The TOPRA NewsleTTeR – KeePiNg membeRs iN TOuch

April 2014

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

Dr Ian Hudson, Chief Executive MHRA; Dr Margaret Hamburg, FDA Commissioner; Greer Deal, InTouch Co-Editor and Director of Global Regulatory Services

TOPRA at the MHRA Annual Lecture TOPRA was well-represented at the mhRA Annual lecture, held at the Royal college of Physicians in london on 6 march. executive Director lynda wight was in attendance, along with Past-President Alan hunter and InTouch co-editor greer Deal.

The lecture was delivered by Dr margaret hamburg, commissioner of the us Food and Drug Administration (FDA), who offered her perspective on an international theme around the challenges presented by globalisation over the next 10 to 15 years.

spring has finally arrived! it was a pleasure to be out walking with the family at the weekend surrounded by all the spring flowers. i’m also looking forward to being more active now that we have lighter evenings.

i am delighted to note that TOPRA’s membership outside of the eu is growing. This clearly benefits us all as our global network continues to grow and develop. i’m also excited about a number of online developments we have planned. These will enable TOPRA members to access all online membership tools, allowing us to participate in international ‘social learning’.

TOPRA courses in the Far EastFurther interesting developments outside the eu include new courses to be held in china and singapore (see page 2). These will give our colleagues in the Far east an opportunity to experience the fantastic learning opportunities that our organisation offers to professionals throughout their careers. in addition, these sessions

will further promote TOPRA in this important region of the world.

The joint health Technology Assessment (hTA) event with the National institute for health and care excellence (Nice) in march was a great success. Although i was unable to attend i understand there was very lively discussion between speakers and delegates throughout the two days and attendee feedback was very positive (more on page 2).

workshops like this highlight the importance for us in the understanding of all functions that play a key role in progressing medicines to the market. i look forward to hearing about and attending future events that help us develop our skill sets.

Finally, last month lynda wight and i attended empower’s Parliamentary Reception (see page 2), an event organised to encourage change in the drug development process. This followed on from TOPRA’s empower Roundtable event in February and the recent announcements from mhRA and emA regarding early Access

to medicines and Adaptive licensing, respectively. health minister earl howe delivered the keynote speech at the Parliamentary Reception, and this is available on the empower website via www.accesstomedicine.co.uk. Full details of the early Access scheme in the uK have been published on the mhRA website.

Overall it was a fantastic event to attend and support on behalf of our organisation. i was not surprised that the most powerful words spoken at the reception were delivered by patients and their representatives, once again highlighting that we must continue to remember how much impact we have on so many people’s lives with our knowledge and expertise.

JONATHAN TRETHOwAN, TOPRA PRESIDENTAs healthcare regulatory professionals we increasingly need to draw on knowledge from a global perspective, ensuring that our skills are shared and continually built on.

In this issue...

So spring has definitely sprung, and TOPRA is as busy as ever!

It’s great that TOPRA is reaching out to our colleagues in the Far East as well as increasing involvement in how medicines get to market. As our President says, we must continue to remember how much impact we have on so many people’s lives with our knowledge and expertise.

On that note, please don’t forget to submit your nominations for the TOPRA Awards: I’m sure you can think of at least one person or company who is a shining star.

Greer DealDirector, Global Regulatory ServicesCo-Editor, InTouch

Going beyond local boundaries

with participants from around the eu and the us, the workshop was well-attended and included both industry and national agency delegates. There was considerable debate in the breaks and at the end of the day, showing the keen interest in the topic by both delegates and speakers.

we heard from a number of companies along with the National institute for health and care excellence (Nice); the French hTA, haute Autorité de santé (hAs), the Dutch hTA, college voor Zorgverzekeringen (cVZ) and the european medicines Agency (emA) on their role with scientific advice.

Petra Jandova described how hAs is acting on behalf of the european commission with the project on shaping european early Dialogues (seeD) between hTA authorities. They wish to explore what can be shared and while they have enough volunteer pharma companies to take part, they still require device companies to try

A recent TOPRA workshop, held in conjunction with NICE, got to grips with HTA issues.

Mike Chambers, Head, Reimbursement and Value Demonstration, GlaxoSmithKline, UK

for scientific advice – for more details visit www.has-sante.fr.

Professor David barnett, a former committee chair of Nice, described the many points to consider when weighing up the balance of whether or not to recommend reimbursement. larry liberti of the centre for innovation in Regulatory science (ciRs) in the us also gave an insight into some research they are conducting on hTA across the globe.

The audience went away with a lot to consider – not only industry on how this will affect drug and device development programmes, but also hTA authorities on how they will work together going forward. Following the success of this workshop, we hope to develop and repeat it in future years.Christopher Bailey, Regulatory Intelligence and Training Manager, TOPRA

TOPRA inTouch Newsletter – April 2014

EMPOwER: ACCESS TO MEDICINE LOBBY OF PARLIAMENT, 25 MARCH, LONDON

TOPRA President Jonathan Trethowan (far right) and TOPRA Professionalism Committee member Claire Pomeroy (far left) at the Empower event in the UK Houses of Parliament

MORe quesTiOns than answers?

