K E E P I N G Y O U

In this issueDo read David’s stimulating editorial opposite. Our profession has gone above and beyond the term ‘regulatory a� airs’ to become a science and play a major role in the healthcare industry.

Don’t forget the TOPRA Awards are now accepting entries. Did you know you can start the nomination process online and save your entry for later if you don’t have time to do it in one go? Go on, we must make sure those colleagues/friends get rewarded for work well done.

We include several news stories on members. Some sad, like the loss of Owen Farrugia who gave so much to our profession (see back page). Others good, like new roles or learning about healthcare in other countries.

Virginia Guellal,Co-editor, InTouch

Some use the terms interchangeably while for others there can be intense debate as to whether regulatory science describes the work we undertake or whether we should stick to the older term of regulatory affairs.

At one level the debate is of little consequence, but at another it highlights a significant emerging trend. The major regulatory agencies are increasingly referring to regulatory science and they are setting it out as part of their core mission. Indeed it was a major theme expounded by Margaret Hamburg when she took over the post of FDA Commissioner and has been extensively deliberated in recent publications from the EMA and the PMDA in Japan.

As so often happens, the pharmaceutical and medical device sectors have assumed that regulatory ‘science’ applies only to our industry, whereas in fact it is a concept embracing a wide range of regulated sectors, many of which would claim to be more involved in the topic and for considerably longer than the pharmaceutical sector. This is reminiscent of how pharma rather arrogantly claimed to have discovered ‘benefit-risk’.

The term regulatory science signifies the increasingly important

and wider strategic role that regulatory affairs professionals are undertaking.It is a critical activity incorporating regulatory intelligence and the strategic planning needed to ensure that a comprehensive and achievable global strategy is put in place.

Global strategyThis also needs to encompass market access and the requirements of payers for health technology assessment (HTA). It places the regulatory affairs professional in a key position within the company, because frequently the global regulatory lead is the one and only person who covers all aspects of the product’s development. This is not only a broad requirement but also endures throughout the entire lifecycle of the development programme. Regulatory is no longer simply a support function, rather it is a key strategic driver for product development.

What’s in a name?A message from David Je� erys, TOPRA President

This month I am returning to an old topic but from a slightly di� erent angle: the debate about ‘regulatory science’ and ‘regulatory a� airs’.

This interface with market access is a crucial one. In most markets, regulatory approval is not the endpoint. Rather it is the start of the next phase of securing market access through HTA, reimbursement and pricing negotiations.

The key role played by regulatory affairs professionals in this new world of product development needs to be clearly stated and promoted. The interaction with those working in HTA and market access is vital and such understanding and cross-fertilisation was one of the themes discussed at the recent TOPRA/RAPS collaborative meeting. It was also a major topic discussed at the last TOPRA Board meeting.

We need to work with this new sector and to understand and embrace some its skills. Above all, we need to see ’regulatory science’ as signifying the emergence of new opportunities, and not as a threat.

MHRA NEWSAs you may already know, the MHRA has now entered the Medicines ‘Red Tape Challenge’.

This is a unique opportunity for all stakeholders to comment on the way the MHRA regulates. All medicines regulations are now online at http://www.redtapechallenge.cabineto� ce.gov.uk/themehome/medicine/ where you are able to comment on them.

T H E T O P R A N E W S L E T T E R – K E E P I N G M E M B E R S I N T O U C H APRIL 2012

This month I am returning to an old topic but from a slightly di� erent angle:

TOPRA PEOPLE

K E E P I N G Y O U

TOPRA Awards Update 2012Calling all Ambassadors for Regulatory A� airsNominations for the TOPRA Regulatory A� airs Awards are now open. Help us to celebrate all that is best about the regulatory profession and the people in it by spreading the word about these prestigious Awards and entering your colleagues.

samarindRMSSupporting the Awards this yearFor further information about the 2012 TOPRA Awards, please contact Mark Wilkins, by email mark.wilkins@ashridgecommunications.com or telephone: +44 (0)1753 714999

AWARDS TIMELINESRegister your interest in entering the Awards – NOW!

Closing date – Friday 22 JuneShortlist announced – mid-SeptemberAwards ceremony – 28 November The TOPRA Regulatory A� airs Awards 2012 will be held at the Radisson Blu in Portman Square, London, UK.

