February 2014
The TOPRA Newsletter – Keeping members in Touch
In this issue... Understanding our industry from other perspectives is a recurrent theme, and the MEB/CVZ meeting on Joint Scientific Advice emphasises the benefits of cooperation. A well-rounded regulatory professional will know what work is involved both pre- and post-licensing; this is something to aim for and makes our day-to-day work much more varied and interesting. The recognition of Dr Jefferys and Professor Rawlins (see page 2) shows that we have eminent regulatory scientists to act as our inspiration, as well as colleagues who encourage and inspire us in our very dynamic industry. Ishbel MacDonald Regulatory Consultant, MacDonald Regulatory Ltd Co-Editor, InTouch
Investing in knowledge Jonathan Trethowan, TOPRA President
Just as our winter climate is currently undergoing significant change, the constantly developing regulatory environment makes it increasingly important to maintain your professional skills. What a start to 2014 it has been in Cornwall! Along with much of the UK we have been soaked almost every day, faced gale force winds and suffered from some of the highest tides seen for decades. Then just ahead of a planned trip to New Jersey at the end of January, we saw news that winter storm ‘Janus’ had dumped a foot of snow in the area and temperatures were going to be extremely low for the duration of our visit. I’m pleased to report that none of this had too great an impact on the trip, and along with a member of our team I managed to fit in an evening in Manhattan to experience the excitement of the build-up to NFL Super Bowl XLVIII. We held the first meeting of the new TOPRA Board in January. It was great to welcome new members, and I’m confident we have a great team to drive our organisation in 2014. This will ensure that we are leading on the delivery of real value to our members and fulfilling our vision to enable and promote excellence in the healthcare regulatory profession.
Recently I have been thinking about how rapidly changing the regulatory landscape is, and how we as professionals are challenged to ensure we are prepared to meet these changes to our daily professional lives. In addition to our regulatory skill set we increasingly need to understand how our work as regulatory professionals fits in with other functions in our industry which are essential in bringing products to market. Within my own company I constantly encourage the team to invest time in developing knowledge of all aspects of our industry to enable them to appreciate how the important work we do fits into the bigger picture. I am aware that some companies are moving to create Global Market Access functions, bringing together disciplines such as Global Regulatory Affairs, Global Policy and Global Pricing. This is a direct response to the requirements of the regulatory authorities, policy makers and payers coming together.
With developments like these and no doubt more to come, I think it is vitally important that we as healthcare regulatory professionals think differently about training (see page 3). We can no longer only consider training directly related to our roles — it is important that we build on these skill sets by developing our knowledge and understanding of disciplines such as Pharmacovigilance, Health Technology Assessment (HTA) and Global Health Policy. With these additional skills and knowledge in place we can confidently progress our work knowing that we are delivering the best for ourselves, our organisations and ultimately the patients who we serve.
Awards 2014
Preparations are underway for this year’s Awards for Regulatory Excellence. If you would like to get involved in spreading the word as an Awards Ambassador, or helping to champion one of the categories, please contact rachel@topra.org for more information. We encourage everyone in the regulatory profession to nominate colleagues in recognition of outstanding work by individuals, teams and organisations. To register your interest in nominating and to be kept informed about the Awards, please visit https://www.topra.org/awards2014.
