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T h e T O P R A N e w s l e tt e r – K e e p i n g m e m b e r s i n T o u c h
In this issue It’s the start of a New Year and already TOPRA has been very busy. TOPRA continues to listen to its members and keep an eye on trends within the healthcare industry. I, for one, am looking forward to seeing TOPRA’s revised strategy and its continued encouragement to undertake life-long learning. Certainly, it’s a sign of the times that online services will be more actively developed although the value of face-to-face contact must never be underestimated: some of the most successful businesses started life in a conversation over a drink! Don’t forget, if you want to continue being part of the TOPRA ‘family’, it’s time to renew your membership. Remember membership is a ‘two-way’ street: TOPRA gives a lot to its members but members can actively get involved and ‘make a difference’. As it is the New Year, I’d like to share with you a friend’s New Year wish: ‘For 2013 - here’s to more of what energises and inspires us and to less of what frustrates and devours us.’ Greer Deal, Co-editor
Jan uary 2013
Focusing on the future A message from Patrizia Nestby, TOPRA President
Following a highly successful 2012 for TOPRA, the 2013 Board has taken over with much eagerness to kick off afresh this year, taking forward a number of new initiatives and with a continued passion for healthcare Regulatory Affairs In the ever-changing environment of healthcare Regulatory Affairs, the TOPRA Board felt that the strategic direction for TOPRA needed to be revisited and a number of actions were identified at the last Board meeting (see report on page 3). A communication plan will soon be rolled out to share the revisited strategy with all members. As part of this, the valuable benefits of being a member of TOPRA will be highlighted. Of particular importance is that, unlike many other organisations, TOPRA is non-political and independent (with industry and agencies members) and provides a neutral platform for debate and life-long education. While firmly rooted in European Regulatory Affairs, TOPRA will further build on the ambition to increase the diversity of its membership to include a larger geographical spread, as well as different areas of expertise within Regulatory Affairs. An important presidential theme for 2013 is the development of high-quality online services. While recognising the irreplaceable value of face-to-face interaction and networking, it simply has to be accepted that the world
has changed in this respect. Due to budgetary restrictions, travelling and attending conferences and workshops are being increasingly restricted. In addition, the day-to-day work for many of us has been reduced to an increased focus on core activities associated with an increased workload, which sadly often has resulted in less opportunity to be involved in networking with peers and educational activities. TOPRA and its legacy organisations have traditionally been strong in providing forums for face-to-face interactions. Although this will remain an important focus for TOPRA through our educational programmes, conferences and Roundtable debates, the need to complement these events with high quality, up-to-date
and relevant online services will be realised. This will offer a very exciting opportunity to explore and develop innovative ways of interaction between members. It will also be an important way to further increase visibility, exposure and accessibility of TOPRA services to our members all over the world. Most importantly, the new Board intends to continue to express the passion we feel for healthcare Regulatory Affairs. We have a new year ahead of us with plenty of opportunities to promote our profession, to shape our environment, to challenge, to develop, to learn, to share… to make a difference. I wish you all a very successful 2013 and hope to see you at many TOPRA events and in TOPRA cyberspace.
Happy New Year! from all of us at TOPRA
Both the TOPRA Board and office staff are looking forward to a very busy year ahead! We have been discussing the business plan for the next few years and all members will begin to see the results of our deliberations over the next few months. We have further refined our Mission and Vision to more accurately reflect what TOPRA is and what we aim to be for our members in the future. See page 2 for more details on TOPRA’s goals for 2013–2014 and how we are planning to achieve them.
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T he TOP R A N e w s le tt e r – K e e p in g m e m b e r s i n To u c h
The year ahead for TOPRA
OUR GOALS FOR 2013 AND BEYOND
Following on from research among members and non-members at this years’ Annual Symposium in Dublin, we have defined our strategic goals for this year as: ● To effectively communicate TOPRA’s independent positioning, revised vision/mission and membership benefits to the worldwide regulatory community ● To become a respected provider of high quality and modern online ‘virtual’ services in order to increase accessibility of TOPRA services to members worldwide ● To grow and broaden the membership to include more international members and all regulatory affairs professionals including those from regulatory agencies ● To further develop TOPRA In Groups and evaluate partnering opportunities while ensuring that these are of clear benefit to TOPRA members ● To become a respected partner in facilitating debate on regulatory topics in a neutral environment for the benefit of the whole profession ● To develop and deliver professional development pathways for RA professionals and explore the possibility of TOPRA establishing professional standards for regulatory affairs.