PATienT POweR receives strong support from pharmaTOPRA joined UK Health Minister Earl Howe, patients, families, campaigners and biotechs in support of the Empower: Access to Medicine campaign, for a hugely successful lobby of the UK Parliament in raising awareness for patient needs.

Patient organisations believe that their voice and engagement will make major, positive changes to priorities at several stages in the medical innovation process.

more than a hundred people, including TOPRA executive Director lynda wight and President Jonathan Trethowan attended the launch to explore the barriers and opportunities to earlier access to medicines.

The announcements of a uK early Access scheme by mhRA and an Adaptive licensing Pilot in europe from emA are seen as hugely positive steps forward by empower, who recently supported a TOPRA Roundtable event.

TOPRA is organising a course in EU Regulatory Affairs on 19–20 May in Singapore, organised in conjunction with the University of Hertfordshire and the Pharmaceutical Society of Singapore.

Two very experienced speakers with industry and MHRA (UK agency) expertise will give delegates a flavour of the key issues in this region with plenty of opportunity to ask questions and exchange ideas. More information on this course can be obtained from admin@pss.org.sg.

TOPRA travels to Singapore

CReD HTA wORKsHOP, 20–21 MARCH, LONDON

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA inTouch Newsletter – April 2014

Erik Smit and Christopher Bailey network at the 26th Annual EuroMeeting in Vienna, Austria.

26TH AnnuAL euROMeeTing, 25–27 MARCH, AUSTRIA

TOPRA Masterclasses are fast-becoming an important professional development option for senior regulatory professionals who want to deepen their understanding of regulatory topics.

So far this year, two three-day intensive, residential Masterclasses have attracted a wide range of senior regulatory delegates wanting either to extend their knowledge of the ‘US regulatory environment’ [4–6 February] or keen to get to grips with ‘Data requirements for abridged applications and specialised products’ [2–4 April].

These short-course delegates gain the benefit of participating in an academically accredited module taught by experienced lecturers – who are regulatory experts still working in their field. This ensures in-depth discussion and exploration of issues that senior professionals face as

topra ReACHes OuT

Attending events such as this one is important to ensure that TOPRA, along with its products and services, are known to a wider audience, and it benefits TOPRA members as our networks become increasingly widespread. exhibitions are also an excellent opportunity to catch up with friends of TOPRA old and new, both during the conference itself and at networking receptions such as the one organised by the clinical contract Research Association (ccRA) at the residence of the british Ambassador to Austria (see right).

Become a MAsTeR of your profession!

Nominations are nOw OPenHave you seen outstanding, innovative or inspiring work in regulatory affairs this year?with nine categories available including the two new additions of cONTRibuTiON and FuTuRes, you can ensure that an individual, team or organisation are recognised for their commitment to our profession. To register your interest in nominating and to view the available categories, please visit https://www.topra.org/awards2014.

wAnT TO HeLP?we are looking for volunteers to become Ambassadors who will spread the word and encourage nominations. by doing so they will promote excellence in the regulatory profession. 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 in london later this year.

if you would like to become an Awards Ambassador, email awards@topra.org and we will get back to you.

part of their high-level roles. As one delegate said about the US

course, it was ‘both informative and educational – this was a very good use of my time’.

Masterclasses are aimed at professionals with more than five years’ regulatory experience – those who are likely to be at the ‘driving’ stage of their regulatory career according to the TOPRA Careers Pathway – see www.topra.org/progression-pathways.

If this applies to you, the next Masterclass is 3–5 June and will cover ‘Product development, maintenance and commercialisation’. For more information, email kay@topra.org.

2014

TOPRA representatives Christopher Bailey, Regulatory Intelligence and Training Manager, and Erik Smit, Marketing and Communications Manager, had the pleasure of speaking to many people at the DIA Annual EuroMeeting in Vienna about what TOPRA can do for regulatory professionals.

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA inTouch Newsletter – April 2014

Our TOPRA in groups – based in Austria, sweden, switzerland, ireland, Portugal, italy, France and North America – all hold meetings for local members on a regular basis. with the help of our members’ expertise, we provide a vibrant forum for discussion.

belonging to a professional body such as TOPRA – with members based in over 50 countries across the globe – is a real benefit when it comes to sourcing local career information and supporting career development.

TOPRA in spain has been particularly active in recent months, holding two networking meetings this year and bringing many members together in the process.

both events took place at the centro de estudios superiores de la industria Farmacéutica (cesiF) offices

This meeting was an ideal opportunity for TOPRA members in spain to exchange experiences, while interacting directly with cesiF along with colleagues from different companies. building on this successful event, a similar meeting is currently in development for TOPRA in France, to be held in Paris.

