Our opinions are important so if you have a chance to have your say, make sure you do! Initial preparations and the programme for this year’s Symposium are shaping up well (see page 2). The TOPRA Regulatory Affairs Awards are also being planned for later in the year (see back page). Why don’t you start thinking about who you will nominate? But there are also many opportunities to participate all year round, for example on the Regulatory Rapporteur Editorial Team. And to InTouch too! There are plenty of ways to contribute according to your spare time and preferences (see the back page). Please get involved in your professional association. Virginia Guellal, Co-editor
Make your voice heard! A message from Patrizia Nestby, TOPRA President
One of TOPRA’s strategic objectives is to continue to flourish and excel as a respected partner in facilitating debate on regulatory topics in a neutral environment for the benefit of the whole profession. Although TOPRA has already been providing such a platform for debate for many years, for example at the Annual Symposium, there is a keen interest to expand this role further. In addition to facilitating debate, TOPRA is also increasingly approached as a stakeholder and invited to actively participate in the debate by providing input into consultations on regulatory matters. Obviously the strength of our professional organisation is that we can combine forces; the voice of a professional organisation with more than 3,000 members from various regulatory backgrounds is more convincing than the voice of individuals. We now have to turn to the obvious question: is there, or can there be, one TOPRA voice? As an organisation that prides itself on its independence, the challenge for TOPRA is that its membership includes regulatory professionals from industry and agencies, from different areas within healthcare regulatory affairs and with a wide geographical spread. How can we express the voices of professionals with so many different backgrounds? Also, how do we define ‘matters affecting the profession’; do these
include providing input on legislative proposals or even technical aspects in regulatory guidelines? Engagement In my view, TOPRA will have to raise a voice in regulatory areas so it can execute its role to promote the important role of regulatory affairs, provide informed and considered feedback and to provide the necessary support to the profession. On the other hand, we have to avoid alienating members who do not share the consensus view; which makes it all the more critical for all members to participate in these discussions so that this view debates the totality of the impact of the issue at hand on the profession as a whole. I believe that TOPRA should engage in the debate and provide input on matters that do affect the profession, although this should be done with great consideration and
always keeping in mind that it is an almost impossible task to obtain and to share the views of all membership groups, especially without active representation and input into these debates. However, this challenge can also be turned into a positive. TOPRA is in a unique position of representing this broad membership. The opportunity is to create a powerful voice which spans across the entirety of a particular proposal and its impact to industry and regulators alike. The challenge ahead is to create this voice which is not splintered by different views but provides insightful reflection on the impact of issues to the whole profession – something no other stakeholder is currently in a position to offer. It would be great if you – as a member of TOPRA – would engage in these discussions and let us know what your opinion is.
It’s time to renew your membership, if you haven’t done so
We are in midst of the busy annual membership renewal process. Thank you to everyone who has already submitted their 2013 subscription. Everyone will receive a receipt for their subscription, but please allow a few weeks for us to process your renewal. If you haven’t received a renewal notification yet, please contact membership@topra.org.
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Symposium 2013 preparations
Programme takes shape
On 14 January the Symposium Working Party had its first full meeting with the Portuguese Regulatory Agency, Infarmed, in Lisbon, to discuss the programme and arrangements for this year’s Annual Symposium. The 2013 Symposium will be held in Lisbon, from 16–18 October at the Sheraton Hotel.
The draft programme so far includes sessions on:
Parallel Symposia and SME day
● The clinical trial Regulation proposals
As always there will be parallel symposia on Medical Devices and Veterinary Medicines and the ever-popular SME Day will also return. The event will include plenty of networking opportunities including two receptions, plus a dinner which is planned to take place in the Panorama Restaurant on the 27th floor of the Sheraton Hotel (see photo above). Should you wish to register your interest in receiving Symposium updates, go to www.topra.org/sym2013rf. For more information and to keep up-to-date with the progress on the TOPRA Symposium 2013 go to www.topra.org/symposium2013. A full Symposium website will be launched in April.
● The new EU Medical Device Legislation, borderline products
and the US FDA perspective on combination products ● The role and activities of Infarmed ● Combination products – clinical development, pricing and joint advice ● Falsified medicines ● Social media and pharmaceutical industry ● Health Technology Assessment (HTA) and pricing – a new regulatory initiative? ● The Centralised Procedure and the role of the Pharmacovigilance Risk Assessment Committee (PRAC) and the CHMP ● New generics.
Pictured enjoying some southern European sunshine by the open air pool at the Sheraton hotel are [left to right]: Brenton James – UK ; Christopher Bailey – TOPRA; Joao Da Silva Duarte – France; Ana Gaspar – Portugal; Neil Fisher – TOPRA; Antonieta Lucas – Portugal; Alan Hunter – UK; Erik Smit – TOPRA; Paolo Biffignandi – Italy; Margareth Jorvid – Sweden (Co Chair); and Craig McCarthy – France, (Chair).