What can you expect? Whoever you are – a regulatory professional, a policy-maker, a member of the general public, or someone else – you can expect us to: ● Be independent, representing our members as individuals irrespective of who they work for ● Speak out on regulatory affairs issues, in the interests of the whole profession ● Act proactively and keep on top of regulatory affairs developments ● Support our members in making the best possible contribution to their profession ● Encourage the development of a community of expertise among our members by helping them work effectively together ● Collaborate with others where we have a shared agenda.
Successful Strasbourg meeting Regulatory Affairs professionals from across the EU attended a meeting run by TOPRA In France in collaboration with the European Directorate for the Quality of Medicines and Healthcare (EDQM). The meeting, held in Strasbourg on 17 December 2012, looked at current regulatory challenges to maintaining active pharmaceutical ingredients (APIs). Pictured below are the delegates who also enjoyed a tour of the EDQM building and laboratory testing facilities. A more detailed report is on the website, see https://www.topra.org/toprafrance.
What are we planning for 2013? Early in the New Year we expect to be announcing a revalidation of the TOPRA MSc and developments in that course which will make it even more valuable and relevant to regulatory professionals. We are already planning the 2013 Annual Symposium in Lisbon, partnering with Infarmed, and we have a full programme of structured training courses and conferences that will meet the continuing professional development (CPD) needs of all members, at whatever stage they are at in their careers. Our local TOPRA In Groups continue to thrive and we are already talking to a number of partner organisations about how, working together, we can increase services and support to our members. Over the coming months you will see more information in InTouch and on the website, so do keep reading!
What can you do? In the meantime... don’t forget to renew your membership! All members should have received their renewal information with a range of easy options for payment. There are lots of reasons to remain a member of TOPRA, but one of the most important is that it signals to colleagues and employers your strong commitment to the regulatory profession and your being the best you can be in it! It also: ● Means you are part of a diverse global community of regulatory professionals with defined values and standards of good practice ● Offers you opportunities to be part of professional advocacy and to influence developments in regulatory affairs, by providing opportunities for you to contribute to consultations and policy discussions ● Enhances your career profile through opportunities for networking (face-to-face or online) with peers in the profession ● Offers access to expertise and practical advice through TOPRA networks whether virtual or face-to-face ● Drives your career development and CPD through life-long learning, structured training and education opportunities, drawing particularly on TOPRA’s unique expertise in European regulatory matters ● Supplies you with tools offering the latest information, analysed and interpreted in a way which is relevant to your work Every member matters to us – so please be sure to renew as soon as you can.
T h e TOPR A N e wsle tt er – K eepi ng memb e r s in To uc h
New TOPRA Fellows announced Congratulations to David Kane, Rachel Morten, Patrizia Nestby and Liz Gifford who have all been recently appointed as Fellows of TOPRA. Fellowship is open to those members with at least 10 years’ experience in Regulatory Affairs who can demonstrate that they have made a significant contribution to the profession through their work. This contribution can have been made as part of their employment, through TOPRA or in other activities, such as trade association committee work. Members can now submit their own Fellowship nomination, but it still needs to be supported by two other members (one of whom should be a Fellow). To become a Fellow of TOPRA signifies the acknowledgement of your peers of your professional contribution and allows you to add FTOPRA after your name. Visit the website or contact lynda@topra.org for more information on how to apply.
j an uary 2013
News From the Board... The Board of TOPRA is committed to operating in a transparent manner so that all members can be aware of what is being discussed and the decisions being made. Here is a summary of the main points from the Board meeting in November 2012. ● As this was the first Board meeting following the Annual
Honorary Life Membership TOPRA is honoured to include some of the most influential individuals in medicines regulation among its membership and to enjoy the support of many others. In recognition of this support, the TOPRA Board awards Honorary Life membership to some of these people and it is always a pleasure to be able to present them with their certificates at a TOPRA event. At the last TOPRA Annual meeting held with the EMA in December, [pictured from L–R] Past President David Jefferys took the opportunity to present certificates to to Richard Bergström (Executive Director of EFPIA) who has previously worked in industry and at the Swedish Agency) and Paolo Biffignandi (Past President of TOPRA). Congratulations to them both!