Take advantage of this opportunity to meet with fellow regulatory professionals in your community by joining one of our member networks: please visit http://www.topra.org/networking.

i look forward to updating you all on the next stage of developments with your membership soon.

in barcelona and madrid, with discussion focused on two key areas. David gilbert, of David gilbert consulting, based his topic on ‘learning from why drugs fail to be approved’. The discussion was very informative and members came away with a thorough understanding of why companies invest in developing certain drugs but still fail in the approval process.

After some good interaction with the audience, sonia Juan of laboratorios sAlVAT discussed the ‘major regions of the world where marketing Applications are pursued.’ This discussion highlighted the increased number of product applications in certain countries and how the approval trends can vary across the globe. each discussion generated a lively response from the attendees, followed by an hour of networking.

Local learning on a global scaleIn this month’s column, Head of Membership Duncan Judd highlights what members can take from, and contribute to, their local TOPRA In group.

MEMBERSHIP NEwS

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 Registra-tion Numbers EU Des Reg nos. 000055553-0001 and 0002.

InTouch Editors: greer Deal, ishbel macDonald, graeme ladds and Jenine willis

Assistant Editor:Rachel cook

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 Rachel cook (rachel@topra.org).Please address any articles and correspondence to: intouch@topra.org or submit your contribution via www.topra.org/intouchViews 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

TOPRAbellerive house 3 muirfield crescent london e14 9sZTel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 e-mail: topra@topra.orgInTouch is free to TOPRA members. Annual membership of TOPRA is €225. TOPRA members can read or download InTouch online at www.topra.org

new TOPRA MeMBeRsTOPRA welcomes the following new members who joined recently

*Registered Member

Mr Nicolaj Donskov Nielsen, head of Regulatory Affairs, Vilas Pharmaceutical services, Ringsted, Denmark*Mrs Stine Kihl-Plambek, RA Professional, symphogen, lyngby, Denmark*Ms Johanna Horppu, Regulatory Affairs manager, lemu, Finland*Mr Norman Feuerstein, Regulatory Affairs manager, Vetoquinol sA, lure cedex, France*Ms Celine Rodier, Regulatory solutions consultant, Thomson Reuters, Paris, France*Dr Guglielmo Gallina, cRO Research Associate, Vetspin sRl, Ozzano emilia (bO), italyMrs Maria Effemey, Regulatory cmc manager, AstraZeneca, snackviken, sweden Dr Ferdinando Vegni, head of hematology/Oncology, celgene international sARl, boudry, switzerland Dr Hadia Chevallier, Regulatory Affairs Professional, Novartis consumer health, Nyon, switzerland*

Dr Jean-Yves Lecotonnec, ceO, Triskel integrated services, geneva, switzerland Mr John wiseman, Regulatory Account manager, AstraZeneca, macclesfield, uKMrs Shirley Hody, Regulatory Affairs executive, chiesi limited, cheadle, united Kingdom Miss Rashida Teladia, senior Associate, clinical Trial Regulatory leader, Jassen Research & Development, high wycombe, uK*Mrs Krupa Srivastava, Norgine ltd, Principal Regulatory Affairs executive, uxbridge, uK*Mr Shaun Simmons, Regulatory Affairs executive, Perrigo, barnsley, uKMr Garry Hassard, Development Director, med-Tek solutions ltd, winchester, uKMiss Toni Blumfield, maidenhead, uK*Ms Astrid Cornee, Regulatory Affairs Associate, Vertex Pharmaceuticals (europe) ltd, Abingdon, uK

Ms Muyibat Olaleye, senior Regulatory Associate, Allergan ltd, marlow, uK Mr Olumoroti Olowonyo, senior Associate, marlow, uKMr Kreshnik Hoxha, hull, uK (student)Miss Olawale Tijani, london, uK (student)Mrs Kellie MacLeod, senior manager site Activation, icon clinical Research uK ltd, eastleigh, uKMiss Fiona Goodwin, Regulatory writer, The clinical Trial company, Knutsford, uKDr Lisa Yule, Regulatory services Project manager, edinburgh, uK*Ms Kamaljeet Amrith, Regulatory executive, glaxosmithKline uK ltd, uxbridge, uKMr Manish Soni, Regulatory Affairs consultant, catalent Pharma solutions, swindon, uKMiss Suzanne De Montlebert, international Regulatory Affairs Associate 1, gilead sciences international ltd, cambridge, uKMr Ita Ekhaletruo, lancaster, uK (student)

Dr Eric Tse, Nottingham, uK (student)Dr Tina Narendra Nathan, cmc Regulatory consultant, east grinstead, uK*Mr Franco Perrina, senior Associate european Regulatory Affairs, Allergan ltd, marlow, uKMrs Aderonke Ajidagba, london, uK*Dr Simon Bishop, Junior medical writer, clinical Network services (uK) ltd, st. Albans, uKMr Samit Kumar Patel, Director, Pharmareal consulting services ltd, harrow, uK*Miss Joanna Olejnik, information & governance Officer, london, uKMr Aaron Tetteh-Ahinakwa, ceO, Pharmaceutical Reg & compliance group inc, walpole, usA