K e e p i n g y o u

In this issueLondon 2012 will forever be remembered for making this mammoth event the ‘People’s Games’. It could never have been achieved without good leadership, direction and excellent planning. So remember to cast your vote for the Regional Director for Europe to join the 2013 TOPRA Board ensuring continued ‘good leadership, direction and excellent planning’. Our TOPRA President, David Jefferys, quite rightly draws a parallel between modern Regulatory Affairs professionals and Olympic athletes. The skills needed for both disciplines are very similar but Olympians tend to make news headlines and Regulatory Affairs professionals don’t! So this is one reason not to forget the TOPRA Awards Ceremony in November where often unsung heroes will be recognised for their achievements – perhaps you’ll be in line for a medal? Finally, congratulations to all TOPRA members – you are all winners. Why? Because without your support, your knowledge, and your willingness to contribute and share with others, the Regulatory Affairs profession wouldn’t be the first class profession it is today.Greer Deal, Co-editor, InTouch

Sharing the Olympic spiritA message from David Jefferys, TopRA president

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 September 2012

the London Olympic Games of 2012 have been a great success. For those of us living in London and those privileged to attend the events, this has been a fabulous period with a unique atmosphere, great competition and wonderful sportsmanship. A time no one will forget.

hopefully, most TOPRA members were able to share in the spirit of the games, whether in person, through television or social media.

writing this editorial in the gap between the Olympics and the Paralympics, i thought it appropriate to reflect on some of the parallels and lessons for TOPRA. One of the greatest successes of the london games was the volunteers. The kindness, enthusiasm and good humour of the 70,000 people who worked very long hours was fantastic.

in TOPRA we are equally blessed by our wide range of volunteers without whose endeavours little would occur. The games have highlighted that the willingness to volunteer and to give time to organisations, is very much alive and strong. The success of the games was achieved through detailed planning, innovation and the pursuit of excellence. These values are equally evident in TOPRA.

we have our own major ‘Olympic’ event with the Annual symposium rapidly approaching in October. it also involves detailed preparation, new features and extensive planning. This year we can look forward to an excellent occasion in Dublin. i hope many of you will be in Dublin and will also attend our Annual Review which will take place alongside the symposium.

The Autumn sees a very full programme of events. we have the first of our Roundtable debates on the key topic of benefit–risk on 13 september. we have the emA meeting in November preceded by our Awards ceremony with a keynote lecture from Professor sir michael Rawlins.

Our Awards may not yet have the cachet of an Olympic gold medal but within Regulatory Affairs the evening is a key event – make sure you are there to celebrate the success of colleagues and to enjoy a great evening. i hope our Awards ceremony will have parallels with the closing ceremony of the Olympic games as we reward members of the regulatory profession who have contributed so much and advanced public health during the year.

Challenges aheadlike the Olympic athletes, we in the Regulatory Affairs profession have our challenges, and this period will be no exception as we face the implementation of the new pharmacovigilance legislation, the beginning of the Parliamentary and council debates on the new clinical trials regulation and the revision of the medical devices legislation.

The Olympic motto is ‘faster, higher, stronger’ which was introduced by the founder of

the modern games, Pierre de coubertin.

The modern Regulatory Affairs professional has to respond in similar fashion to the athletes. we are required to expedite and accelerate the authorisation of new medicines. we strive to introduce regulatory excellence models and maintain the highest standards with reduced resources and seek to strengthen our profession and the industries in which we work. Just as on the athletics track, we also endure our marathons, face our hurdles and make sprints to the finishing line!

As i write, thoughts are turning to the Paralympic games. in some respects, the Paralympics highlight even greater achievements. it is worth considering that all these wonderful athletes are only able to compete through the use of medical technology and medical devices.

with increasing numbers of our members working in the medical technology sector, we can perhaps reflect that we are playing a critical role in these games, and without our input many of the athletes would not be able to take part and, indeed, whole events would be impossible.

*Take a look at our olympic pictures on pages 4 and 5.

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

K e e p i n g y o u

While we wait for the shortlist to be announced in late September why not make a note in your diary to attend the prestigious Awards Ceremony on 28 November at the radisson blu Hotel, portman Square, London

tOprA Awards Update 2012

The Judges are Judging

Attendees to the Awards ceremony will also be invited to the inaugural TOPRA lecture given by Professor sir michael Rawlins which will take place before the Awards Dinner on 28 November.

tOprA Inaugural Lecturewe are delighted that Professor sir michael Rawlins will give the first TOPRA Annual lecture. sir michael has recently stepped down as chairman of the National institute for health and clinical excellence (Nice), a position he held from its formation in 1999.