Review Meeting, the ‘transfer’ of responsibilities to the new Board took place, as well as formal processes of reconstituting committees, auditing the Board for skills and reminding Board members of their responsibilities in law. There is a vacancy on the Board which will be filled by ‘co-option’ at a future meeting. ● The Board believes TOPRA should develop its role as a
representative of the RA profession and as such should make contributions to public consultations where there is a ‘professional’ viewpoint. The Board recognises that making sure that any views expressed are representative of our broad membership is challenging and will be discussing the best way of achieving this at the next meeting. ● The finances for the year to date were reviewed and the
budget for 2013 was approved and will now be issued to Working Party and committee chairs so that they can play their part in keeping TOPRA on a firm financial footing. ● The Board considered feedback on the Annual Meeting
and the options for this meeting and other Board communications in the coming year.
Make your own New Year resolution – to record your continuing professional development with TOPRA LLL
● TOPRA is very gratified to have been approached by many
Why not make a New Year’s Resolution to start your own CPD log this year?
● The second half of the meeting was devoted to the strategy
The TOPRA Life Long Learning log is an ideal way to record all the many activities you do that contribute to your continuing professional development (CPD). Whether it is courses, volunteering, reading, on-the-job learning, mentoring or any other means of increasing your competency and skills you should be sure to keep a record that you can show to employers (current and future!) or clients to demonstrate that you are committed to currency and working to the highest standards. Visit the website (http://www.topra.org/lifelonglearning) for more information.
other organisations with a view to collaboration and there were discussions on the relative merits of the various opportunities. for TOPRA for 2013 and beyond. A set of six strategic goals were agreed (see page 2). Members are encouraged to ask questions on any aspect of the Board’s activity. We’d also like to hear from you what other ways you’d like the Board to interact with you. There are email addresses for Board members on our website and emails sent to lynda@ topra.org can also be passed onto individual Board members.
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Jan uary 2013
Congratulations
InTouch Editors: Jenine Willis, Greer Deal and Virginia Guellal
Congratulations to Amifa Tholley, TOPRA’s Events Administrator, who married her fiancé Armin Kamara before Christmas.
How to contact InTouch
Amifa joined TOPRA in 2011, and she helps organise and run our Basics and CRED courses throughout the UK and Europe. Amifa met Armin in December 2010. She says: ‘Both our parents were born in Sierra Leone, so on 8 December we had a traditional Sierra Leonean ceremony in my house, the aim of which is to officially introduce the two families to each other. Two weeks later we had the registry office marriage ceremony.’
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
TOPRA Board
Who’s Who A profile of new Board members
Patricia Duchêne - Regional Director (North America) Patricia Duchêne, Regional Director (North America) holds a PharmD from the School of Pharmacy of Grenoble (France) and has a Masters (DESS) in European Regulatory Affairs from the School of Pharmacy of Lille (France). She also holds a US and an EU RAPS Regulatory Affairs Certification (RAC). Patricia has spent her entire career in Regulatory Affairs. She started 12 years ago at Schering-Plough Europe, in Belgium. In 2003 she moved to the US, where she joined the Schering-Plough Global Regulatory Affairs group. After a few years on the East Coast, Patricia joined the Johnson &
InTouch welcomes contributions from TOPRA members.
Johnson’s Early Development Regulatory Affairs group in La Jolla, California, before taking up a post at Celgene Corporation, where her current role is Director of Regulatory Affairs. Patricia has been part of the TOPRA North America Leadership Team (NALT) for about two years after being an active member of the TOPRA South California chapter. She has most recently been the NALT representative on the TOPRA Regulatory Rapporteur editorial team. Patricia received a TOPRA Distinguished Service Award in September 2011.
Have your
Say!
The TOPRA Roundtable meetings are open to Fellows, Honorary Life members and other very senior TOPRA members. They are an opportunity for these leaders of the profession to engage in debate about the future of healthcare regulation. The most recent Roundtable was held on 10 January, at the Royal Society in London, when the guest was the MEP Marina Yannakoudakis, who is a member of the ENVI Committee of the European Parliament and is shadowing both the clinical trials and the medical devices legislation. This was a unique opportunity to hear about EU parliamentary processes and to feedback to a parliamentarian on the regulatory professionals’ view on how legislation is developed.
The UK Medicines and Healthcare products Regulatory Agency has launched a consultation asking for stakeholders’ views on its draft five-year Corporate Plan. It gives the strategic direction for the MHRA, setting out key challenges and opportunities, objectives and activities to respond to these, and outcomes it hopes to achieve. The consultation is open until 1 February 2013, if you would like to make your views known via TOPRA, please e-mail lynda@topra.org
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
TOPRA Bellerive House 3 Muirfield Crescent London E14 9SZ Tel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 E-mail: topra@topra.org 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.
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