K e e p i n g y o u

Adequate regulatory representation and input into project development teams can make the difference between untargeted inefficient and highly focused efficient development; no approval or approval.

Although it does sound obvious that a medicinal product or medical device should be developed according to a well-defined plan, it is astonishing that many project teams in pharmaceutical companies move throughout development with little consideration of requirements of the data package they are charged with generating. Project teams sometimes still embark on development of a product without a clear development plan, without having defined a target product profile (TPP) and without even considering drafting a regulatory strategy plan incorporating absolutely pivotal regulatory requirements and considerations.

Important aspects of the development plan, such as defining the unmet medical need/anticipated clinical benefit, the target population and indication, robust clinical study designs, the legal basis of the future marketing authorisation application and the optimal timing of regulatory interactions

are not considered in sufficient depth and often postponed with poor excuses.

Not surprisingly the result is usually significant inefficiencies, which may in part reflect the high number of medicinal products failing in late-stage development.

This is certainly an area where the regulatory professional can make a difference – a real strategic difference. By interpreting relevant regulatory intelligence at the early stages of development, by clarifying the end goal of development including the early shaping of the TPP and by proposing a regulatory strategy based on available product precedence and appropriately timed regulatory interactions across the globe. The regulatory professional is also often best placed to interact with relevant functions which may not be represented in the development project team, such as the market access

Take a strategic leadA message from patrizia nestby, TopRA president

Within the healthcare industry environment, providing strategic guidance to development teams is intrinsic to the role of regulatory affairs. As the experts in regulatory requirements, regulatory professionals have a clear focus on the end goal of clinical development.

function, including health technology assessment (HTA). Given the currently available options of parallel scientific advice with regulatory agencies and HTA bodies in the EU, a regulatory strategy should by default include a consideration as to whether exploiting these opportunities may benefit a product’s development.

This all sounds like common sense. Reality shows that for a variety of reasons, of which one simply may be the lack of in-house regulatory expertise, these basic principles are often not applied. This is an area where regulatory professionals could become more assertive: the end goal of drug development is to place a product on the market, a product which fills a medical need and which is accessible for patients. The important first step to establish this is regulatory approval and the regulatory professional is the person who is best placed to accomplish this.

Are you at risk... of losing your TOPRA membership?Over the past three months, TOPRA has contacted all members regarding their membership renewal and the final notice of lapsing has just gone out. If you haven’t received your notification, don’t be alarmed, you can renew quickly and easily by going to www.topra.org/renewals2013. And if you haven’t received your renewal notices – or any other emails from TOPRA recently – please contact membership@topra.org to update your details.

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 MARCH 2013

In this issueWinter is nearly over, thank goodness! It can be difficult to plan with the weather being so unpredictable but planning a product’s development plan, although challenging, should be more straightforward and definitely more rewarding!

In fact, I believe the role of the regulatory professional is essential to the ultimate success of a product. Our TOPRA President, Patrizia Nestby, gives us a very clear message on this subject.

As ever, TOPRA is at the ‘cutting edge’ and is embracing all things virtual with the support and guidance of their ‘A Team’. Now there’s no excuse not to keep up-to-date with TOPRA news and updates.

Finally, if you or your colleagues are shining stars why not nominate them for a TOPRA 2013 award as recognition of the difference they’ve made to our profession. Full details are in this edition of InTouch.

Virginia guellal, Co-editor

K e e p i n g y o u

TOPRA has two new additions to the Communications team who are both helping to improve our web, digital and social media communications. Both work three days a week in the TOPRA HQ in Canary Wharf.

D I g I T A l D e v e l O P m e N T s

Welcome to the A team!

First Joint TOPRA In event takes placeTwo ‘TOPRA In’ events were held on 22 Jan 2013 – one in Italy and one in Austria. It was no accident that both events took place on the same day – it was the first joint TOPRA In event. Italy and Austria took the opportunity to bring together around 50 regulatory professionals. After a brief introduction by Dr Antonia Orsi (chair TOPRA In Italy), Dr Daryl Rees (cEO salupont consulting) provided insights into the proposed clinical Trial Regulation scheduled for 2016 and highlighted critical steps and limitations, as well as new opportunities. Afterwards, Professor Paolo Biffignandi (cEO VI.REl Pharma) gave an interesting talk on ‘Adaptive Design for clinical Trials’ and how such an approach could change how clinical trials are run. After the presentations, a short Q&A enabled further discussion.

The Italian working party and the Austrian working party (chair Dr Elke Hofer-litzlbauer) were delighted that the joint TOPRA In event was so well received by all participants. For the organisers this event is seen as a way to stimulate knowledge exchange between regulatory professionals in neighbouring countries. we look forward to welcoming more and more like-minded people to the TOPRA In events all over Europe. Further details and regular updates are available on www.topra.org/topra-in.

