K eepin g
y ou
O c to b er 2011
T he T O P R A N ewsletter – K eeping members in T o u ch
Last chance to book for the 2011 Symposium! This year’s Symposium on 13 and 14 October in Rome is once again offering the widest breadth of regulatory focused speakers at any event in the EU. This year we open with a keynote address by Professor Guido Rasi, the current Director General of AIFA, Italy and Executive Director Designate of the European Medicines Agency (EMA) and we have included a special session on the work of the Italian Competent Authorities. Martin Seychell, Deputy Director General DGSANCO, will talk about the work of this Commission DG especially in the regulatory environment. He will also co-chair the panel on pharmacovigilance. This is an excellent opportunity to network with influential industry and agency delegates and to get your knowledge right up to date. Join us for this flagship event in the TOPRA calendar.
Grounds for optimism A message from David Jefferys, TOPRA President This is my first editorial as President of TOPRA. Zubair Hussain will be a hard act to follow. I want to acknowledge his great achievements and Dear colleagues thank him for the great leadership he has provided over the past year. I have had a long association with TOPRA, and thought I knew quite a lot about our organisation. I was wrong; it is only when you join the Board that you finally appreciate the breadth of activities that make up TOPRA. We are fortunate to have such an excellent team led by Lynda to bring all this to fruition, but nothing would happen without people volunteering to run events, give talks, write articles etc. We are blessed to have such support. My thanks goes to all our volunteers. Our exciting programme begins with the Rome Annual Symposium, followed by the EMA meeting and the Awards Ceremony. Early next year we have joint meetings planned with the MHRA, EFPIA, the Commission and with the Institute of Comparative Law. These are challenging times for the life science industry, with major changes taking place in both the process and the structure of drug discovery and development. Market access and health technology evaluation are becoming increasingly important, influencing clinical data requirements and the type of products selected for
development. There are new supply channels and novel approaches to the delivery of product information. Some feel threatened by this turbulence and others question the long-term viability of the industry. In my view there are significant grounds for optimism, especially for regulatory science. We should always remember it is darkest before the dawn. What are the grounds for optimism? A range of new technologies and scientific understanding are opening new treatment options. Much has been set out in a major publication recently released from the FDA, entitled ‘Advancing Regulatory Science in FDA.’ The second major reason for optimism is that a significant number of governments, public institutions and leading figures have recognised that matters cannot go on as they are. There has to be support and reward for innovation and alongside this consideration of major regulatory reform. The life science industry can, and should, be a major driver of economic growth. Health can be an investment and a source of wealth generation, the so-called ‘health and
wealth agenda’. The industry is being seen as a true partner in health and not just a driver of costs. The approach to regulatory science is changing, with key figures realising the importance of regulatory strategy and the pivotal role that the regulatory professional plays. The regulatory function covers every aspect of a product’s development and the regulatory professional is the key link. I look forward to a great year for TOPRA and the profession.
Zubair Hussain – A hard act to follow
K eepin g
y ou
TOPRA Regulatory Affairs Awards 2011 - UPDATE
Congratulations to our shortlist! This year’s Awards have garnered a wealth of high calibre entries from a broad range of Regulatory Affairs professionals and specialist companies. The judging was tough, but only a few can make it onto our shortlist. TOPRA is pleased to announce the following shortlisted candidates:
Horizon l Hayley Hanvey, Pfizer l Shilpa Jain, TRAC Services
Inspiration l
Kathleen Boyce, Janssen, Pharmaceutical Companies of J&J
l
Dr Helen Erwood, Regulatory Resources Group
l
Dr Luis Saturnino Herrera Martínez, Center for Genetic Engineering and Biotechnology (CIGB), Cuba
Education l
Alison Bowers, Consultant, NC, US
l
Ann O’Connor, IMB, Ireland
l
Siegfried Schmitt, PAREXEL
l
Sandra Shire, Arizona State University, US
Communication l
John Deavin, Deavin Associates
l
Stuart Finnie, AstraZeneca
l
Gillian Gauntlett, Molnlycke Health Care
l
Ann O’Connor, IMB, Ireland
Support l
IDIS
l
IDRAC
l
Regulis
l
TRAC Services
All the short-listed candidates can be proud of their achievements and we are delighted to be able to recognise them in this way. We will have to wait until the Awards Ceremony on 24 November to find out who the winners are. Don’t miss out on your opportunity to hear the announcements in person, book your seats at the Awards Dinner by going to www. regulatoryaffairsawards.org, or contact awards@topra.org for more information.