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
LEADING REGULATORY SCIENTISTS
acknowledged Former TOPRA President, Dr David Jefferys (left), and leading UK regulator Professor Sir Michael Rawlins (right) are listed among the 100 top UK scientists by the Science Council. Dr Jefferys’ and Sir Michael’s recognition in the Monitor/ Regulator category of the Science Council list reinforces how scientists are becoming increasingly important as scientific and technological advances become part of everyday life. Society needs the increasing reassurance that systems and technology are reliable and safe. ‘TOPRA put forward both Dr Jefferys and Sir Michael in the Science Council competition to raise the profile of scientists and all the varied roles they can fulfil,’ says Lynda Wight, TOPRA Executive Director. ‘We are pleased that our nominees have been endorsed by the independent
judging panel. It goes to show that regulatory science is an excellent example of how science is put to important use for the public good outside of the laboratory.’ Dr Jefferys has been recognised for his expertise advising UK and international governments and companies on the regulation of medicines, medical device issues and diagnostics; while Sir Michael was recognised for expertise and leadership in UK public health and clinical science policy issues. Responding to the announcement, David Jefferys said, ‘This is a great honour and recognition of the importance of regulatory
science and the contribution of the profession to public health both in the UK and globally.’ The judging panel included Joanne Hodges, Head of Science and Society Team at the Department for Business, Innovation and Skills (BIS); Dr David Evans, formerly BIS, Technology Strategy Board and a former trustee of the Science Council; Lady Carolyn Roberts, widow of the Science Council’s founding President, Sir Gareth Roberts; Ben Meghreblian, young scientist and representative from Sense about Science; Katherine Mathieson, Director of Education at the British Science Association; Nick Ross, journalist and
broadcaster; and Diana Garnham, Chief Executive of the Science Council. Sir Tom Blundell, President of the Science Council and Chair of the judging panel said that ‘the list shows that most scientists do not wear white coats and that scientists are not only found in universities and research labs: they are literally everywhere in a wide variety of careers and occupations.’ The Science Council List of the 100 leading UK practising scientists is available at http://www.sciencecouncil. org/content/100-leading-ukpractising-scientists.
its cooperation with CVZ on JSA. This will avoid unnecessary additional studies in the future and in turn will benefit the patient. From an industry viewpoint there is significant interest in joint advice. The advantages are clear, but it is important to have a structured process with clear agreements/definitions with regard to formality, confidentiality, responsibilities for sign-off, etc. During the very lively discussion a number of issues were discussed: T he predictability of JSA – to avoid additional problems •
A meeting of minds TOPRA and RegNed held a meeting on Joint Scientific Advice (JSA) on 28 January to discuss regulatory collaboration.
Speakers from the Dutch Medicines Evaluation Board (MEB), the College voor Zorgverzekeringen (CVZ) and industry discussed JSA in detail, considering how it could be implemented in the Netherlands. The MEB and CVZ have the same aim in optimising JSA: to anticipate earlier. By coming together, stakeholders are better placed to understand each other’s motivations. Whereas the MEB looks at the balance between benefit and risk, the CVZ looks at additional benefit, resulting in varied conclusions. The MEB would like to increase its expertise by expanding
TOPRA InTouch Newsletter – February 2014
companies will need to be able to determine any risks. The time it takes to execute JSA is also important, as there can be additional costs, especially for smaller companies
• Are the MEB and CVZ prepared to make concessions? The
speakers indicated clearly that both organisations are more than prepared to cooperate
• The relevance of MEB/CVZ as representatives of a relatively small country
• Concerns that the number of demands will increase due to European harmonisation. The MEB and CVZ requested around five pilots from the delegates, during which industry would place requests for JSA and arrange a meeting with clear agreements. It was suggested that a similar meeting could be organised in a year’s time to discuss the results of the pilots. This was a very successful and useful discussion looking to the future – in which the patient is ultimately the common denominator and for whom medicines should be made available without any unnecessary delays. Dr David Jefferys
TOPRA InTouch Newsletter – February 2014
Career pathway in easy steps As TOPRA enters its 10th year, we are launching a new tool to help members consider their own professional development.
Although individual career pathways vary, we have identified five key stages that can be applied to any regulatory career: exploring, establishing, consolidating, driving and influencing. The table below outlines how the TOPRA training and education programmes are mapped to these stages, making it easier to create personal development plans for yourself and for your staff. We will be rolling out more information over the coming year, including details of our Education Strategy Day planned for early summer. This will be an opportunity for any interested member to participate in a discussion about potential training topics, and to help shape the training programme for 2015 and beyond. In the meantime, to find a course that supports your professional development please visit https://www.topra.org/events.
Courses aimed at those who are exploring EU regulatory affairs and who are taking their first steps in the profession. Providing an overview of regulatory affairs (pharmaceutical, medical devices and veterinary medicines), they are also suitable for those working in associated areas, such as manufacturing and marketing, as well as support staff.