TOPRA ADDS ITS VOICE TO RECENT CONSULTATIONS One of the benefits of being a member of a professional association like TOPRA is knowing that your profession has a ‘voice’ when it matters. This month we report on two recent consultations that TOPRA members have contributed to. From time to time, regulations and processes develop that affect the way we work, the training we need or the status of our profession, whether we work in a company, an agency or as a consultant. In these instances TOPRA can have an advocacy role and put the profession’s viewpoint forward. There have been two recent examples of this. First, the proposal from the Commission on a new Regulation for Medical Devices included recommendations for the qualification and experience levels for responsible regulatory professionals. It is obvious that this is a topic on which a professional association should have a view, and so it was discussed by the Medical Technologies SPIN and members of our Professionalism Committee. The Board took their views into consideration and a response to these proposals has been submitted to the Commission and some member states. We have also made the relevant MEP aware of our views. Second, the MHRA published a consultation on its corporate plan. TOPRA drew this to the attention of all members in a recent
e-newsletter and invited any member to make comments that could be incorporated into our response. We also invited members of our consultation group (who are senior experienced TOPRA members) to give their input. As you may imagine, the comments received related to aspects such as the interaction of the MHRA with stakeholders, training of staff and communication of the value of the regulatory process to the wider community. These aspects were included in the TOPRA response. Copies of the responses will be made available on the TOPRA website in due course. Members who become aware of issues on which they think TOPRA should have a view on behalf of the whole profession should contact the office. Any member who would like to be part of the consultation group can put their name forward. The Board is currently evaluating ways in which wider input into these consultations can be encouraged and again, if you have any opinion on this do let us know. Email Board members via the website or contact topra@topra.org.
Visit TOPRA at the DIA EuroMeeting in Amsterdam, 4-6 March 2013, stand 805
T he TOPR A N ewsletter – K eeping mem b ers in To uc h
In the previous issue we reported that a Roundtable discussion had taken place on 10 January at the Royal Society. This month we are pleased to give a fuller report on discussions between regulatory professionals and the guest Marina Yannakoudakis, MEP (pictured). Marina is an MEP for the London region in the UK and sits on the Environment, Public Health and Food Safety Committee (ENVI) within the European Parliament. The role of ENVI is to scrutinise legislation proposed by the EU Commission. Three forthcoming pieces of legislation are of particular interest to regulatory professionals: clinical trials, medical devices and in-vitro diagnostic (IVD) medical devices. The aim of the clinical trials legislation is speedier approvals and hence cost savings for academia and industry while maintaining patient safety. The discussion covered risk, data retention, interventions, reporting procedures, insurance and transparency of clinical data. Marina felt that the chances of this legislation getting through before the end of this parliamentary term were slim. The current devices legislation is very old; new regulations need to take account of changes in technology and recent issues concerning the control of devices in the market. The discussion touched on unique label identifiers, implant passports, a central manufacture database, clinical data database, notified bodies and conformity assessment. Marina felt that there was a good chance this legislation would be on the statute books by the end of this parliament. The in-vitro medical devices legislation was discussed briefly. It has a wider scope than the old legislation, covering new technology. As with the devices legislation, there will also be more classes of IVD devices.
Welcome
Rachel Members who have visited the TOPRA offices recently will have met Rachel Cook who is our new Office Services Coordinator. Rachel graduated from the University of Leicester in 2012 with a degree in English, joining TOPRA as Office Services Coordinator in her first role post-studies. In this position, she acts as a valuable support to all office activities and a welcome face to all visitors. Rachel is responsible for booking meeting rooms and telecoms, so if you wish to arrange a meeting for your TOPRA group – or for your business meetings – contact rachel@topra.org for more information.
FEBRUARY 2013
News From the Board... TOPRA Board members met for two days in January. The first day was an update session arranged with a specialist in corporate governance for membership associations and was an opportunity for Board members to be reminded of their legal duties as Directors and to reflect on the specifics of the TOPRA constitution. ● As part of the regular Board meeting the next day, some of
these themes were picked up with the help of Alan Hunter who attended as the Board’s constitutional advisor. Ways to give members more access to the Board and for developing the reporting of Board activities were discussed. ● There was some discussion relating to the Board vacancy and
the wish of the Board to deepen its skills base in certain areas by appointing additional members. This will be decided in advance of the March meeting. ● The financial report for November was reviewed and the
year-to-date figures indicated that TOPRA should see figures for 2012 slightly better than budget, which is pleasing in these difficult economic times. ● The Board reflected on the success of the 2012 Awards and
looked forward to the 2013 event with some ideas for future developments: any members who have thoughts on this are welcome to contact TOPRA via the Awards website. ● The Board reconfirmed its desire for TOPRA to submit
responses to consultations when there is a professional aspect and asked two Board members to devise recommendations for the best process. In the meantime we agreed to submit responses to the proposed Regulation on Devices and to the MHRA corporate plan. Copies of these submissions will be made available for TOPRA members to read in a closed members-only area of the website. ● The terms of cooperation between TOPRA and RAPS
and between TOPRA and International Society of Pharmacovigilance (ISoP) were discussed and agreed. Any member who would like to learn more about the Board is invited to contact Board members directly via the website or to email lynda@topra.org.
