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K E E P I N G

Y O U

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

Prize presentation In July, TOPRA Executive Director, Lynda Wight attended the graduation ceremony of the Welsh School of Pharmacy (Cardiff University) to present a prize on behalf of TOPRA for the best overall performance in clinical and pharmacy practice throughout the MPharm course. The winner in 2011 was Kate Weston.

S EPTEM B ER 2011

Reflections on a busy year Zubair Hussain Message from the President It seems incredible to think that I took office last October at the Annual Review meeting held as part of the London Symposium and I am already writing my final column for InTouch as President of TOPRA. By the time you read this, elections will have closed and we will know who will make up the new TOPRA Board from October 2011 under our new President Dr David Jefferys. At the Annual Review meeting on 8 September I will report in detail on our successes and challenges – please come along if you can. Although the time seems to have flown by, when I reflect on the achievements in the past year, I am amazed at what has been accomplished. For me the year started on a high with our Symposium in London with the MHRA, with its record-breaking attendance, and our very first TOPRA Awards celebration. I am looking forward to the 2011 Symposium in Rome with the co-operation of the Italian agency, AIFA, and a repeat of the Awards later in the year in London. Both these events bring great credit to TOPRA and, most importantly, to the profession of Regulatory Affairs and its role in successful product development. I hope I will see many of you at either or both of these events.

The process to set up ‘TOPRA In…’ groups across Europe and in North America has moved forward by leaps and bounds in 2011 and my hope is that more TOPRA members will be actively engaged with us through these local groups and gain added benefit of membership by being involved. I have also been impressed by the success of our on-line ‘Basics’ training course, which has expanded our training offering to more people across the globe. I will derive great pleasure from the enrolment of our first PhD student this year. As President I have been pleased that we have continued to develop our relationships with agencies, with the Commission, trade bodies and other professional organisations and so our external profile has continued to be high. However, I am also pleased that this year we have looked at our internal processes as well. In the past year we have refined our strategic planning and I have followed the lead of previous Presidents by reporting on our

progress to the entire membership in the pages of this newsletter. We have developed a Statement of Values for all members to sign up to in 2012 and we have looked more closely at how we are organised and managed. In the coming months more information on the structure of TOPRA, its staff and committees will be made available to all members so that the breadth of our activities and the amazing diversity of what we are doing ‘behind the scenes’ can be appreciated more fully. I would love to hear from any member who has comments and ideas on how we can continue to grow and improve this organisation of which I think we can be justifiably proud. I would like to thank my fellow Board members for all their help and support in the last year. It has been a pleasure to serve as your President and I look forward to continuing as Past-President in the next session.

Board elections The invitation to all TOPRA members to vote for their Board representatives was issued at the beginning of August and, at the time of writing, votes were coming in daily. The results will be announced at the TOPRA Annual Review Meeting on 8 September at the TOPRA offices and we hope many members will be there to hear about TOPRA’s successes in the past year and plans for the future. The composition of the new Board will then appear on the website and in the next edition of InTouch.


K E E P I N G

Y O U

T HE TOP R A N E W S LE T T E R – K E E P IN G M E M B E RS IN TO U C H

Awards Update

Shortlist to be announced soon The judging process for the TOPRA Regulatory Affairs Awards was drawing to a close at the time of going to press. It won’t be long before everyone who has nominated a colleague, team or company will find out whether their own regulatory star has made it to the shortlists of these prestigious Awards in the following categories: ● ● ● ● ● ● ●

Horizon Inspiration Innovation Support Education Communication Lifetime Achievement.

Don’t forget to look out for the shortlist announcement over the next few weeks!

Inspirational support TOPRA is delighted to announce that Thomson Reuters is sponsoring the Inspiration category of this year’s Awards on behalf of its regulatory intelligence solution, IDRAC. The Inspiration Award will recognise a special individual who has supported fellow regulatory professionals during the development of their career, perhaps as a mentor or manager. ‘We are very proud to be involved in this year’s Regulatory Affairs Awards celebration by sponsoring the Inspiration category, an award that recognises an individual who has motivated fellow regulatory professionals to produce outstanding performances in a rapidly changing pharmaceutical environment,’ says Claude Basset, Vice

President Content Strategy at Thomson Reuters. ‘Thomson Reuters has worked with TOPRA for a number of years, by providing students on the TOPRA MSc in Regulatory Affairs course with free access to IDRAC,’ he adds. The company joins other supporters of the Awards who are demonstrating their commitment to recognising the excellent work of the Regulatory Affairs profession through sponsorship. TOPRA would like to thank all our sponsors, who include Samarind RMS, which is supporting the Innovation category; NDA who, as Regulatory Affairs Awards Champions, are offering general support to the Awards; and our media partner Ash Communications.