Courses aimed at those who are establishing a regulatory foundation and who typically have up to two years’ experience in regulatory affairs. These include our residential Introductory courses held in Spring and Autumn, and also our Fundamentals of the EU eCTD course.
Continuing Regulatory Education and Development (CRED) courses are a series of one- and twoday interactive workshops to enhance your knowledge in specific regulatory areas. They are suitable for those who are consolidating their regulatory competencies (2–5 years’ experience).
The CRED+ courses focus on topics in greater depth and at a more advanced level. They are aimed at those with more than five years’ experience who are driving their regulatory careers.
Masterclasses are 3-day workshops addressing specific regulatory subjects and are suitable for those who are at the stage of driving their regulatory career (5+ years’ experience). They are available as standalone courses or taken as modules to form the MSc in Pharmaceutical Regulatory Affairs.
Horizons conferences are open to all but are aimed at those who are at the stage of influencing the regulatory profession. They provide a forum for discussion and debate on current regulatory topics.
DRIVING ESTABLISHING EXPLORING •Those wanting to take their first step in regulatory •Those in other disciplines who need an overview
•Those who have recently joined the profession •Those whose regulatory experience is outside the EU
CONSOLIDATING •Experienced professionals committed to developing their regulatory and management competencies 2—5 years’ experience
•Those at a senior level taking on additional responsibilities or looking to diversify their skills
The annual TOPRA Symposium is a vibrant forum, where representatives of industry and regulatory agencies come together to discuss today’s regulatory issues and debate future plans for regulation. The three symposia – pharmaceuticals, medical devices and veterinary medicines – are open to all regulatory professionals.
INFLUENCING •Discussion, debate, and networking opportunities for senior professionals 8+ years’ experience
5+ years’ experience
6 months—2 years’ experience
Up to 6 months’ experience
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
TOPRA InTouch Newsletter – February 2014
MEMBERSHIP NEWS
Community spirit In this month’s column, Head of Membership Duncan Judd explores the wide variety of regulatory roles in which TOPRA members are involved. TOPRA Executive Director, Lynda Wight, was recently asked to present a prize to Suzan Job-Blake at the University of Hertfordshire’s School of Pharmacy. Suzan was awarded with Best Overall Student and Best Student in Law, Ethics and Professionalism. Congratulations!
Understanding our members, through the information and feedback you provide us with, ensures we can continue to develop our educational offerings, deliver your learning outcomes and create relevant networking opportunities. We have active members from all sectors: from consultancy to academia; clinical research organisations to big pharma; health technologies to veterinary; regulatory agencies to notified bodies. Your feedback enables us to provide you with tangible benefits and an independent space in which to network, talk freely and share expertise with colleagues. Coming together as a profession in an organisation like TOPRA not only benefits individuals, but the expert knowledge of our members
can help shape the future of healthcare regulation and improve patient care. As one member said recently: ‘Being part of these discussions, and having this “extra” knowledge, benefits my company too as I take back the information and share with colleagues so it is a win-win all round.’ Why not join in our extensive networking activities? From Special Interest Networks – SPINs – to TOPRA In groups, the wealth of experience of our members helps engender vibrant, interesting and informative discussions – and along the way more enduring friendships are often formed too. To find out more about getting involved, please email me at duncan@topra.org.