Drawing on his experiences in clinical medicine, as a regulator and in the evolving discipline of health technology assessment, he will reflect on the question ‘is the regulatory profession fit for the future? why understanding regulatory procedures is no longer enough.’

in times of economic pressure, escalating development costs, increasing demands for transparency, legislative evolution and scientific revolution, he will consider how regulatory professionals need to be ‘future proofed’ to stay successful. what will be the key skills for a regulatory scientist in the future?

Register your interest in attending the lecture and the Awards ceremony at www.topra.org/Professor-Michael-Rawlins-Register.

AWArDS SpONSOrSHIp OppOrtUNItIeSThere’s still time to support the Awards through sponsorship. For those who care about regulatory excellence this is an ideal opportunity to promote your company in a commercially appropriate and highly visible new way!

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

pArN sUrveythanks to all the members who contributed to the research on e-learning issues undertaken by the professional Associations research Network (pArN). the final report has now been made available and gives a very clear idea of where tOprA members have similar needs and practices to members of the other professional bodies who took part, and where we are quite different! For example, 75% of tOprA respondents said that their continuing professional development (CpD) was funded by their employer, while this was the case for only 36% of other professionals.

Over two-thirds (69%) of TOPRA members had used some form of e-learning in the past 12 months. when asked for the reasons why they did e-learning 43% of TOPRA respondents said it was for cPD (vs 63% of others) while 67% of TOPRA members said it was for ‘another work-related purpose not part of cPD’ (vs 48% of others).

TOPRA would say that this ‘other purpose’ would be part of your life long learning in the TOPRA scheme and members should ensure that this is recorded as such. The most popular forms of e-learning for regulatory professionals were webinars (71%), slides with audiovisual accompaniment (62%) and online journals (55%).

The survey provided a lot of useful information on how professionals like to have e-learning delivered and their expectations in terms of time and costs. TOPRA will be using the information to help shape its e-learning offerings in the coming year.

in the meantime, please visit the TOPRA website to see presentations (slides and audiovisual) from key TOPRA meetings in the past two years, access soft skills e-learning courses and information on the basics course.online.

LOOking fOr some support?tOprA has revamped its Online Services Directory so that it is much more searchable, making it easier for you to find the service provider you need for your product, project or service.

Advertisers can set up and manage their own entries online, ensuring that their company or product information is up-to-date.

go to www.topra.org/services-directory to find out more or contact will@topra.org if you have any questions about setting up an account

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

POSiTiOn nOMinEE PrOPOSEr SECOnDEr (1) SECOnDEr (2)

preSIDeNt-eLeCt Jonathan Trethowan claire Pomeroy graham Donaldson matthew walker

regional DIreCtOr (Europe) Paolo biffignandi Axel wenzel michael Rasig Antonia Orsi

regional DIreCtOr (Europe) Aaron cousins Neil Armstrong John Deavin maria mehlin

regional DIreCtOr (Europe) Aine Kane Nick sykes stuart Finnie mahlet Negussie

regional DIreCtOr (Europe) shekhar Natarajan Jonathan Trethowan Yasmin de Farier Krim shirley elworthy

regional DIreCtOr (North America) Patricia Duchene monique garrett carlos langezaal christopher griffett

three posts for next year’s tOprA board of Directors became vacant this year: president elect and the two regional Directors (for North America and europe). by the due date, the nominations (listed in the box below) were received for the three positions that will fall vacant at the end of the current board term.two posts have been filled unopposed but an election is necessary for the regional Director europe.

TOPRA has been named by cogent’s National skills Academy (NsA) as its centre of excellence for Regulatory Affairs. This will help TOPRA offer regulatory education opportunities to a wider range of people in pharmaceutical manufacturing. in particular, TOPRA’s basics and introductory courses will now be more accessible to production and quality assurance personnel in a wide range of companies.

cogent works with a number of big pharmaceutical companies, such AstraZeneca and glaxosmithKline, as well as some smaller medical biotechnology companies.

many TOPRA courses will now be validated by the NsA and they will be recommended through its business referral service as well as being highlighted on their website, see (http://nsa-ccskills.co.uk).

What is Cogent?it is the uK’s industry skills body for chemicals, pharmaceuticals, nuclear, oil and gas, petroleum and polymer businesses, and it has a key role in meeting the skills needs of emerging technologies.