Book your seat at the Ceremony The TOPRA Regulatory Affairs Awards winners will be announced at a glittering Awards dinner and Ceremony on Thursday 24 November at The Four Seasons Hotel in Canary Wharf. You can book your seat by going to www. regulatoryaffairsawards.org or contact awards@topra.org for full details and a booking form.

InTouch is going digital

Cowslips and TOPRA? Many of our first medicinal products have a plant origin, for example that common morning-after remedy Aspirin (Willow bark). But Cowslips! Well the first 100 Traditional Herbal Registrations (THR) in the UK have just been reached and this is the result of the implementation in the UK of EU Directive 2004/24/EC (the European Traditional Herbal Medicinal Products Directive). Although I didn’t realise when taking this picture of a wild cowslip (Primula veris) near my home in Gloucestershire, it seems the flower is used in nasal decongestion preparations. Why mention all this? Well we have been receiving a few queries from people about this new legislation, which came into effect on 30 April 2011 in the UK, and TOPRA is considering organising a short meeting on this topic in the autumn. It is likely we will look at what is covered by the new legislation, some case studies and practical issues surrounding quality. If you have an interest in this area or know of colleagues outside the normal regulatory arena who market herbal products then do drop me a line (christopher@topra.org). Christopher Bailey

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

Each edition of InTouch will now be produced as a digital edition as well as a pdf. If you are reading our September print edition, you should have received a link to the digital edition a few days ago. If for any reason, you didn’t receive an e-mail notification of this, please contact jenine@topra.org so we can ensure you receive your digital editions in future. From now onwards not all editions of InTouch will be printed and distributed with Regulatory Rapporteur, however you will still be able to receive your digital edition each month, which you can either view on screen or print off as required. One of the key benefits of a digital edition is that it keeps the look of the newsletter but allows a more flexible format, eg it can go up or down in size as required and the content can be hyperlinked to other information or more details on our website. We hope you enjoy InTouch in this new format. Please contact jenine@topra.org if you have any questions or comments.

Science to Market 2011

Annual Conference of the European Association of Pharma Biotechnology (EAPB) focuses this year on

Personalised Medicine and Companion Diagnostics combined with open technology transfer presentations and poster exhibition Berlin, 27–28 September 2011


All roads lead to Rome...

Coming soon: TOPRA webinars Have you thought about undertaking training in ‘soft skills’ such as negotiation, communication or leadership, but never been able to spare the time? Would you like to ‘dip a toe in the water’ to consider how these skills are relevant to you as a regulatory professional? Are you looking for something interesting and rewarding to do in your lunch hour? If the answer to any of these questions is yes, look out for our new series of FREE live webinars starting in October 2011. These webinars will be on a series of topics designed to help you increase your effectiveness both professionally and personally and will be led by our coaching partner, Four Pillars Coaching. Places will be limited and will be available exclusively to TOPRA members. More information to follow but please contact emma@topra.org to register your interest.

TOPRA webinars What is a TOPRA webinar?

Q&A

A webinar is a live seminar, which is delivered over the web. You dial in and listen to the presenter while viewing slides displayed on your computer screen. What are the technical requirements?

All you need is a phone and an Internet connection. You can attend from your desk at work or at home. What are the advantages of a webinar versus a traditional face-to-face seminar? As no travel time or expenses are involved, it can much easier to fit attending a webinar into your busy working week. TOPRA webinars will often be held at lunchtimes to enable you to attend with minimal disruption to your working day. Sessions will be short and concise, often lasting less than an hour. Participant numbers will be limited to enable plenty of interaction between delegates and speakers.