Amanda little has taken on the role of Digital Editor and is concentrating on developing and restructuring the TOPRA websites. she is joined by Andrea mattis, who as communications coordinator, is helping on the web, raising our social media profile, producing our email newsletters and supporting our marketing activities.

Amanda is an experienced online editor who has led a number of multidisciplinary web projects. Her previous role was Online

managing Editor at the National Archives in london. she is a qualified web designer and has a first class degree in Philosophy.

Andrea most recently worked in the press team at the london 2012 Olympic and Paralympic Games as a media Executive for the london 2012

Festival. she has an mA in Political campaigning and Reporting from city University, in london.

Both Amanda and Andrea are keen to get to know TOPRA members and encourage more engagement with our web, digital and social media activities. Please contact amanda@topra.org if you would like to get involved with developing TOPRA’s web activities. It’s a great opportunity to help the TOPRA communications team produce the digital information and services that you need as part of your professional life now – and for the future.

If you have any feedback on our email communications or social media please contact andrea@topra.org and make sure you are following us on Twitter, Facebook and linkedIn for the latest information from TOPRA.

I T A L Y AUSTRIA

Virtual networking opportunitiesTOPRA embraces social media as an important tool for organisational and member engagement. TOPRA also encourages its volunteers to use social media in a personal capacity in order to reach out and share information and views with members and communities – both old and new. Please do actively participate in linkedIn or join us on Twitter, but don’t forget TOPRA now has its own eDiscussion groups for our sPINs based on the TOPRA website.

By joining a sPIN you can participate in online discussions with fellow TOPRA members knowing that you can share information or ask questions in a closed member-only environment. For more information on the sPINs go to https://www.topra.org/spin.

TOPRA has some guidance on using social media for volunteers and staff, which can be downloaded from https://www.topra.org/groups.

(R–L) Amanda and Andrea

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

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

l It brings international recognition of the work of the nominee and their employing organisation

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

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

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

since the Awards Programme began in 2010, we have 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 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 20 June 2013. 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:

l make them aware of the Awards – the categories and timelines

l Encourage colleagues to make nominations

l Think of worthy nominees that they could put forward themselves

l Help build up the excitement to the glittering ceremony we will hold on 27 November in london, UK.

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

AWARDSTIMELINESRegister your interest in entering the Awards – NOW!Closing date – Friday 20 June

Shortlist announced – mid-September

Awards ceremony – 27 November The TOPRA Regulatory Affairs Awards 2013 will be held in London, UK. Watch out for news updates on the event at www.regulatoryaffairsawards.org. The venue will be announced later.

TOPRA Awards 2013Nominations open on 11 March!

samarindRMS

gerald Thompson received the innovation Award in 2012

THE TOPRA NE wslE T TER – KEEPING mEmBERs IN TOUcH

Thank you to our supportersThe TOPRA Regulatory Affairs Awards could not take place without the support of our sponsors. We’re very pleased to say that samarind is supporting the INNOvATION category again this year.

‘ we’re delighted to continue our support for this significant and prestigious award for another year. Encouraging innovation is an intrinsic part of samarind’s ethos, and so it’s quite natural that we should encourage others to believe in, and fully develop their ideas,’ says samarind’s software Director miranda Pothiawala. ‘we look forward to continuing our valuable association with TOPRA and to presenting the Award to the winners, at what is now one of the key events in the regulatory calendar.’

If your organisation would like to align itself with the ethos of these Awards by supporting a category or the Programme in general, please contact awards@topra.org or contact TOPRA’s sales team – either by email mark.wilkins@ashridgecommunications.com or telephone: +44 (0)1753 714999.

www.topra.org/intouch

K e e p i n g y o u

MARCH 2013

This year sees TOPRA once again represented at the DIA euromeeting, taking place in Amsterdam on 4–6 march. As always, we’re hoping to meet as many of you as possible. Why not visit our stand to discuss how TOPRA can help with your career development, how you can get involved with TOPRA as a volunteer or simply to say hello? You will be able to sign up to courses online, buy our books or learn how to nominate a deserving person in the TOPRA Regulatory Affairs Awards. We look forward to seeing you in the low countries!

At the DIA EuroMeeting 2013 – on Stand 805

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.

© 2013 The Organisation for Professionals in Regulatory Affairs

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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.