Why should you nominate someone for these Awards?• It is a wonderful way for a senior manager

to publicly express pride and gratitude to an individual or team for a job well done

• It brings international recognition of the work of the nominee(s) and their employing organisation

• It impresses clients and colleagues to see the nominee recognised in this way

• It demonstrates the commitment of the nominee and their employing organisation to excellence in regulatory affairs

• It encourages others to strive toward Award-winning performance in future years!

In 2011 we had winners from across the world who work as independents or in major pharma, CROs, agencies and academic institutions. These are truly international Awards open to all regulatory professionals – not just TOPRA members – judged by a prestigious panel of internationally renowned experts.

Maybe you know someone who should receive such recognition. If so why not register your interest in nominating your colleagues now? The new Awards website (www.regulatoryaffairsawards.org) has full details on

all the categories and links to the nomination forms. There is detailed guidance on how to complete the forms and information on how the entries will be assessed.

Nominations close on 22 June 2012. If you have any questions or need more support, you can contact awards@topra.org.

Could you be an Ambassador for the TOPRA awards?We are looking for Ambassadors to spread the word and encourage even more nominations this year. Our Ambassadors will reach out to colleagues or clients in their professional networks to:

• Make them aware of the Awards - the categories and timelines

• Encourage colleagues to make nominations

• Think of worthy nominees that they could put forward themselves

• Help build up the excitement to the glittering ceremony we will hold on 28 November at the Radisson Blu in Portman Square, London, UK.

YOUR OPINION COUNTS!We hope TOPRA members have recently received details of two surveys we are collaborating in. The first is the RAPS Scope of Practice survey. RAPS has conducted this research for more than 20 years and it is carried out every two years. This research helps understand the changing roles and responsibilities of regulatory professionals in the healthcare sector, and also gives information on the levels of salary and benefits for professionals at all levels of experience. TOPRA’s support for this will allow the two organisations to work together to jointly evaluate the needs of the profession, so that both can support the development of regulatory affairs as a whole. Please go to www.raps.org/2012globalstudy to participate.

TOPRA is also supporting a research programme into e-learning being run by the Professional Associations Research Network. PARN has worked with a number of organisations across a spectrum of professional disciplines to develop a questionnaire to determine the use of and attitudes to this mode of learning. The results will be made available for TOPRA specifically and for all respondents so this will give us some very helpful information to inform how we move forward into e-learning in the future. Please take some time to complete this survey, at http://www.parn-test.com/Surveys/ELearningMMS/elearningmms.htm, which will be open until 30 April 2012.

If you’d like to help in this way, please contact jenine@topra.org for more information and support material.

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

TOPRA Sta� WHO’SWHO WHO’SWHO WHO’SWHO WHO’SWHOA series in which InTouch pro� les members of TOPRA’s o� ce team

Steve Wratten - Director of Corporate Services

TOPRA PEOPLE DUBLINAfter the great success we had last year in Rome, we are now moving North and a little further to the West within Europe to visit Dublin. As in previous years we are working with the local regulatory agency, which in Ireland is the Irish Medicines Board (IMB).On 7 March TOPRA In Ireland organised a networking event where the 2012 Symposium was officially launched. Following an introduction by the Symposium Working Party chair, Craig McCarthy, more than 70 delegates heard the latest issues in pharma, medical devices and veterinary regulatory affairs in Ireland from IMB speakers Ann O’Connor and J Gabriel Beechinor.

The chair of the TOPRA In Ireland group, Ronan Donelan, then spoke about the group in general and its involvement in organising upcoming TOPRA events, particularly the Symposium.

On the agenda of the 2012 Symposium we have the perennial key topics of clinical trials, scientific advice, regulatory procedures and pharmacovigilance. Added to that our expert speakers will also be addressing some new topics such as falsified medicines and devices, information to patients, access to medicines and switching of prescription status.

In addition to the three main Symposia we welcome back the SME day – the first was run in Sweden – which will be held on Monday 1 October, specifically addressing the concerns of smaller companies. The main Symposium will be held from midday on Monday 1 October to lunchtime on Wednesday 3 October. The increasingly popular Veterinary Symposium will be extended to a longer meeting from midday on 2 October to mid-afternoon on the 3 October. We are planning the Devices Symposium for Tuesday 2 October.

Please note 1-3 October 2012 in your diaries and come to Dublin – perhaps make a weekend of it!