and this year that is because the key event on the regulatory calendar, the TOPRA Annual Symposium, will take place in Rome. Like Rome, this wasn’t built in a day – the Symposium Working Party along with the TOPRA office staff have been working hard to put together a fantastic two-day programme that promises many insights into the current and future key issues affecting the sector. In addition, we will once again have the Medical Devices Symposium on 13 October as well as the Veterinary Medicines Symposium on 17 October. Apart from the obvious attractions of the Symposium, you will also have the opportunity to visit one of the most beautiful cities in Europe with a history going back thousands of years. Indeed, the Romans were the first civilisation to introduce a programme of public health for everyone regardless of wealth, so it is highly appropriate that the Symposium visits Rome. This year, the event opens with a keynote address by Professor Guido Rasi, the Director General, Agenzia Italiana del Farmaco (AIFA), Italy and Executive Director Designate of the European Medicines Agency (EMA). It also includes a special session on the work of the Italian Competent Authorities, including AIFA, Ministry of Health and Istituto Superiore di Sanità and in general, the Symposium offers excellent opportunities to network with agency delegates both from Italy as well as other European countries. Other high profile speakers who will be there include: Martin Seychell Deputy Director General, DGSANCO Aginus Kalis Executive Director Medicines Evaluation Board, The Netherlands, and Chair of Heads of Medicines Agencies Management Group (HMA-MG) Mats Marfalt European Regulatory Affairs and Director CV/GI Portfolio, AstraZeneca, Sweden Spiros Vamvakas EMA Richard Barker Author on the future of healthcare and former Director General of UK Association British Pharmaceutical Industry (ABPI), UK Andrea Rappagliosi Vice President European Government Affairs, GlaxoSmithKline, Belgium June Raine Director of Vigilance and Risk Management of Medicines, MHRA, UK Daniela Melchiorri (CHMP member and member of the Eudravigilance Steering Committee). We are adding new speakers and programme items all the time, so for a full picture, go to www.topra.org/symposium2011 where you can also book your place. We look forward to welcoming you in Rome.

Help your SPIN be e-Group ready You may have noticed a new tab – e-Groups – at the top right-hand side of the TOPRA website. This is the tab for SPIN members to access their e-Group discussions – a much-valued benefit of SPIN membership, which allows for online networking and professional debate within the specialist TOPRA communities. The TOPRA e-Groups will be replacing the existing Yahoo discussion groups over the next few months. The first e-Group is now online. The RI SPIN group has just been migrated to the TOPRA website. We are about to start migrating other SPIN group discussions, but in order to do this smoothly and effectively, every SPIN group member needs to ensure that we have their correct contact details. You need to ensure that your e-mail address is correct in two places on our website. To do this, please go to www.topra.org and log in. Then:

Use the My Account button on the right (which will take you to the Members Portal tab)

Enter your e-mail address, scroll down and save – this updates your membership record

Select the Edit tab at the top of the page and enter your e-mail address here too and save. This is the e-mail address that the e-Groups will use.

If you would like to join the RI SPIN e-Group, please contact jenine@topra.org and enclose your membership number and e-mail address (which of course must match our e-mail records on the website). To find out more about the SPINs and the e-Groups go to www.topra.org/groups or e-mail spin@topra.org.

AUGUST 2009


K E E P I N G

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S EPTEM B E R 2011

Fellowship

InTouch Editors:

Did you know that TOPRA has around 200 members who have been with us for more than TWENTY years – and many more who have been members for over ten years! Many of these professionals have made an outstanding contribution to the world of Regulatory Affairs – either through TOPRA involvement or work with trade bodies, training companies, universities or within their work place and would be eligible for Fellowship of TOPRA. Please think about your colleagues and which of them you could nominate. It really is an appropriate recognition for what they have achieved and they will appreciate it! If you need to check details or need help with the process please contact the TOPRA office on membership@topra.org.

Registered members Are you a Registered Member of TOPRA and thus entitled to use MTOPRA on your business card? At each membership renewal you are able to complete the declaration that allows you to be in this category so do be thinking about this now before you get your membership renewal invitation towards the end of the year.

Emma McNeely joins TOPRA We are pleased to welcome Emma McNeely to TOPRA as our Regulatory Training Executive. Emma’s main role will be the project management of the CRED (Continuing Regulatory Education) programme, in conjunction with the working parties, to ensure that TOPRA continues to deliver top quality regulatory education and training. She will also be developing TOPRA activities in the area of e-learning.

NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently. A full list of new members can be found at www.topra.org/intouch Mrs Sally Andrews South Devon Healthcare NHS Foundation Trust, Torquay, UK Miss Siama Aslam Hatfield, UK Miss Sara Ateiza The Co-Operative Pharmacy, UK Mr Brian Atkinson Medical Developments International, Melbourne, Australia Miss Leeanne Baker Kimal Plc, Bromsgrove, UK Mrs Sarah Bell Amgen Ltd, Uxbridge, UK Dr E Bradbury Perrigo, Dodworth, UK Miss Nabeela Butt AstraZeneca, Macclesfield, UK* Mr Daniel Capion Leo Pharma, Ballerup, Denmark Mr Oliver Cox Uxbridge, UK Dr Mehri Daryouzeh London, UK Miss Nichola Dingley AstraZeneca, Luton, UK Mr Michael Doroshuk Eisai Inc, Woodcliff Lake, US Ms Rosemary Downey Pfizer, Newbridge, Ireland Mr Will Drury Cyton Biosciences Ltd, Bristol, UK* Ms Nan Du Brierley Hill, UK (Student Member) Miss Sumitra Duvvuri Medreich Plc, Richmond, UK* Ms Janet Foulkes Bench International, Basingstoke, UK Ms Anne Frederick Novartis Pharma, East Hanover, US

