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s eptem b e r 2013
T h e T O P R A N ewsletter – K eeping members in T ouc h
In this issue... Seeing the diversity of topics planned for the TOPRA Annual Symposium (see page 2) reinforces what I love most about my job – which is always dynamic, covers many facets of science, and is never dull. Our new Head of Membership, Duncan, talks of the forthcoming new member database and website on page 3. This is exciting news, especially if you can’t get to symposia or regular local meetings. I was impressed by the worldwide nature of the new members this month (back page) from the isles of Scotland, west to Canada and east to Russia and all points between. The leaves are turning here in Glasgow but I have always found Autumn to be a time of good changes – the Symposium, the Awards and plans for celebrations of 10 years are to come. Talking of which, we would like to hear about your memorable TOPRA moments. For example, did you meet your partner at a TOPRA course? Do we have any second generation TOPRA members? How has participating in TOPRA enriched your working life? Ishbel MacDonald, co-editor
A message from Patrizia Nestby, TOPRA President With most of us having returned from our summer holidays, now is the time we start planning our remaining activities until the end of the year and begin thinking about next year. The 10th TOPRA Annual Symposium will soon take place – and it is a fantastic achievement that TOPRA will be celebrating its first decade as The Organisation for Professionals in Regulatory Affairs in January 2014. I have been involved in the Symposium Working Party since 2005 and each time it has been a very rewarding experience. Not only has it helped me keep up to date with a wide range of areas in regulatory affairs, being part of the TOPRA community who bring together this great event and then meeting up with contacts and colleagues at the conference itself is a pleasure. Without any doubt this year’s Symposium will again be informative and enjoyable – to find out more see the article overleaf or go to www. toprasymposium.org. As part of the programme, the TOPRA
Board will give a presentation introducing who we are, what we have achieved so far and what the exciting near future will bring for TOPRA members. I do hope I will see you there in October. Next year, when TOPRA officially celebrates its 10th birthday, I shall be heading the Symposium Working Party and I look forward to hearing your feedback from this year’s event to help us make our plans for the 11th Annual Symposium, which is to be held in Brussels.
Watch this space Returning to our 10th birthday celebrations, we will be sharing news of how we intend to mark this special occasion over the coming months so please look out for announcements. The Regulatory Rapporteur editorial team is working on a 10-year timeline article noting significant events and regulatory
changes over the years. This is due to be published in the January 2014 issue. As a TOPRA member, please make a note in your diary to attend the Annual Meeting/ Extraordinary General Meeting(EGM) scheduled in the afternoon of the 27 November, preceding the TOPRA Annual Lecture and Awards at the Institute of Directors in London [see article on page 3]. In addition to providing an overview of the TOPRA strategy and finances, we will reveal the results of the elections for the vacant Board positions together with proposed changes to the constitution. With so much to look forward to in the TOPRA calendar, I wish everyone a productive and enjoyable rest of the year.
Doctoral developments TOPRA is delighted to announce that the contract for the TOPRA PhD in Regulatory Affairs has been signed with Cardiff University and that we already have interest from a number of possible students. This PhD programme is a research-based degree which can be studied part time over a 5-year period. Details of the terms and conditions and how to apply will be on the TOPRA website or available from our Postgraduate Administrator, Kay Wood (email@example.com). The photo shows TOPRA Executive Director Lynda Wight and Professor Sam Salek, Director of the Welsh School of Pharmacy Centre for Socioeconomic Research and Chair of Postgraduate Taught Board of Studies and Boards of Examiners of Cardiff University at the contract signing ceremony.
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TOPRA ANNUAL SYMPOSIUM 2013, 16–18 OCTOBER, SHERATON HOTEL, LISBON, PORTUGAL
Countdown to Lisbon There’s still time to book your place at the 10th TOPRA Annual Symposium 2013, which will be held at the Sheraton Hotel, Lisbon, Portugal from 16-18 October.
Don’t miss your chance to join key opinion leaders and regulatory professionals from the global pharmaceutical industry, government, regulatory agencies, and life sciences organisations on a neutral global platform. This year’s symposia, which include conferences on regulatory affairs in pharmaceutical, medical devices, veterinary and SMEs (small and medium-sized enterprises), feature 17 themes with more than 80 presentations.
Session themes include clinical trial regulation proposals; the new EU medical device legislation; health technology assessment and reimbursement; the impact of the International Conference on Harmonisation on drug development; the veterinary Variations Regulation; and falsified medicines. These presentations, along with end-ofsession panel discussions, will cover a vast array of hot topics.
Regulatory affairs in Portugal
The conference is organised in conjunction with INFARMED, National Authority of Medicines and Health Products, IP, Portugal, which will be leading a session on its role and
activities. As Pedro Faleiro, adviser to the Executive Board at Infarmed, told TOPRA: ‘Infarmed is in favour of increased transparency and communication – we use our website as the preferential vehicle for information. We make it our goal to publish as quickly as possible any information that we consider may have an impact on the activities of regulatory professionals and other interested parties to grant them predictability for their activities.’ Read the full transcript of this interview for an insight into the agency’s views on the latest regulatory developments at https:// www.topra.org/infarmedinterview.
Speakers TOPRA has secured a large number of experts from industry and agencies to keep you informed of the latest developments. They include: ● Erik Hansson, Deputy Head of Unit,
European Commission, Health and Consumers Directorate General
● Judite Neves, Diretora da Direção de
Produtos de Saúde Health Products Director, Infarmed, Portugal
● Bruno Flamion, Past Chair of the Scientific
Advice Working Party, European Medicines Agency (EMA), Past Chair of the Committee for Reimbursement of Medicines, Belgium, Professor of Physiology and Pharmacology, University of Namur, Belgium
Lenita Lindström-Gommers, Senior Policy Officer, European Commission Health and Consumers Directorate-General, Unit D5 – Medicinal products – authorisations, EMA
● Veronique Davoust, PGS Global Quality
Operations, Strategy, Pfizer, France
● Rosário Lobato, Associate Professor,
University of Lisbon – Faculty of Pharmacy, Portugal
● Flaminia Macchia, European Public Affairs
CALLING ALL STUDENTS!
Each year TOPRA awards a prize to the best student in clinical and pharmacy practice on the MPharm course at Cardiff University. This year the winner was Lowri Roberts seen here (below right) accepting her prize from Lynda Wight at the graduation ceremony.
with an interest in regulatory affairs TOPRA is inviting students studying in a relevant discipline to display a poster of their work at the Annual Symposium.
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Posters can cover any topic of interest to the healthcare regulatory community, such as in human or veterinary healthcare, pharmaceuticals, biotechnology or medical devices. Prizes will also be awarded for the best entries, to be announced at the start of the final day of the Symposium.
ins ’s S The Annual Symposium is a key event in the European calendar, offering her ear y t poster at las a topical platform for students to use this opportunity to engage with an audience of stakeholders. If your poster is accepted you will receive a free delegate pass to attend the Symposium; the perfect opportunity to discuss your work with judges and visitors alike.
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Marked by judges appointed by TOPRA, prizes will be given to entrants whose posters successfully and succinctly engage and describe a piece of planned or completed research to the general audience. As the Symposium is intentionally cross-disciplinary, you will of course be judged in part on your ability to represent your research to a broad audience who may not be experts in your field. If you would like to undertake this exciting challenge, submit your abstract of 50–150 words on the Symposium website describing the topic for your poster. Registrations must be received by close of business on 20 September 2013. Further information on the competition rules, entry requirements and key dates can be found on the website: https://www.toprasymposium.org/poster
For all the latest Symposium updates and booking information go to www. toprasymposium.org
NEWS FROM THE TOPRA MEMBERSHIP TEAM Head of Membership, Duncan Judd, gives the inside track on member developments in the first of his monthly updates Since joining TOPRA in May, the past few months have introduced me to the world of regulatory affairs. From speaking to attendees of several TOPRA In and SPIN events, I can see that TOPRA members are very passionate about regulatory affairs and their professional body. Encouragingly, they are very complimentary of TOPRA’s ethos and how it works to engage and bring the community of members together. One of the main strengths of TOPRA is its ability to facilitate neutral and independent discussion for members both in a face-toface and virtual context, providing members with a unique opportunity to participate in discussion and hear various opinions and perspectives. Members engage in discussion via the SPINs, which range from medical devices to CMC and veterinary science. And, after attending several SPIN meetings, I can see what a wealth of knowledge can be shared and how it helps members keep ahead in an ever-changing environment.
TOPRA has seen growth across Europe with an increase in members in Ireland, Switzerland and the UK . One of my strategic aims for the next few years is to broaden membership internationally by continually illustrating how essential it is to keep up-to-date with regulatory science whether you work with EU regulations or global regulatory affairs on a daily basis.
Make a difference
So how does TOPRA benefit you, I hear you ask? Well you can benefit not only by joining a SPIN or local TOPRA In network but also by volunteering. Members who volunteer to speak at courses or conferences or participate in their working parties often say this really boosts their opportunities. It also shows a dedication and commitment to healthcare regulatory affairs that often inspires other members to do the same. This helps TOPRA to continue to promote professionalism and provide high-quality training opportunities. Now we are in September, it’s a good
time to let you know of some of the developments that the office team and I have been working on. We are actively investing in our members and the professional body which you enjoy. In the next few months and throughout 2014, we will explain in detail the developments and improvements that will take place. One of the most significant improvements will be the implementation of a new member database and website at the beginning of 2014. This new system will allow you to engage and interact with other members, access information via your own ‘dashboard’ and store your own information on your account as well as access various other member-only benefits. If you want to know more about how to get involved or how to volunteer please e-mail me – firstname.lastname@example.org – or meet me in person at the Annual Symposium. I look forward to updating you all on the next stage of developments with your membership soon.
TOPRA REGULATORY AFFAIRS AWARDS 2013
COUNTDOWN TO THE AWARDS! It’s time to book your place at this prestigious event!
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Shortlists will be announced soon! Make sure you secure your place at the Awards Dinner and Ceremony so you can hear the winners first hand – and congratulate all the short-listed nominees. This year the Awards will be held at the prestigious Institute of Directors in London’s Pall Mall on 27 November. For full details and information on how you can secure your place at the ceremony and accompanying TOPRA Annual Lecture go to www.regulatoryaffairsawards.org.
Thank you to our supporters TOPRA is pleased to accept the support of two successful service providers within the regulatory sector who are committed to showcasing the best of regulatory affairs through the Regulatory Affairs Awards programme. ●
Samarind RMS, which is supporting the INNOVATION Award again this year. Samarind, a leading provider of software to the regulatory profession, won the Innovation Award in the 2010 Awards.
Clinical Professionals, a leading pharmaceutical research and development staffing business, is supporting the INSPIRATION Award this year.
No matter what the size of your organisation, it’s not too late to align your company with the ethos of excellent regulatory practice and help raise the profile of regulatory professionals. Go to www.regulatoryaffairsawards.org/ sponsorship or contact email@example.com for further details.
samarind RMS A ugust 2 0 0 9
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S eptem b e r 2013
ELECTIONS FOR PRESIDENT ELECT AND DIRECTOR POSITIONS
Your chance to stand for the TOPRA Board All members should have received a call for nominations to the Board for 2014. Please consider standing and making your contribution to your professional association. There is information on the TOPRA website, with nomination forms (https://www. topra.org/board-nominations-2013) and if you’d like more details about what might be involved please email firstname.lastname@example.org. This is a real opportunity to ‘put something back’ into your profession and can help increase your regulatory intelligence and raise your personal profile at the same time. You will also have received notification of the 2013 Annual Review Meeting on 27 November. This is your chance to hear a report from the current Board and to discuss their plans for the future of your organisation. This year the meeting will also include a brief EGM (Extraordinary General Meeting) to approve some minor changes to the TOPRA constitution. We understand that some members did not get the correct URL for the supporting documentation so they are repeated here for your convenience – https://www.topra.org/memorandum-2013. The Annual Review Meeting will take place on the same date and at the same venue (The Institute of Directors) as the 2nd TOPRA Annual Lecture and the Awards for Regulatory Excellence (see previous page).
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently
Dr Stephanie KrumholzBahner, Head of Regulatory Affairs, CYTOS Biotechnology AG, Switzerland* Dr Liz Pollitt, Senior Consultant, NDA Regulatory Science Ltd, Leatherhead, UK* Mrs Niamh Panesar, Manager, Regulatory Services, Kinapse Ltd, London, UK Prof Thomas C Kuhler, Vice President, Novo Nordisk A/S, Soeborg, Denmark* Ms Janet Murphy, Senior Regulatory Affairs Specialist, Mylan Institutional, Inverin, Ireland* Ms Regina Joyce, RA & Pharmacovigilance Manager, Meda Health Sales, Dunboyne, Ireland* Mr Venkata Ramana Mukkapati, Hounslow, UK* Mrs Jane Whitton, Operations Director, Blumont Healthcare Ltd, Grantham, UK Ms Anne Marie Martin, Regulatory Affairs Associate, Alkermes, Athlone, Ireland Dr Stephanie Tweed, Scientific Affairs Officer, Aspire Pharma Ltd, Petersfield, UK
Ms Claudia Fellmer, Manager, Clinical Quality Assurance, Crucell Switzerland AG, Bern, Switzerland*
Mrs Aileen Fisher, VP, RA CMC & Publishing, Kinapse Ltd, London, UK
Mrs Jane Watson, Regulatory Ms Aslihan Serbest, Regulatory Manager, Derby, UK* Affairs Executive, Boehringer Mrs Sheanesu Zishiri, Ingelheim Ilaç Ticaret A.S, Chatham, UK Maslak, Turkey Miss Karanjit Mudhar, Mrs Melek Onol, Head of RA & Birmingham, UK (Student) QA, Boehringer Ingelheim Ilaç Mrs Maria Christopulou, Ticaret A.S, Maslak, Turkey Manager Regulatory Services, Miss Ozlem Ozdemir, Kinapse Ltd, London, UK Regulatory Affairs Executive, Mrs Patricia Cleary, Senior Boehringer Ingelheim Ilaç Publisher, Kinapse Ltd, Ticaret A.S, Maslak, Turkey London, UK Miss Bhavana Kharay, Mr Stuart Goodall, Regulatory Affairs Officer, Sandwich, UK Merck Sharpe & Dohme Ltd, Potters Bar, UK Ms Humaira Qureshi, Harlow, UK Miss Mary Kay, Senior Consultant, London, UK Mrs Stephanie Snow, Salisbury, UK Mr Andrew Fox, Head of RA Europe & MEA, Onyx Miss Jam Angelie de Jesus, Pharmaceuticals Ltd, Regulatory Affairs Assistant, Maidenhead, UK* Slough, UK Dr Jacqui Cusack, Associate Miss Anne Dickie, Manager, Gilead Sciences Ltd, Stornoway, UK (Student) Carrigtohill, Ireland* Ms Rodgoun Attarian, Ms Anna Ohanjanyan, UK (Student)
Miss Kinali Vaghadia, Dr Stephen O’Hagan, Edge Hill, Regulatory Affairs Officer, Australia (Student) Edgware, UK Mr Vinit Pereira, Sydney Wharf, Mr Monpara Keyur, London, UK Mr Syed Qadri, Hounslow, UK UK (Student) Ms Belinda von Ebru Tonay Tatlisu, Boehringer Ms Anna Morozova, Director Regulatory Affairs, Regem Consulting Ltd, Reading, UK*
Niederhaeusern, Grenchen, Switzerland (Student)
Operations Assistant, Qdossier B.V, Waalwijk, The Netherlands
Mrs Melissa Smart, Wellingborough, UK
Miss Shalini Weerasooriya, Reckitt Benckiser Healthcare UK Ltd, Hull, UK
Mrs Sabine Galliker, DRA Director CMC, Actavis, Zug, Switzerland*
Ms Elsa Da Conceicao, Medical Lab Assistant, Ilford, UK
Mr Jose Falcon-Hernandez, London, UK
Dr Dominique Descamps, Miss Harini Bushan, Slough, UK Head Adult Vaccines Portfolio, GlaxoSmithKline, Wavre, (Student) Belgium Mr Toby Verlouw, Regulatory
Ingelheim Ilaç Ticaret A.S, Maslak, Turkey Mr George Collins, Pharmaceutical Assessor, MHRA, London, UK
Mrs Julie Taccoen Dionisi, Senior Regulatory Scientist, Voisin Consulting, Boulogne Billancourt, France Ms Peggy Levy, Senior Regulatory Affairs Associate, Duchesnay Inc, Blainville, Canada Mr Prasad Patil, Analytical Scientist, Q Chip Ltd, Cardiff, UK Miss Elisabeth Marchal, Regulatory Project Leader, MITHRA Pharmaceuticals S.A, Liege, Belgium Dr James Kitulagoda, Synthetic Organic Chemist, St Albans, UK Mrs Janet Cosgrove, Senior CMC Regulatory Specialist, USA*
InTouch Editors: Jenine Willis, Greer Deal and Ishbel MacDonald
Editorial support: Rachel Cook
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 Rachel Cook (email@example.com). Please address any articles and correspondence to: firstname.lastname@example.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. © 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: email@example.com InTouch is free to TOPRA members. Annual membership of TOPRA is €225. TOPRA members can read or download InTouch online at www.topra.org
Dr Dennis Wong, Project Manager Regulatory Affairs, Alcon Pharmaceuticals, Camberley, UK* Mr Philip Storey, Managing Director, PSF Medical BV, Delft, The Netherlands* Miss Lauren Cook, Regulatory Affairs Associate, PRA International, Reading, UK Mrs Bojana Gacesa, Regulatory Affairs Manager, PRA D.O.O, Belgrade, Serbia Miss Anna Anokhina, Moscow, Russia
Mr Zahir Ahmed, Regulatory Affairs Manager, High Wycombe, UK
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.
Mrs Kathryn Hunter, Regulatory Affairs Associate III, PRA, Reading, UK