NEWTOPRAMEMBERSMr Peter Larsson, Polypeptide laboratories Group, Glumslov, sweden*Ms Michelle Lee-Bourner, mylan Pharma UK ltd, sandwich, UK*Ms Danielle Liebaut, Elanco Animal Health, Vosselaar, BelgiumMrs Corinne Schmitz, Blue-Reg Pharma consulting, sophia Antipolis, France*Mr Paul Cronin, Diamond Pharma services, Harlow, UK*Mrs Cecilia Holland, AstraZeneca, macclesfield, UK*Ms Layide Akin-Fadeni, martindale Pharmaceuticals, Romford, UK*Mrs Peggy Cance, Blue-Reg Pharma consult, sophia Antipolis, France*Ms Laurence Garceau, Regulatory Par Excellence, Neutral Bay, Australia*Ms Alison Darbyshire, Bourne End, UK*Miss Claire Kinggett, Teva, Harlow, UKMr Kalle Purma, santen Oy, Viiala, Finland*Ms Kamaljit Kalsi, Abbott laboratories, maidenhead, UK*Miss Nina Langabeer, Norgine, Harefield, UKMs Tina Dedman, Teva Pharmaceuticals Europe, Harlow, UKMr Didac Marti, Eli lilly and company, windlesham, UK*Mrs Abisoye Olubodun, Dartford, UK*Mr David Purdie, Troon, UKMiss Rachel Forshaw, Fresenius Kabi, Runcorn, UKDr Ellen Smedts, EJ Exact, Klemskerke – De Haan, Belgium*Mrs Virginie Naish, Brentwood, UK*

Ms Caroline Brockis, Bolton Brockis consulting, weybridge, UK*Dr Elizabeth Heaviside, camberley, UKMrs Yogita Patil, Teva Pharmaceuticals Europe, Harlow, UKMr Paul Jaurnzems, mundipharma Research, cambridge, UK*Mr Andrew Corrieri, Pharmaconsulta – TmG services, Birkirkara, malta*Miss Shelley Browning, Boots Pharmaceuticals, Nottingham, UKMs Claudine Galea, Tayport, UK*Mrs Christine Roche, smith & Nephew medical, Hull, UK*Miss Leeanne Baker, Imed consultancy, chipping Norton, UK*Mrs Claire Kent, GlaxosmithKline, ware, UKMiss Mediah Iqbal, Dianne lee Regulatory consultancy, letchworth Garden city, UKDr Claudia Vincenzi, mylan Global Respiratory Group, sandwich, UK*Mr Christian Lidgey, Bishop’s stortford, UKMr Andrew Gemmell, Gillingham, UK*Ms Lesley Hoe, 3m Health care, loughborough, UKMiss Lindsey Griffiths, Fresenius Kabi, Runcorn, UKMrs Bosede Duru, london, UK*Mate Bartfai, IcON clinical Research, marlow, UKDr Pam Orchard, watlington, UK*Ms Isolde Krauss-Williams, wörwag Pharma, Böblingen, GermanyDr Sophie Houllemare, west malling, UK*Mrs Rebecca Cossell, london, UK*Mr Mark Wilkie, Fareham, UK*

Dr Miriam Halperin Wenlie, Actelion Pharmaceuticals, Allschwil, swtizerland*Mr Gordon Crowley, Novate medical, Parkway, Ireland*Mr Darren Thain, Tissue Regenix, York, UK*Mr Gbenga Olasehinde, Dagenham, UKMrs Loretta Lobo, ware, UKDr Shiva Neysari, Actelion Pharmaceuticals, Allschwil, swtizerland*Dr Gil Tomer, Unipharm, Israel*Dr Zoe Hindle, Emergent Biosolutions, wokingham, UK*Mrs Kattia Lonsdale, silva-corriga consultancy, High wycombe, UKMs Chintu Eapen, london, UK (student)Mr Vahidkhan Mulla, slough, UKDr Mark Griffiths, Pfizer consumer Healthcare, maidenhead, UK*Ms Meenakshi Ramasubramanian, Pharmalink consulting, maidenhead, UK*Miss Hajera Begum, Gillingham, UKDr Peter Abram, Reckitt Benckiser Healthcare, Hull, UK*Miss Lucy Pope, Norgine, Uxbridge, UKMrs Sharon Lambert, Norgine, Uxbridge, UKMrs Swapna Sridhar, Norgine, Uxbridge, UKMs Tochi Akubuko, Norgine, Uxbridge, UK*Mrs Tullett Aderonke, Hampton, UK*Mr Christian Naumann, munich, Germany*Miss Suzie Camp, liverpool, UK (student)Mr Vincent Steels, Tienen, Belgium (student)Ms Christine Sophie Schwaiger, stockholm, sweden (student)

TOPRA welcomes the following new members who joined recently

*Registered Member

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