Mrs Jenny Harry South Devon Healthcare NHS Foundation Trust, Torquay, UK Dr Jos Heuijerjans GlaxoSmithKline BV, Zeist, The Netherlands Ms Linda Huang Markham, Ontario, Canada Mr Irfan Hussain Recipharm Ltd, AshtonUnder-Lyne, UK Ms Rajani Jampana London, UK (Student Member) Mr Vikram Katragadda Lawrenceville, US (Student Member) Ms Grace Kearns Dublin, Ireland* Mr Mohammed Khankhara Transperfect, London, UK Dr Karla Knower Medical Developments International, Melbourne, Australia* Ms Marta Kollb-Sielecka Stiefel, Uxbridge, UK Mr Kalyan C Kothamasu Exeter, UK Ms Sophia Kourliouros Eisai Inc, Woodcliff Lake, US Dr Suren Kunanandam Ilford, UK Miss Suman Lall Esher, UK* Mrs Catherine Lambert Allergy Therapeutics Plc, Worthing, UK Miss Rachael Lattanzi Wockhardt UK Ltd, Wrexham, UK Dr Ching Li Edgware, UK Mr Karl-Heinz Loebel PharmaLex Gmbh, Mannheim, Germany*

Ms Trish Logie Woking, UK Mr Robert Lundberg Corona, US Mr Conor Maloney Balbriggan, Ireland (Student Member) Mr Raghuram Mamullapally Lloyds Pharmacy, Southampton, UK Ms Rajinder Mann Coventry, UK (Student Member) Ms Rebecca Marchant Johnson & Johnson, Maidenhead, UK* Mr Stephen Masters Allergan, Marlow, UK Miss Olivia McGregor Memphis, US (Student Member) Mr Peter Mescia Eisai Inc, Woodcliff Lake, US Dr Laura Millichamp Dolwyddelan, UK Miss Gabriella Mtseta-Zure Birmingham, Ireland (Student Member) Ms Joan Mutascio Pfizer, Madison, US Dr Stephanie Nadal Vifor France. Neuilly Sur Seine, France* Ms Gunilla Nordquist Medical Products Agency, Uppsala, Sweden Miss Eliza Okoira INC Research, Maidenhead, UK* Dr Mohamed Oubihi Woodley, UK* Mrs Lesley Paice Hyaltech Ltd, Livingston, UK Dr Andreas Marc Palmer Singen, Germany Miss Trisha Parmer Wokingham, UK

Miss Edolene Peters London, UK (Student Member) Mrs Kaisa Piipari London, UK (Student Member) Mrs Julia Plumb Gravesend, UK* Mr John Reynolds NDA Regulatory Science Ltd, Leatherhead, UK* Mrs Ylva Satrell Medical Products Agency, Uppsala, Sweden Dr Sebastian Sethe Newcastle Upon Tyne, UK* Ms Saadia Sharief London, UK Miss Rachna Soni The Co-Operative Pharmacy, UK Mrs Eleanor Stewart Aptiv Solutions (UK) Ltd, UK Ms Qin Sun Molnlycke, Irlam, UK Miss Lisa Taylor Focus Pharmaceuticals Ltd, Burton-On-Trent, UK Miss Cymone Thomas London, UK (Student Member) Mr Daniel Tyler Aptiv Solutions, Wooburn Green, UK Ms Sophie Viollet Eli Lilly & Company Ltd, Windlesham, UK Mrs Agnieszka Wilkins Pfizer, Madison, US Ms Jade Yee London, UK (Student Member) Ms Nadia Zegrour AstraZeneca, Macclesfield, UK *Registered Member

Michael Bangs, Greer Deal and Virginia Guellal

How to contact InTouch InTouch welcomes contributions from TOPRA members. If you would like to contribute to the newsletter, or find out about deadlines, please contact Michael Bangs (michael@topra.org) or 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. © 2011 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 €220. 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.

www.topra.org/intouch


TOPRA InTouch September 2011