TOPRA Symposium plans LAUNCHED IN DUBLIN

EDITORIAL BOARD NEWSPaolo Biffignandi has stepped down from his role on the Editorial Board of Regulatory Rapporteur. Paolo’s outstanding contribution to the content of the journal and

his continuing support over a long period of time (part of which as Chair) have been greatly appreciated. However, Paolo will move on to be part of a new strategic committee that will guide the activities of our publications division where his experience will be of great value.

NEW ROLE FOR KAREN BROWNFormer InTouch editor, Karen Brown moved to CooperVision late last year. She is now Regulatory A� airs Manager EMEAA with responsibility for the regulatory activities in these regions.

Karen has a degree in Biological Sciences majoring in microbiology and has worked in medical device regulatory a� airs for 12 years. She began her regulatory career as Product Registration Manager for Pall Filtration and moved to Ciba Vision in 2003 as Regulatory A� airs Manager UK and Ireland.

Karen is an active member of the MedTech SPIN group and a member of the Regulatory Rapporteur Editorial Board.

Steve joined TOPRA in October 2007, to take on the wide-ranging remit of managing all our back-office functions including finance, HR, IT, legal, contracts, premises and company secretarial.

A qualified Chartered Management Accountant, Steve has worked for many companies that are household names, including Fedex, Ready Mix Concrete, Prudential, and British Rail. As he says, ‘ I have decades of accounting experience in small (Hall Roofing) to large companies (Cable & Wireless) across sectors from engineering to retail.’

Steve also has experience of the pharmaceutical industry

from his work with a medical charity. ‘I have been a member of the Haemophilia Society, both as a patient representative and trustee, since 2002,’ he explains.

What does he like most about working for TOPRA? ‘The varied nature of emerging needs and reacting to difficult often unforeseen questions,’ he replies.

Members can contact him regarding financial queries and for advice, if they are thinking of standing for the Board.

Steve enjoys going to the theatre with his wife and – when the opportunity arises – attending ‘big events’ such as Royal Ascot, Henley Regatta and so on.

Do you have any news?If you have any news - whether it’s a new job, new baby, marriage, or participation in skydiving, abseiling or marathon - that you would like to share with members, please email jenine@topra.org

APRIL 2012

w w w. t o p r a . o r g / i n t o u c h

TOPRA – Provides: Education, Information, Training, Networking, Support.DUBLIN

TOPRA – Provides: Education, Information, Training, Networking, Support.DUBLINDUBLINDUBLINDUBLINDUBLINSymposium2012DUBLINDUBLINDUBLINDUBLINDUBLINSymposiumDUBLINDUBLINSymposiumDUBLINDUBLIN2012DUBLINThe 9th TOPRA Annual

K E E P I N G Y O U

Miss Alix Alderman, Abbot Laboratories, US*Mrs Lisa Allenby, St Neots, UK*Mr Abu Baker, Advanced Clinical Recruitment, She� eld, UKMr Christopher Bates, London, UK (Student)Mrs Trupti Bhatt, Amdipharm, Basildon, UKMrs Gabriele Bieska, F Ho� man La-Roche, Basel, SwitzerlandDr Gabriel Bohl, Strasbourg, France*Dr Derradji Boumrah, Margate, UKDr Katherine Bowen, Eli-Lilly, Windlesham, UKMrs Catherine Brannan, Reading, UKDr Christine Daniela Cahyadi, SingaporeMrs Anna Cavalleri, Novartis Animal Health, Basel, SwitzerlandMs Kulvi Chana, Maidenhead, UK*Mr Alan Collins, Gilead Sciences International, Cambridge, UKDr Alexandra Cook, DSTL, Salisbury, UK

Ms Lorena Courlaender, Teva UK, Harlow, UKMs Rachel Creane, Portmarnock, Ireland*Mr Chris Dawson, Cooper Vision Manufacturing, UKMiss Karine Eudes, Cytheris, France*Mr Kamran Fathi, Glasgow, UK*Mrs Patricia Finnegan, Teva Pharmaceuticals, Dundalk, Ireland*Mr Paul Fletcher-Dyer, Quintiles, Reading, UK*Ms Laura Campo, Qualitec Farma, SpainMr Chris Freer, Biogen Idec, Maidenhead, UK*Mr Marcus Garbe, Vitalograph, Buckingham, UK*Ms Stephanie Garret, Gilead Sciences International, Great Abington, UKDr Gassmann, Riehen, Switzerland*Mr Barry Geoghegan, Kompass Regulatory Services, Roscommon, Ireland*

