K e e p i n g
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O c tob er 2012
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 Now that the Olympic Games are over, and the days are shorter, we may think there is nothing much to look forward to. Well, there is! There is the TOPRA Awards Ceremony on 28 November. See who is on the shortlist and how to book your place at this prestigious event (page 2). And, if you want to be part of it as a sponsor, there is a still time to sign up. As David Jefferys says, one of the benefits of being a TOPRA member is to be part of our community. You can find out how to participate in TOPRA activities in the boxed story (opposite). There are plenty of opportunities to contribute to TOPRA and you do not need to invest too much of your time. Another benefit of membership is the sharing of information and education, eg, the successful webinar reported on by Monique Garrett and the new booklet on Regulatory Intelligence that has just come out (see page 3). Virginia Guellal, Co-editor
Making benefit-risk decisions A message from David Jefferys, TOPRA President Benefit–risk evaluation and communication is arguably one of the hottest topics in medicines regulation. It is a subject which has featured Dear colleagues extensively in TOPRA meetings over the past few months There was considerable debate on benefit–risk at the joint meeting with the European Commission on the new pharmacovigilance legislation held in Brussels on 28 June. Benefit–risk was also the subject of our first Roundtable discussion held at the Royal Society on 13 September. This meeting featured a debate around the implications for the industry and for the courts and the legal profession. Previously, courts have had to consider risks, whereas now they will have to make a decision around the integration of benefit and risk. Writing this editorial ahead of that meeting and our Annual Symposium, I am confident that we will have a great debate at the Roundtable and also that we will further consider the implications of benefit–risk during the Annual Symposium in Dublin. In one sense, benefit–risk is not a new topic, and it can be argued as having been at the centre of medicines regulation since Directive 65/65 and the 1968 Medicines Act in the UK. However, until the recent pharmacovigilance legislation, benefit–risk has not been enshrined in law. Neither has it been a requirement for there to be a clear audit trail establishing how benefits and risks are considered and balanced in the decision process. All this has changed. The implications of this change will be felt well beyond
pharmacovigilance and well beyond the European region. Through the work of Professor Larry Phillips, Emeritus Professor of Decisions at the London School of Economics, we have a range of new tools including quantitative assessment and the use of decision conferencing. As Regulatory Affairs professionals, risk communication and risk evaluation are fundamental to our work. Increasingly other groups will need to be included in the debate about the acceptable level of risk and how this is to be balanced. TOPRA is in a good position to contribute and influence this debate. In the past there was a rather paternalistic approach in that the healthcare professional
and the regulator knew best, but this is changing and patients and the wider public are becoming part of the discussion. This must be correct, and we have to ask whose risk is being considered and whose benefit? The answer is of course the patient, which means that more information must be available so that informed patients can come to their own decisions. One of the benefits of being a TOPRA member is that you can be part of these important discussions. The risk of not being a TOPRA member is that you will not be up-to-date in this crucial area and be outside of the discussions. So one of the easiest benefit–risk decisions of all is to become and stay a TOPRA member!
A warm thank you
to our volunteers!
Without your drive and input TOPRA would not be the dynamic and engaging organisation it is today. We depend on TOPRA members to come up with ideas and participate in all our member and education services. We get many requests from members who want to volunteer but are not sure what it involves, what will be expected of them or what support they will receive from other volunteers or the office team. Hopefully the answers to most, if not all, of these questions will be found in a Guidelines for volunteers document, which you can request from the office at volunteering@topra.org or download from our volunteer page on the website – www.topra.org/volunteering. If you would like to volunteer or have any additional questions about participating in TOPRA activities, please email Lynda@topra.org.