The judging Our prestigious panel of judges includes representatives from regulatory agencies, industry, patients’ associations, legal experts and academia, thus giving a broad range of expertise and varied perspectives on the entries put forward. Of course, the judges can only evaluate the entries they have in front of them, so their decisions must be based on answers provided in the completed entry form and any supporting documentation supplied. Therefore it is essential that nominators answer each of the criteria specified, give examples of how this has been fulfilled and, where appropriate, provide supporting evidence, such as CV, brochure or testimonials, to support the case for that individual, team, company or service. You will notice from the list of shortlisted categories, one is missing. This year, on the judges’ advice, it was decided to withhold the Award for Innovation as the information supplied in the entries did not
provide sufficient evidence to justify an Award for Excellence in this category. TOPRA is committed to recognising Innovation within the Regulatory Affairs sector and it is important that any shortlisted nominations or winners in this category – and any other – are truly worthy of receiving the accolade of a TOPRA Regulatory Affairs Award. This view is shared by Samarind RMS, who have been associated with this category since they were the first winners last year and committed to sponsoring the category earlier this year. TOPRA would like to thank Samarind for their commitment to this Award and their ongoing commitment to the TOPRA Regulatory Awards Programme as a whole. The Innovation Award will be open for entries again next year, and the TOPRA Awards committee will pay particular attention to reviewing the requirements and support to potential candidates before entries are invited next Spring.
ife Time L Achievement Award As last year, our Life Time Achievement Award attracted nominations on behalf of several ‘superstars’ of the healthcare regulatory world. The winner will be announced at the Awards Ceremony and we are delighted to announce that Samarind RMS will be handing the LTA trophy to the worthy winner at the ceremony. Miranda Pothiawala, Samarind’s
Software Director commented, ‘We are delighted to be in a position to continue our support of the TOPRA Regulatory Affairs Awards and we look forward to presenting the winner of the Lifetime Achievement Award with their trophy in London on 24 November.’
Sponsorship We’d like to thank Thomson Reuters, supporting Inspiration; NDA Group, as Regulatory Affairs Awards Champion; and our Media Sponsor Ash for their continued support of the Awards. Your company can still support these prestigious awards – either as a Category Sponsor or as a Regulatory Affairs Award Champion, contact mark.wilkins@ ashridgecommunications.com for more information.
The event Why not congratulate the short-listed candidates in person and mingle with many leading industry and regulatory agency figures of the Regulatory Affairs at the TOPRA Regulatory Affairs Awards Ceremony on 24 November 2011. The event coincides with the Joint TOPRA/ EMA Annual Review meeting in London. To book your place at the Awards dinner, which will be held at the Four Seasons Hotel in Canary Wharf, go to www. regulatoryaffairsawards.org for a booking form or email awards@ topra.org.
T he TOPR A N ewsletter – K eeping members in To uch
O c to be r 2011
NEW BOARD ANNOUNCED FOR 2011-12 David Jefferys
At the Annual Meeting for 2011 held at the TOPRA offices on Thursday 8 September, the new Board for the next session was revealed. There had been a tightly-fought election for the role of President-Elect between two excellent candidates: Patrizia Nestby and Carlos Langezaal. Both candidates have been very active in TOPRA for a number of years and received significant support in the on-line voting. In the end the winning candidate was Patrizia Nestby and we congratulate her on her success. Four candidates were nominated for four vacant Director posts and so all were elected unopposed.
The Board for the 2011-12 session will be: PRESIDENT
David Jefferys
UK
PAST PRESIDENT
Zubair Hussain
UK
PRESIDENT-ELECT
Patrizia Nestby
The Netherlands
NORTH AMERICA REPRESENTATIVE
Monique Garrett
US
EUROPE REPRESENTATIVE
Aine Kane
UK
DIRECTORS
Steve Brookes Niamh Lawler-Turner Sarah Roberts Jonathan Trethowan
UK
Zubair Hussain
Patrizia Nestby
Monique Garrett
Aine Kane
Ireland UK UK
The following Board members have retired having served their term of office: Margareth Jorvid, Angela Miller and Paolo Biffignandi. The President paid tribute to them at the Annual Meeting, thanking them for their long service and many achievements. He noted that they will all continue to be very active in TOPRA in various capacities, including the forthcoming Symposium, publications, local ‘TOPRA In…’ groups and future educational meetings – so their skills and experience will continue to be put to excellent use!