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FEBRUARY 2013
Awards
InTouch Editors:
Regulatory Rapporteur
Jenine Willis, Greer Deal and Virginia Guellal
Editorial Team Update
2013 This year’s TOPRA Regulatory Affairs Awards are taking shape. If you would like to participate in developing the Awards this year, please contact jenine@topra.org for information on ways that you can get involved. Find out more about last year’s Awards and this year’s updates by going to www.regulatoryaffairsawards.org or contacting awards@topra.org. We’re please to announce that Samarind will be supporting this year’s Innovation Award category. If you would like to support the Awards through sponsorship, please contact jenine@topra.org.
samarind RMS
OPPORTUNITIES TO PARTICIPATE
The Editorial Team has been reviewing how it works and has developed a constitution with a more defined structure. Editor-in Chief Leslie Dowling is pleased to announce that the following posts have been filled: ● Deputy Editor - Carol Huntington ● Associate Editor - Interviews: Anita Sibal ● Associate Editor - Meeting reports: Julie Warner ● Associate Editor - SPIN liaison: Paul Kuiken In addition, we have a team of more than 20 consultant editors who collectively devote their time to planning content, and sourcing relevant, informative and timely articles for the journal. Consultant editors also act as issue editors for editions of their choice. Being part of this active editorial team is an interesting and rewarding activity – and there are always opportunities for TOPRA members to get involved with the journal. For example, have you considered submitting an article to the journal? We’re happy to consider articles on any regulatory topics, ranging from HTA to paediatrics. Could you write for us, or recommend a colleague? If you would like to find out more about contributing or becoming a consultant editor, please contact madeleine@topra.org. Madeleine Meyer is the journal’s Managing Editor who provides support and editorial input for the team.
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently Ms Lyn Morgan Sanofi Pasteur, Marcy L’Etoile, France* Mrs Elvi Metsaranta, Finland Miss Natasha McGinty, GSK Consumer Healthcare, Weybridge, Surrey, UK Mrs Laurence Brugere, Abbott Products Operations, Allschwill, Switzerland* Dr Caroline Dick, Vectura, Chippenham, Wiltshire, UK* Ms Bonita Tapp, GlaxoSmithKline, Bourne End, Buckinghamshire, UK Dr Imran Shah, Abbott Laboratories, North Chicago, US* Ms Sybil SkinnerRobertson, AbbVie, Evanston, Illinois, US*
Dr Ute Krahl, BioReg Consultancy, Dusseldorf, Germany* Ms Marie Domitille Petit, Thomson Reuters, Paris, France* Mr Rishi Dewan, Tyne and Wear, UK (Student) Mr Simon Williams, Teva Pharmaceuticals Europe, Essex, UK Mr Khayyam Darr, Stockport, Cheshire, UK Mr Alex Bennetts, Perrigo, Braunton, Devon, UK Mr Rob Worsley, Perrigo, Braunton, Devon, UK Dr Hanne Aae Theilgaard, Novo Nordisk, Soborg, Denmark* Miss Jennifer Hobson, Guildford, Surrey, UK*
Ms Silke Maier, F Hoffman-La Roche, Basel, Switzerland* Miss Amanda Vella, Smith & Nephew, Hull, UK Mr Vamshee Juvadi, Amdipharm, Basildon, Essex, UK* Mr Rajesh Pawar, Gilead Sciences, Cambridge, UK Ms Adeline Boucher, UCB Pharma, Brussels – Anderlecht, Belgium Dr Mary Bogdanovski, CSL Ltd, Victoria, Australia* Miss Sushma Mahenderkat, London, UK (Student) Mrs Emily Huddle, GlaxoSmithKline, US Ms Kathleen Conlon, Killiney, Co Dublin, Ireland (Student)
Ms Maryann Ezidinma, Tallaght, Dublin (Student) Mr David Timms, Dudley, West Midlands, UK Ms Anna Eslau, PEC Services, Glostrup, Denmark Mr Dipesh Lakhan, AbbVie, Maidenhead, Berkshire, UK* Mr Narshly Mazaran, Harlow, Essex, UK (Student) Mr Matthew Lait, Wockhardt UK Ltd, Wrexham, Clwyd, UK Mr Vikash Patel, Mercury Pharma, Croydon, UK* Mr Martin Mitchell, Dumfries, UK (Student) Dr Karen Kelso, Novella Clinical, Stevenage, Hertfordshire, UK*
Dr Jennifer Sims, France* Dr James May, Gilead Sciences, Cambridge, UK Mr Pratyush Bhartiya, London, UK* Dr Hans Niefenthaler, F Hoffman-La Roche, Basel, Switzerland Ms Cindy Martin, Bausch & Lomb, Irvine, CA, US* Mr Sreenivasarao Degala, Manchester, UK (Student) Mr Faizan Jameel, Charlestown, New South Wales, Australia (Student) Mr Brian Cook, Uxbridge, Middlesex, UK Dr Nigel Hernandez, Philadelphia, PA, US* *Registered Member
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
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 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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