Dr Louise Gill, GlaxoSmithKline, Uxbridge, UK*Dr Frederick Golec, MCRegA� , USMiss Valerie Gra� eo, P� zer Consumer Healthcare, Maidenhead, UKMrs Farazana Habib-Ullah, London, UKMr Nasser Hassan, RegSource-Consulting, Cary, UK*Mr Donal Hempenstall, Uxbridge, UKMs Lucy Herlihy, Kells, IrelandMr Terry Houiellebecq, Mylan, Potters Bar, UK*Miss Alexandra Hyde, Manchester, UKMr Timothy Irwin, Letchworth Garden City, UK*Ms Kim Johnson, Celgene Europe, Uxbridge, UKMs Janet Jones, United Biosource Corp, London, UKMr Junji Kachi, Teikoku Pharma UK, London, UKMr Michael Kemmann, ADAPT Localisation Services, Bonn, Germany

Mr Richard Knightly, Ireland (Student)Mr Gaurav Kulkarni, Teva UK, Harlow, UK*Dr Brynn Kvinlaug, SwitzerlandMiss Julie Little, Cambridge, UKMs Priya Ludhera, Hospira UK, Leamington Spa, UKDr Surya Maddipatla, Teva UK, Harlow, UK*Miss Emma Martin, Athlone Laboratories, Roscommon, IrelandDr Clotilde Mazerolles, Mazerolles Consultants, Sene, France*Mrs Mindy McCann, New Jersey, US*Dr John McKnight, GlaxoSmithKline R&D, UK*Mr James McVeigh, Blackpool, UK*Mrs Surabhi Melmane, London, UK*Mrs Susan Metz, Liquent, US*Mr Hardik Mistry, Woodley BioReg, Hudders� eld, UK

Passage to IndiaTOPRA member Graham Donaldson recently spent six weeks travelling through Rajasthan and Gujarat in India as part of a Rotary International Group Study Exchange (GSE).

During his visit Graham, a Senior Regulatory Affairs Executive at Cornwall-based TRAC Services, visited a number of healthcare-related projects including the Jaipur Limb Centre where prosthetic limbs are specifically made and fitted for patients the same day they arrive. On average these limbs cost US$25, but at no charge to the patient. Graham also visited an “eye camp” where surgeons give their time for free to operate on cataract patients, as well as pharmaceutical and nutraceutical manufacturers to discuss the booming Indian market.

‘It was a fantastic once in a lifetime experience. The trip also coincided with the announcement that India had been officially removed from the list of polio-endemic countries. This was a significant achievement and it was great to be able to be involved in the events that were organised to celebrate this,’ said Graham.

GSE was established to aid personal, community and international development and offers a unique cultural experience to young business professionals. Graham was hosted by Rotarian families and visited dozens of community development projects and spoke to organisations about his life and work in Cornwall.

NEWTOPRAMEMBERSTOPRA welcomes the following new members who joined recently.

TOPRA member Graham Donaldson recently spent six weeks travelling

Owen Farrugia - A sad loss to the professionThe Malta Pharmaceutical Association announced with deep regret the death of its co-founder, Owen Farrugia. As a TOPRA member, Owen contributed to the Regulatory Rapporteur as our Malta correspondent.‘The Pharmacy Community has lost a great pharmacist who passed away at the young age of 38,’ the association said. ‘Yet his contribution to pharmacy was

highly signi� cant especially to the area of Regulatory A� airs and teaching.’ Owen dedicated his life to ensuring the availability of safe and e� ective medicines to patients.

‘He disseminated his ideals of integrity and of putting the patient in perspective in pharmacy practice by his saying that “the patient is � rst”,’ the association said.

He held roles as a pharmacist in the Government Pharmaceutical Services, the Medicines Authority, and at Associated Drug Company as a drug regulatory a� airs scientist.

TOPRA was also saddened to note the sudden passing of member David Jacobs, based in Basel, who died on 25 December 2011, following surgery.

www.topra.org/intouch

APRIL 2012

InTouch Editors: Jenine Willis, Greer Deal and Virginia Guellal

How to contact InTouchInTouch 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

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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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*Registered Member

Owen FarrugiaThe Malta Pharmaceutical Association announced with deep regret the death of its co-founder, Owen Farrugia. As a TOPRA member, Owen contributed to the Regulatory Rapporteur‘The Pharmacy Community has lost a great pharmacist who passed away at the young age of 38,’ the association said. ‘Yet his contribution to pharmacy was