As an employer-led, government-funded sector skills council (ssc), it works with industry to research and forecast skills required and develop fit-for-purpose standards and qualifications and other skills solutions.

cogent’s gold standard education and training brand has now been accepted by the european chemical employers group (ecRN), which adopted this as the standard of competence for the industry.

elected unopposedThere was one candidate for President elect, so Jonathan Trethowan is elected unopposed and will take up this position from 1 January 2013. There was also one candidate for the Regional Director, North America and so Patricia Duchene will take up this position on the TOPRA board from 1 January 2013.

we congratulate Jonathan and Patricia on their appointments and look forward to their leadership in 2013.

Vote now!An election is needed to decide who will be the Regional Director, europe and we invite all members, Registered members and Fellows (including Retired) to cast their votes by visiting www.topra.org/topra-board-elections-2012-voting-form.

in order to help you make your selection, the candidates have provided a brief summary of their intentions in standing for

make your TOPRA vote count!

tOprA is named as a Centre of excellence for regulatory Affairs

TO PR A B OA r D E L E C T i O n S FO R 2 013 se ssi O N

election and these are also available to read on the website.Votes will be automatically counted but all votes will be

checked to ensure that they have been submitted by an eligible paid-up member and that each member has only voted on one occasion. Your vote, however, will be treated as confidential and reviewed only by our nominated Returning Officer.

Your vote must be received by 6pm uK time on Friday, 21 september, 2012. late votes will not be counted.

Please note that honorary life members, student members, web affiliates, or members of the TOPRA linkedin group who are not also paid-up TOPRA members, do not have voting rights.

resultsThe results of the election will be announced at the Annual Review meeting on Tuesday, 2 October, 2012, which this year will be held as part of the Annual symposium in Dublin, ireland.

September 2012

K e e p i n g y o u

Top: Olympic Rings at St Pancras Station welcome visitors to London. Middle: Erik Smit in the Olympic Park. Bottom: Sue and Alan Hunter with an Olympic torch.

With a month to go until the Symposium opens on 1 October, the preparations are almost complete.

We have added the final speaker* to this year’s programme, the last exhibitors have signed up and delegates keep flooding in. Bucking the economic trend, we have had more early bookings so far than any other year at this time. All this means that TOPRA is very confident that the upcoming Symposium is going to be the best ever. So if you haven’t booked yet, don’t leave it too late!

With the exceptional cooperation of the Irish Medicines Board, the working party, which consists of your fellow members from both agencies and industry, has been able to produce an excellent range of sessions packed with high-level speakers, key topics and exceptional networking opportunities.

The parallel Symposia on Medical Devices and Veterinary Medicines are also going from strength to strength. Both are now 1.5 days long, giving you more opportunity to hear about the topics that matter from the people who are making a difference to these specialties.

This year, due to popular demand, we have brought back the SME Day – on 1 October. It has been especially designed to provide information and answers to

the issues facing small and medium sized companies in our industry.

This year we have introduced a number of new parallel sessions for the first time. The IMB will lead a series of sessions on 2 October, which will appeal to local industry, covering:

● Compliance with Marketing Authorisations

● Herbal Medicines Regulatory Update● Developments in Pharmaceutical

Quality ● Common European Submission

Platform (CESP).

On the Monday and the Wednesday we will also be running workshops hosted by some of the exhibitors.

For more information and to book your place, visit www.toprasymposium.org or look out for any of the upcoming news alerts. You can also keep up to date through our LinkedIn groups.

erik Smit, Marketing Manager

regUlatory leaders debate benefit–risk issuesthe first tOprA roundtable for regulatory leaders, this time on benefit–risk, will take place on 13 September.

Attendance to Roundtables is by invitation only to senior members of the profession and the events are a great opportunity for leaders in the profession to network with peers and get to the nub of the issues in a constructive way.

look out for a post-event summary of the conclusions and recommendations in an eNewsletter. if you would like to contribute your ideas at a future event, please contact lynda@topra.org.

barcode changes to medicines packagingmembers based in the Netherlands can find out more about a number of changes to barcoding that are on their way at a RegNed Autumn meeting on 13 November. The meeting is entitled ‘is our packaging ready for the future of barcoding?’

RegNed, a subdivision of the Dutch Association of Pharmaceutical medicine (NVFg), will be exploring the issues with guest speakers from gs-1 and Z-index.