NEWTOPRAMEMBERS
TOPRA welcomes the following new members who joined recently Ms Allison Kennedy, Manager, Cangene Corporation, Regulatory Affairs, Winnipeg, Canada* Ms Myriam Antoun, Director Regulatory Affairs, Baie Durfe, Canada Mr Martin Schimmer, Attorney at Law, Czech Republic Dr Serge Kosobokovs, Regulatory Affairs Manager, Premier Research, Riga, Latvia Mrs Andrea Ochoa, Director, Premier Research, Spain* Mrs Ann-Cathrin Jareman, Managing Director, Scandinavian Regulatory Services AB, Saltsjo-Boo, Sweden* Mr Johan Stromquist, CEO, NDA Group, Upplands Väsby, Sweden* Dr Nathalie Gass, Regulatory Program Manager, F Hoffmann La Roche, Basel, Switzerland Mrs Margarita Rodriguez Espinoza, Documentation Specialist, Novartis Animal Health Inc, Basel, Switzerland Dr Janneke Westra-de Vlieger, Senior Regulatory Affairs Manager, Astellas, Leiden, The Netherlands Dr Edwin Van Amersfoort, Director, Pharming Group NV, Leiden, The Netherlands
Dr Hema Borde, Associate Director, Biogen Idec Ltd, Maidenhead, UK* Mr Mark Trust, Associate Director, Gilead Sciences International, Cambridge, UK* Miss Anuja Parekh, Senior Regulatory Affairs Associate, Gilead Sciences International Ltd, Uxbridge, UK Dr Janine Jamieson, Pharmaceutical Assessor, MHRA, London, UK* Prof Theo Raynor, Professor of Pharmacy Pratice, University of Leeds, Leeds, UK Ms Komal Patel, Regulatory Affairs Officer, Medreich Plc, Feltham, UK Mrs Susan Russell, Welwyn Garden City, UK Dr Sophie Tuley, Regulatory Affairs Officer, Rosemont Pharmaceuticals Ltd, Leeds, UK* Mrs Fiona Seward, Regulatory Affairs & Quality Associate, Leo Pharma Ltd, Maidenhead, UK Ms Chinelo Oganya, Regulatory Affairs Associate I, Gilead Sciences International Ltd, Cambridge, UK Mr Guillaume Barriere, Senior Regulatory Affairs Associate, Gilead Sciences International Ltd, Uxbridge, UK
Ms Ramandeep Walia, Alcon Eye Care UK Ltd, Regulatory Affairs Assistant UK & Ireland, Camberley, UK Mr Ben Continsouzas, NDA Regulatory Science Ltd, Leatherhead, UK Mr Dhruv Patel, Regulatory Affairs Executive, Leo Pharma, Maidenhead, UK* Ms Marina Anton-Matias, Regulatory Affairs Officer, TEVA UK Ltd, Harlow, UK Mr Scott Price, Senior Regulatory Executive, Zoetis UK Ltd, Tadworth, UK* Miss Catherine Clarke, Regulatory Affairs Associate, SEQ Ltd, Isle Of Man, UK Mr Stefan Peev, Regulatory Affairs Associate, SEQ Ltd, Isle Of Man, UK* Mr Sujit Korade, Regulatory Affairs Associate II, Gilead Sciences Ltd, Cambridge, UK* Mr Siddhesh Desai, Chatham, UK (Student) Mr Antony Okanta, London, UK (Student) Dr Michael Tremblay, Director, Cassis Ltd, Ashford, UK* Mr Satish Muchakayala, Reading, UK* Miss Martha Manini, Junior Regulatory Affairs Associate, SEQ Ltd, Isle Of Man, UK
Dr Alexandra Zourlidou, Senior Associate Regulatory Affairs, Amgen, Uxbridge, UK Dr Kevin Godinho, Regulatory & Development Manager, Bayer HealthCare, Newbury, UK* Mr Patrick Joshua Kerr, Regulatory Affairs Specialist, GW Pharma Ltd, Salisbury, UK Mr Venkat Reddy, Corporate Regulatory Affairs Manager, Sunkara, Aesica Pharmaceuticals Ltd, Cramlington, UK* Mrs Sarah Eves, Responsible Person, Ministry Of Defence, Bristol, UK* Dr Victoria Olaiya, Regulatory Affairs Manager, Cancer Research UK, London, UK Mr Brian Lalor, Regulatory Affairs Officer, Crawley, UK* Miss Daniela Contreras, Richmond, UK Mr Shepard Bentley, President & Principal Consultant, Bentley Biomedical Consulting LLC, Laguna Niguel, USA*
InTouch Editors: Jenine Willis, Greer Deal and Ishbel MacDonald
Assistant Editor: Rachel Cook
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 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. © 2014 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 nos. 000055553-0001 and 0002.
*Registered Member
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION