K e e p i n g y o u

In this issueWe have another interesting and stimulating editorial from David. As he says, Regulatory Affairs is all about the patient and being transparent to the patient.

TOPRA is also committed to transparency in its corporate governance, and we have our elections to the Board next month (see centre pages). Don’t you want to get involved? It’s the perfect opportunity to make a difference to our business.

We also have more things to celebrate like the TOPRA students’ success in their MScs (page 2) and some of our members’ charity challenges (back page). Well done Phil and TRAC team!

Last but not least, our TOPRA Awards nominations deadline is at the end of this month. Please do participate in this important event for all Regulatory Affairs professionals by nominating your colleagues, teams or companies who are contributing to excellent regulatory practices and better healthcare for patients. It’s a virtuous circle!

Virginia guellal, Co-editor

Patient engagement is nothing new for the pharmaceutical and medical device industry and indeed is pivotal for developing our value propositions.

The more recent debate has been about involving patients in the regulatory decision process. Again, this is not quite as new as some politicians and commentators would like to have us believe. I recall many years ago introducing the first patient members to the then Committee on the Safety of Medicines and to the Committee on the Safety of Devices in the UK.

The Committee for Human Medicinal Products (CHMP) has established a patient working party and NICE has its important Patient Council. From July, under the new Pharmacovigilance legislation, we will see patient engagement in the decision-making processes of the Risk Assessment Committee.(PRAC). This follows the well-known phrase first used by HIV activists in the early 1990s, and frequently repeated during the recent NHS reform in the UK, of ‘No decision about me, without me.’

My personal view that it is only a matter of time before we see patient representatives sitting on the CHMP, perhaps supported by a patient

sub-committee. Given that patients are the consumers of life science products, this must be welcomed and should lead to a richer and more balanced debate over benefit-risk and acceptability of new products.

As Regulatory Affairs professionals, we need to be involved in this debate and TOPRA will be part of that. TOPRA has a long tradition of working with patient representatives and patient groups and this will be enhanced. We are currently engaged in discussions to take part in the important training initiative for patients to be involved in regulatory decisions (EUPATI – European Patients Training Initiative).

Transparency is closely linked with patient engagement. Earlier this year,

Transparency and patient engagementA message from David Jefferys, TopRA president

In this editorial I would like to share with you some thoughts around two related issues which have become pivotal for the life science sector, namely patient engagement and transparency.

EMA and HMA released an important policy document setting out their approach to the release of information within the European Regulatory procedures. As Regulatory Affairs professionals, we need to follow this debate and will no doubt participate as members of key functions within our companies/associations and in our day jobs.

TOPRA has long pursued a policy of sharing as much information as it can with our members. At the last Board meeting we took a further step to increase our transparency to you, the members with a new column ‘News from the Board,’ (page 3). Let us know what you think and what more information you would like to see. TOPRA is your organisation.

Calling our UK members in the North!You will have seen from previous editions of inTouch how successful the TOPRA In groups around Europe and North America have been. These groups exist to give a local networking opportunity for members and are complementary to our formal training programme and our online networking capability through the SPIN groups and LinkedIn.

This has spurred a few of you to contact us to find out if ‘TOPRA Scotland’ and ‘TOPRA North’ are still in existence and if you can participate. These two groups were very active a couple of years ago, but like everything in a membership organisation, require a core of motivated individuals to keep them going.

TOPRA is willing to help such groups re-start and give them the financial and administrative support they need. If you’d like to help out email membership@topra.org. We’ll make sure there are adequate resources available if a team can be got together.

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 JuNE 2012

TOPRA Staff

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

Christopher Bailey - Regulatory Intelligence and Training Manager

K e e p i n g y o u

The most important aspect of TOPRA is that it is run by members for the benefit of members, and the Board of Directors has overall responsibility for everything that TOPRA does.

Being a TOPRA Board member is a great accolade to the individual. It is also, by association, a tribute to the organisation he or she works for; demonstrating the value it places on regulatory professionals and the trust it has in its employee to take on the responsibility in addition to their daily work.

Many of you will be volunteers, either for TOPRA or another club or association, and will know that it is possible to balance these responsibilities – and to have a good time while doing so! It is also a personal development opportunity. You will certainly learn new skills being a Board Director and the opportunities to attend TOPRA conferences and meet senior professionals will expand your technical knowledge too.

The election process for three positions on the TOPRA Board (President-Elect, and two regional Directors) is now beginning with a call to ALL members to consider putting themselves forward. Nominations form are available on the website (www.topra.org/boardnom2012) and from the TOPRA offices and will be sent by email to all members.

Please think about standing for election. If you like what we do then come and be part of it. If you don’t, come and make a difference! If you’d like to talk to anyone about what’s involved feel free to email current Board members (addresses on our website) or the Executive Director (lynda@topra.org).

Congratulations to Claire Baynham who was awarded her MSc in Regulatory Affairs at the university of Wales graduation ceremony (see picture below) at the Millennium Centre in Cardiff on 4 May.

– could you make a contribution?ElEcTiON TiME

Claire is Manager of Regulatory Affairs at Eisai Product Creation Systems. She passed her MSc with a distinction for her dissertation on the subject of waivers to Paediatric Investigation Plans.

More graduatesOur congratulations also go to the other recent MSc graduates who were unable to attend the ceremony, they are:

● Sarah Fitzgerald (distinction)● Sharon Maglennon

(distinction)● Robert Schultz-Heinebrok● Sibylle Teuchmann

(distinction)

Those who gained a Postgraduate Diploma with distinction were:

● Monica MacGregor ● Patricia Whittaker

Those who gained a Postgraduate Diploma were:

● Elisna Maree ● Jane Moore ● Jason Thwaites ● Julie Twells ● Catherine Akers ● Marion Dahlke ● Anna Somuyiwa

Last but not least, Derek Martin passed his Postgraduate Certificate in Regulatory Affairs.

Christopher joined TOPRA seven years ago – almost to the day. His remit is to develop TOPRA’s Training and Conferencing programmes for the future. He works with the TOPRA Board, TOPRA office staff and TOPRA volunteers and regulatory agencies to create an annual programme of meetings in line with TOPRA’s strategic objectives and reflecting the external regulatory environment. To achieve this he manages the volunteers and TOPRA office staff to ensure these meetings proceed as planned, taking account of budgetary and other resource constraints.

Previously he has worked for the Medical Research Council, the NHS and within industry. His experience with Regulatory Affairs goes back over 20 years and includes local and global roles, mostly in the EU, but also US.

He has a BSc (Hons) Pharmacology and Biochemistry, a Diploma in Management Studies and a TOPRA Diploma in Regulatory Affairs.

What does he enjoy most about his role? ‘It’s a neutral role which bridges industry and agencies,’ he says. ‘I enjoy seeing the success of a new meeting.’ Time – shortage of – is his biggest challenge, he remarks.

In his free time, Christopher enjoys photography, gardening, old cars and any science-related subject. He is also active in his local community and is a parish councillor. He keeps up with his scientific specialty through continuing links with the Society of Biology as a committee member.

Christopher primarily works from an office based in his home but comes into the TOPRA Office once a week. ‘You can contact me about regulatory intelligence and any regulatory training ideas,’ he says. Just email christopher@topra.org.

TOPRA students celebrate success

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

TOPRA Staff

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

Christopher Bailey - Regulatory Intelligence and Training Manager

This is the first of an occasional column keeping you up to date with the discussions at the TOPRA Board meetings.

The TOPRA Board meets every other month at TOPRA HQ. The meetings follow a routine agenda with occasional special ‘guests’ on topics of interest. Here are the highlights from the May meeting:

● The 2011 annual accounts were approved and are available on the TOPRA website. The Board was pleased to note that cost controls and meetings success, particularly the 2011 Rome Symposium, have contributed to a surplus for the year. The Board also received a report from our investment manager showing that our retained funds had held their own despite the turbulent economic environment

● The Board reviewed its policy for protection of computers and the data held thereon

● The value of TOPRA membership to different sectors was debated with our PR consultant and a programme of research and refocus agreed to make sure TOPRA membership remains relevant and valued

● The Board decided that the elections for Board members should continue to be held in the Autumn and the results announced at the Annual Review meeting. However, it was agreed that it made more sense for the Board year to run in parallel with the financial year and so the new Board will be operational from 1 January each year

● The Board reviewed progress on the 2012 Symposium in Dublin which is shaping up to be an excellent and varied meeting. The 2013 Symposium will be in Portugal and planning is starting on this. Watch out for announcements for 2014!

● The next Advisory Council meeting will be in July and so the Board took some time to prepare the agenda – the outcome of discussions at the AC will be reported to the membership in due course.

NEWS

Category sponsors 2012

From the Board...

TOPRA Awards update 2012Beat the nominations deadline!

Time is running out to get your nominations in for this year’s Awards. To ensure that your regulatory ‘star’ isn’t overlooked go to www.regulatoryaffairsawards.org now and register your interest in nominating your colleague, team or company for the Awards.

REGISTER BEFORE 22 JuNE!There’s a category that will suit your regulatory ‘star’:

● HORIzON: Celebrating the ‘rising stars’ of the profession

● SuPPORT: Recognising companies that support the regulatory process in so many ways

● INNOVATION: Proving that Regulatory Affairs can produce innovative ideas & solutions to problems

● COMMuNICATION: Demonstrating the excellent communication, in whatever form, that is the cornerstone of regulatory work

● EDuCATION: Thanking those who ensure that regulatory professionals have the skills and knowledge to do their job well

● INSPIRATION: Acknowledging the leaders and those who have inspired us to do even greater things

● ACHIEVEMENT: Recognising exceptional contribution to the regulatory profession throughout a career.

The TOPRA Awards team is on hand to help with your nominations and answer any questions you may have. Look out for the FAQs on the Awards website, or leave your question on the Awards Hotline – +44(20) 7510 2578, or email awards@topra.org.

The TopRA Board for 2011-12. From L-R: Jonathan Trethowan, Aine Kane, Steve Brookes, patrizia nestby, niamh Lawler-Turner, Zubair Hussain, David Jefferys and Sarah Roberts. Monique garrett (inset picture) is the north America Representative who attends via telecon from the uS.

FellowshipWe hope you have all seen the information about the development of the Fellowship procedure to allow self-nomination. The criteria and form for Fellowship are the same; but now a member can complete it him/herself and get it countersigned by two colleagues (one of whom must be a Fellow already).

We think this will encourage more applications for Fellowship, as it is a more transparent process, and the applications will be of better quality. We have already seen an encouraging flow of questions and applications but would like to make sure that all members are aware of the change.

eCommunicationsWe are increasingly aware that some members are not receiving all the information that TOPRA issues via email as their corporate computer policies may be blocking our emails. It would help us a lot if you could check with your TOPRA member colleagues to see whether our TOPRA emails are recognised and let through. Members should receive the following as a minimum:

● Monthly digital version of inTouch● Daily TOPRA e-news● Regular TOP RA Jobs bulletin● Regular TOPRA member newsletters about events,

surveys and other information● Membership renewal invitations.

Please contact the TOPRA Office if you, or your colleagues, are not receiving all these communications.

Making the most of your membership

samarindRMSpharmaceutical software solutions

INNOVATION EDuCATION COMMuNICATION

K e e p i n g y o u

NEWTOPRAMEMBERSMiss Wumi Adenusi, London, UK

Mr Toseef Ahmad, Bury, UK

Mrs Fernanda Aleixo, Portugal

Ms Mary Alonso, Kennesaw, US

Ms Ama Agyaa Atiemo, Barking, UK

Mr Raghu Rama Raju Chiluvuri, UCB Pharma Ltd, Slough, UK

Mr Stephen Coney, Nottingham, UK

Dr Celine Courtay-Cahen, Cambridge, UK

Dr Karen Flynn, Biogen Idec, US

Mrs Shelley Gandhi, NDA Regulatory Science Ltd, Leatherhead, UK

Mrs Dawn Gbekor, PPD, Cambridge, UK

Ms Silvia Gomes, Celgene Europe Ltd, Uxbridge, UK*

Mrs Laura Hughes, Marlow, UK*

Ms Jill Jarusiewicz, Celgene Corporation, Berkeley Heights, US

Ms Lena Karlsson, Tarius A/S, Copenhagen, Denmark

Mrs Judy King, Regulis Consulting Ltd, Tring, UK*

Dr Elly Kourany-Lefoll, Serono, Vesenaz, Switzerland*

Mrs Tejas Kulkarni, Slough, UK

Ms Nathalie Langellier, Arrow Generics, London, UK

Ms Rachelle Long, Allergan Ltd, Marlow, UK

Mr Anthony McGuire, St Kilda, Australia*

Mrs Rizna Nisam, Maidenhead, UK

Dr Adjimate Noppado, Reckitt Benckiser Healthcare, Hull, UK*

Ms Brigitte Othmar, Cuxhaven, Germany*

Ms Marina Santos, Cabimer, CSIC, Seville, Spain

Ms Edel Shannon, Lucan, Ireland

Mr Par Tellner, EFPIA, Brussels, Belgium*

Dr Yves Tillet, White-Tillet Consultants and Experts, Chelles, France*

Ms Ciara Walsh, Labopharm Europe, Ireland

Mrs Yvette Warner, Gilead Sciences Ltd, Cambridge, UK

Mrs Victoria Watson, Dorking, UK*

Miss Astrid Woollard, Oxford, UK (student)

TOPRA welcomes the following new members who joined recently.

On Sunday 20 May, six members of the TRAC regulatory team donned their walking boots and raised over £600 for the ‘Miles for Macmillan’ campaign. Everyone on the TRAC team is an academic scientist who has helped support the licence approval of vital drug products that help prevent and treat a range of cancers.

As scientists their day-to-day role involves dealing with the scientific and technical aspects of understanding how chemical compounds react to cancers. This was one of the reasons TRAC wanted to get involved in the Macmillan fundraising.

[L-R] graham Donaldson, Hannah Mcneil, Sarah Trethowan, natalie Hann, emma Wright (Macmillan), Claire pomeroy, Jonathan Trethowan

Going the extra mile for

MacmillanWonderful, wonderful Copenhagen...TOPRA stalwart Phil Spalton completed his 18th Marathon in Copenhagen, in 25ºC heat in 4h 17min on 20 May, raising more than £1,250 for the British Heart Foundation.

Phil is so determined to reach his target of at least 20 marathons ‘before his legs give out’ that he has already committed to his 19th marathon in Chester in October. He says: ‘Each year I find the training harder than ever, so it makes sense, to me, to try for two marathons this year.’

He is really grateful to those many TOPRA colleagues who sponsored him. His website: www.justgiving.com/PhilSpalton-BHF, which has some photos of the race, will now stay open to accept further pledges to support that 19th marathon in Chester.

www.topra.org/intouch

JuNE 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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Tel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 email: topra@topra.org

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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