For more information go to http://nvfg.nl/Geledingen/Regulatory-Affairs/Meeting, or contact info@nvfg.nl.

set for successDublinSymposium 2012The 9th TOPRA Annual

* in case you are wondering, Sinead Curran, gCp/pharmacovigilance inspector, irish Medicines Board is the last speaker to be confirmed. Her topic will focus on pharmacovigilance hints and tips as part of Session 11.

The Games have been acclaimed as a great success, in no small part due to the welcoming atmosphere of the volunteers helping to deliver the events. We’re proud to say that some TOPRA members contributed in this way as ‘games makers’.

Past President and Chair of the TOPRA STAR Panel, Alan Hunter, was a games maker working in the Event and Services Team at the Olympic rowing and canoeing events that took place at Eton Dorney to the west of London.

‘The experience was magnificent but the 6am shift starts were a little wearing,’ he laughs.

Alan’s wife, Sue Hunter also volunteered at Eton Dorney as an anti-doping chaperone.

Several of our staff members were fortunate to secure tickets to various events both at the Olympics and Paralympics. And the docks surrounding Canary Wharf became the mooring place for a number of very impressive ‘super-yachts’ (pictured).

Let us know if you have any Olympics-related pictures or stories to share with TOPRA colleagues. Please email stories or pictures to intouch@topra.org or you can send them via the InTouch website.

at the heart of the action

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This issue is very much an Olympic

celebration, and TOPrA has felt at the heart

of it all with our headquarters being near

the Olympic Park in East London. During

the Olympic period itself, the Canary Wharf

area was very quiet as many businesses had

decided to alter their working plans in case of

travel congestion, however the TOPrA offices

were open for business as usual

K e e p i n g y o u

nEWTOPRAMEMBErSmiss Kathryn bishop, Actavis, barnstaple, uK*

miss Karima Debar, london, uK (student)

ms Anne Deblock, basel, switzerland (student)

Dr madlyn Denyer, billingshurst, uK*

Dr Dolores edmont, l2D consulting 34, les matelles, France

mrs Cheryl english, herne bay, uK*

ms Sylvie Gelebart, ucb Pharma, brussels, belgium*

ms Jolanta Golec, midleton, ireland (student)

ms Irene Gow, core clinical Research and consultancy, ireland*

ms martina Hoeth, baxter innovations, Vienna, Austria*

Dr Shinobu Iwai, cellseed, shinjyuku-ku, Japan

Dr tamara Lezhava, Arlington, us

mr manos mavromatis, shire, switzerland*

Dr Christian monnerjahn, salutas Pharma, barleben, germany

miss Frida Olsson, Pierre Fabre, winchester, uK

mr Kamlesh patel, greenford, uK*

mrs Avani patel, london, uK*

mrs Anna ponten-engelhardt, AstraZeneca, sodertalje, sweden*

mr Julien raynaud, Kloten, switzerland (student)

mr Arjun Singh, mi3, blackburn, uK*

TOPRA welcomes the following new members who joined recently.

Virginia and her daughter at the Race for Life event.

TOPrA Staff

WHO’SWhoA series in which InTouch profiles members of TOPRA’s office team

Sarah Roberts Purenins – Senior Conference Coordinator

sarah joined TOPRA as a temp before taking up the permanent role of meetings coordinator in April 2006. sarah currently manages meetings logistics including delegate registrations and venue and meeting liaison ensuring that TOPRA events run smoothly.

in a previous incarnation, sarah managed the membership and conferencing section of the london court of international Arbitration (lciA). sarah was responsible for organising seminars and conferences in Australia, brazil, china, england, germany, hong Kong,

the Netherlands, south Africa, spain, switzerland, and the us.sarah looks after the following activities:● logistical management of all courses and

conferences● Venue identification and liaison

(audiovisual, catering, rooms, etc)● Delegate bookings and liaison● speaker logistical requirements● meetings statistics● Feedback from meetings

contact sarah for: booking for meetings. email: Sarah@topra.org.

Virginia Guellal, InTouch co-editor, took part in the richmond 5K race for Life (Cancer research UK) with her five-year-old daughter Nora on 15 July.

rACing For LifE

Virginia says: ‘it was a great day. After raining for months, we had a break from the rain on that day and even enjoyed a bit of sunshine. we raced in memory of my aunt who died of cancer in may and i was really proud of my daughter for the effort she put in to complete the circuit in less than an hour.’

‘we hope to take part again next year. it is a good cause and, even though it is too late for my aunt, i hope, with the help of pharmaceutical companies, a cure will be found for future generations.’

www.topra.org/intouch

September 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