Awards K e e p i n g
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Awards Update 2012 Congratulations to our shortlist
The wait is over. The judges have finished their deliberations, the scores have been collated and shortlists have been compiled. This year we had a pleasing number of entries in every category which, almost without exception, were highly detailed nominations. The judges had to make some tough choices, but the shortlisting process is complete. We’d like to congratulate everyone who appears on it and look forward to celebrating their achievements at the Awards Ceremony on 28 November at the Radisson Blu Portman in London. We are delighted to announce the shortlisted nominees for this year’s TOPRA Regulatory Affairs Awards:
COMMUNICATION Hilde Boone (EMA) and Janice Soreth (FDA) Jonathan Trethowan (TRAC Services) Kim Wharton (Regulis Consulting)
HORIZON
Jenny Gray (Regulis Consulting) Sheetal Mudda (MicroLabs) Eileen Ryan (Acorn Regulatory Consultancy Services)
INNOVATION
Alan Colley and Alex Yates (Amgen) Mike May (TRAC Services) Gerald Thompson (Boots)
INSPIRATION
Gemma Robinson (Acorn Regulatory Consultancy Services) Joanna Schmidt (Abbott) Henrietta Ukwu (PPD)
EDUCATION
Sue Harris (MHRA) Frances Richmond (University of Southern California) Nancy Smerkanich (Octagon Research Solutions)
SUPPORT
EMA’s SME Office (Melanie Carr) Regulis Consulting (Amy Whyte) Samarind (Miranda Pothiawala)
LIFE TIME ACHIEVEMENT
his special category recognises an individual who has demonstrated a T significant and lasting contribution to Regulatory Affairs. Unfortunately, we can only recognise one individual so, as in previous years, we do not reveal who was on the shortlist. The winner will be announced at the Awards Ceremony on 28 November.
Attend the Ceremony and the Annual Lecture
Join us at the Awards Ceremony and take the opportunity to attend the inaugural TOPRA Annual Lecture. Sir Michael Rawlins will take a controversial and thought-provoking look at Regulatory Affairs. Sir Michael was Chairman of the National Institute for Health & Clinical Excellence (NICE) from its formation in 1999. He has been a Vice-Chairman and Chairman of the Committee on Safety of Medicines, at the UK Regulatory Agency. His experience as a physician and as a regulator gives him a unique perspective on how Regulatory Affairs contributes to patient wellbeing and whether current regulatory systems deliver the right medicines, in the right time frame for the right price. Find out why he believes understanding the Centralised Procedure is no longer enough for RA professionals. But what will be the key skills for a regulatory scientist in the future? Come and hear Sir Michael’s forthright opinions on how the regulatory profession should be developing.
Book your place now!
Book your seats at the Lecture, Dinner and Ceremony at www.topra.org/awards-2012-bf. Special rates for table sales and parties of attendees, contact awards@topra.org for more information.
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 the 2012 TOPRA Awards, please contact Mark Wilkins, by email mark.wilkins@ashridgecommunications.com or telephone: +44 (0)1753 714999.
Thank you to our sponsors
RMS samarind pharmaceutical software solutions
The first TOPRA Roundtable meeting was held on 13 September in the prestigious surroundings of the Royal Society in London. The concept behind these Roundtable meetings is to provide a forum for invited senior regulatory professionals to debate some of the most pressing and, perhaps, controversial topics in a confidential environment, seeking to identify the key issues and possible ways forward. The first meeting was on the topic of benefit–risk and examined the disconnect between consumer protection and regulatory legislation. The meeting was attended by legal specialists and regulatory professionals. Alan Hunter, Chairman of the TOPRA STAR panel and ex-President set the scene and the ground rules for the evening. Presentations were made by David Jefferys (TOPRA President and Executive Vice President of Eisai) and Alison McAdams, Partner at the legal firm DAC Beachcroft LLP. The debate was then opened to the audience. At the end Peter Feldschreiber (MHRA and 4 New Square) summarised the main conclusions and the delegates adjourned to continue their discussions over dinner. A summary of the main conclusions will be issued by TOPRA in the near future and attendees will be able to visit a closed area of the TOPRA website to view the presentations, supporting materials and the summary statement. If you would like to be on the list for invitations to future meetings please contact Lynda@topra.org.
A year in the life... of TOPRA Our Annual Review of the Board year October 2011 to September 2012 was published in time for the Annual Review meeting at the Symposium. The TOPRA Annual Review covers all the highlights of our activities, especially new developments, over the past year. Find out what TOPRA has achieved in terms of meetings – the Rome Symposium was the most successful so far – and extending membership throughout Europe – via a healthy number of new TOPRA In groups. Another important development to note was the launch of our Statement of Values. Last but not least, the report includes our financial statement for the year. If you were unable to attend the meeting, you can obtain a print copy by contacting Lynda@topra.org with your postal address or download a pdf of the report at www. topra.org/annual-review-2012. There are a limited number of print copies so they will be distributed on a first come first served basis.
T h e TOPR A N e wsle tt er – K eepin g memb e r s in To uc h
Innovative webinar series We often talk about the importance of understanding how the international regulatory landscape is changing as the profession continues to evolve toward a more global approach to product development and market approval. This has created an ongoing need for education about region-specific regulatory processes, so TOPRA North America Leadership Team (NALT) has been working on an Innovative Webinar series. On 11 and 12 September, TOPRA launched a unique collaboration with Extension Services in Pharmacy at the University of Wisconsin in Madison by conducting a two-part webinar series entitled, An Overview of US and European Regulatory Processes for Drugs. Extension Services in Pharmacy at the University of Wisconsin provided the technology platform, registration tracking and logistical support while the TOPRA NALT coordinated the presenters and content. The series was very well attended by academic and industry professionals alike. ‘An Overview of US Regulatory Processes for Drugs’ was presented by Nancy Smerkanich, Vice President of Regulatory Affairs Consulting at Octagon Research Solutions, Inc. Patricia Anderson, Vice President of Regulatory Services, SRS at OptumInsight, Inc, then presented ‘An Overview of European Regulatory Processes for Drugs’. Both presentations introduced relevant legislation followed by investigational and marketing authorisation procedures. Both also highlighted the unique characteristics and requirements of the region being discussed. The attendance rates and lively discussions that followed these presentations illustrated a high level of interest in the topic and suggested the need for more similarly structured (web-based) programs. This joint project with Extension Services in Pharmacy at University of Wisconsin enabled both organisations to provide a cost-effective educational opportunity to an incredibly diverse audience that included students, life sciences professionals and regulatory teams who logged in from around the world to participate in the webinar series. We look forward to future collaborations that support the educational needs of regulatory professionals around the world. Monique Garrett, NALT
HOT OFF THE PRESS!
TOPRA is proud to announce the publication of The TOPRA Guide to Regulatory Intelligence which describes the basic principles, aims and methodologies relating to Regulatory Intelligence for newcomers to this key specialism in Regulatory Affairs. It discusses the RI environment; where to find and exploit some of the myriad RI information sources available; how RI relates to other forms of intelligence; its value, both within RA departments and at a wider corporate level, and how individuals and organisations can employ RI to support their products through the regulatory submission process and throughout a product’s lifecycle. This 96-page booklet is available for £40 on Amazon or at www.topra.org/ribookletbf.
O c to b e r 2012
News From the Board... Our occasional column keeping you up to date with the discussions at the TOPRA Board meetings continues with this report from the September 2012 meeting ● The Board heard about the positive response to
the set up of the TOPRA Consultation Group. This Group will look at relevant Consultations and respond to them for TOPRA from the point of view of the regulatory profession. ● Monique Garrett, the North America
representative (joining by phone at an incredibly early hour) reported on the very successful webinars that TOPRA had held in conjunction with the University of Wisconsin (see left for article). ● The July management accounts were reviewed
which showed low revenues (as is the case in the summer months when events are few) but better than budget figures for the year to date. ● Three policies developed by the Finance
Committee were discussed and two agreed, while more work will be done on the third. ● The Board agreed to pilot the continuous credit
card payment option at the 2013 renewal for those paying in sterling or Euros. ● The TOPRA social media policy was tabled and
agreed. This will be made available on the website for all members to read very shortly. Watch out for tweets from the 2012 Dublin Symposium! ● TOPRA has been discussing collaborations with
RAPS (USA), RegNed (in the Netherlands) and a group based in Israel and the Board agreed that these discussions should continue. ● Updates were given on progress with TOPRA MSc
changes and it was noted that all was proceeding well. ● The Board also prepared for the 2012 Annual
meeting that will be held in Dublin. ● Following the regular Board session, the Board and
some staff members joined in a special meeting to discuss the future strategy for TOPRA. Good progress was made and the discussions will continue at the next meeting in November.
w w w. t o p ra . o r g / i n t o u c h
K e e p i n g
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O c to ber 2012
Lindsey joins veterinary consultancy TOPRA member Dr Lindsey Toon (pictured) has just joined TSGE, a European regulatory consultancy, which is expanding its Veterinary Vaccines and Biologicals expertise. Lindsey has a broad experience in veterinary vaccine development and registration, gained with key players in the sector. She holds a PhD in Microbiology from the University of Leeds. Since then, Lindsey has been involved in the research, development and registration of veterinary vaccines, and she brings specialist skills including product development, regulatory strategy for conventional and novel vaccines, all regulatory aspects for the use of veterinary vaccines and biologicals in the EU and the rest of the world and a sound knowledge of the production environment and technical assay development. With proven negotiating skills with the EMA and national regulatory authorities, Lindsey can provide strategic advice and practical support on veterinary vaccine development and regulatory needs.
TOPRA Staff
Who’sWho A series in which InTouch profiles members of TOPRA’s office team
Lisa Gordon – Membership and Publishing Coordinator Lisa celebrates her tenth year of working for TOPRA this month. She joined BIRA in the 1990s as Office Services Assistant. In early 2000 she travelled to St Lucia for an extended working holiday, rejoining TOPRA in 2002 as Academic Administrator for the MSc. She held this role until 2004 until the birth of her first child. Returning from maternity leave, Lisa then took on the role of Membership Coordinator – which she now combines with advertising and publishing support. Lisa handles all member inquiries, applications, renewals and maintains records. Part of her role is to provide regular membership statistics and database analysis. She also acts as a point of contact with the SPINs and student members. Lisa also provides advertising and subscription sales support, such as processing new Job Shop orders and service directory entries. You can contact her at Lisa@topra.org.
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently
Ms Sarah Thorn, KoRa Healthcare, Dublin, Ireland* Dr Didier Relin, OM Pharma/Vifor Pharma, Geneva, Switzerland* Ms Elizabeth Okoria, Uxbridge, UK* Mrs Rosella Taylor, Gilead Sciences International, Cambridge, UK* Mr Virajsinh Gohil, MHRA, London, UK Dr Todd Parorello, F Hoffman La Roche, Nutley, NJ, US* Dr Lindsey Toon, Aylesbury, Buckinghamshire, UK*
Dr Jean-Cassien de Foucauld, Ceva Sante Animale, Libourne, UK* Mr Derek Moriarty, GlaxoSmithKline, Rathfarnham, Dublin, Ireland Dr Mary Celine Scott, Trius Therapeutics, CA, US* Dr Faraneh Attarchi, Abbott Laboratories, Abbott Park, US* Dre Mereth BrevikAndersen, Pronova Biopharm, Lysaker, Norway* Dr Joyce Kroot, Elshout, The Netherlands*
Mr Jan Dingemans, QDossier, Wallwijk, The Netherlands* Dr Beate Lohr, Klifovet, Munich, Germany* Mr Scott Milliken, Glasgow, UK [Student] Dr Kimberly Simmons, Novartis Animal Health UK, Camberley, Surrey, UK* Dr Greg Hooper, Roche Products, Welwyn Garden City, Hertfordshire, UK* Miss Kelly Munnery, Gilead Sciences International, Cambridge, UK
Mr Jamil Chowhan, Bio-Standards, Olaya District, Riyadh, Saudi Arabia* Dr Paul Strijbos, Oxford Pharma Genesis, Basel, Switzerland* Mr Saleh Bessissow, Quebec, Canada [Student] Miss Viola Bennert, Frankfurt, Germany* Ms Roma McSharry, Novartis, Dublin, Ireland Dr Violeta Marmon, Bio-T Consulting, Abingdon, Oxfordshire, UK* Mrs Helen Sharp, High Wycombe, Buckinghamshire, UK*
Ms Tian Yang, Coralville, USA [Student] Dr Matthias Jauslin, Novartis Pharma, Basel, Switzerland* Mr Daniele Sartori, Lombardia, Italy Ms Francesca Edelmann, Potters Bar, Hertfordshire, UK Dr Clare Carmel, Liverpool, UK* Ms Joan Smyth, Raheny, Dublin, Ireland [Student]
*Registered Member
InTouch Editors: Jenine Willis, 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 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
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.
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