TOPRA ANNUAL MEETING 2011 Steve Brookes
Niamh Lawler-Turner
The Annual Meeting also heard a report of the activities of the past year in which TOPRA, using its volunteers and staff team, has continued to deliver a programme of high-quality education and training and an excellent journal. The organisation has had continuing engagement with key ‘stakeholders’, including many national agencies, EMA, the EU Commission, patient and HTA groups and other professional bodies. This year has
seen the development of regional ‘TOPRA In…’ groups in a number of countries and further development of contacts with students and universities. There has been increasing careers support with the new Careers book, an enhanced Job Shop service, career coaching with ‘Four Pillars’ and the set up of an intern introduction site on the web. We have conducted a programme of member calls and member research including face-to-face meetings with key individuals from major companies. Work on internal governance has continued including the development of a Statement of Values, an updated organisation chart and new internal Awards. Of course a major highlight of the year was the first TOPRA Awards for Regulatory Excellence event held in London. Overall a very busy year! The meeting also reviewed the financial position for the accounting year 2010, which showed that despite the economic difficulties TOPRA reported a small profit. The good performance of our carefullymanaged investment portfolio assisted with this. The President noted that conditions in 2011 were even more challenging and that the organisation was being very careful to manage costs and focus its activities to continue to husband our financial resources. A number of awards were announced. Honorary Life Members have been appointed and will be presented with their certificates at suitable future public events – see later in this edition for more details on these new appointments. The President’s Award for the Board member of the year was given to Paolo Biffignandi and the TOP Team for 2010 was named as the 2010 Annual Symposium Working party, chaired by Alan Hunter. Closing the meeting, the new President, David Jefferys, thanked all for their hard work in the past year, in particular Zubair Hussain in his role as President in that time. He reviewed his vision for the coming 12 months and looked forward with optimism to a year of further success! Copies of the Annual Meeting presentation and the annual audited accounts for the year will be available on the website for members to review. If you have any questions, please do e-mail Lynda@topra.org.
The 8th TOPRA Annual Symposium 2011 Date: 13–14 October 2011 Venue: Crowne Plaza Hotel, Rome, Italy Sarah Roberts
A u g u st 2 0 0 9 Jonathan Trethowan
K eepin g
y ou
O c to ber 2011
Honorary Life Membership of TOPRA This honour has recently been accepted by senior figures from the world of veterinary and medical device regulation. These are: Susanne Ludgate (MHRA) Steve Dean (VMD) Peter Jones (latterly from EMA) In addition, John Purves – our first Lifetime Achievement Award winner – has also been given Honorary Life Membership. TOPRA is delighted to add these to the panel of very eminent regulatory professionals and those who have worked in the broader area of healthcare regulation who are TOPRA Honorary Life Members. They are drawn from agencies, academia, companies and government and greatly enrich the TOPRA membership. They are invited to special events and a number of our Honorary Life Members serve on TOPRA committees. Originally only those who have not been members before could be invited, but in recent times the honour has been extended to original founder members and others who had been active within TOPRA. Because of this change the rules applied have been adapted to allow those who had been awarded Fellowship in the past to continue to use FTOPRA if they wish, although they would relinquish the right to be a full voting member once they have accepted Honorary Life membership. The Board has also accepted a proposal from the STAR panel that those who have served TOPRA as President of the organisation should be considered for Honorary Life membership when their period of service on the Board has ended. The award of Honorary Life Membership would not be automatic
and cannot apply to those who choose to continue to serve on the Board in another capacity. Those ex-Presidents who wish to continue as voting members can defer acceptance of their Honorary Life Membership, once offered, until such time as they wish to step down from these activities. Being President of TOPRA is a significant responsibility, requiring commitment of time and energy and being a figurehead for the organisation, and meeting many of the criteria on which such honours are assessed. We are very fortunate that each of our Past Presidents has given great service to TOPRA and as a result made a significant contribution to the development of our profession. Thus Honorary Life Memberships have recently been offered and accepted by Brian James, Cheryl Hall, Margareth Jorvid and Alan Hunter. Craig McCarthy and Paolo Biffignandi have also accepted but will defer taking up this honour to a later date.
Paolo Biffignandi won the President’s Award for TOPRA Board member of the year. Executive Director Lynda Wight makes the presentation.
Miss Gazala Ahmed Mrs Hannah Crown Miss Natalie TEVA UK Ltd, Harlow, UK Janssen Pharma, High Hopkins Warlingham, UK Dr Sarah Bentouati Wycombe, UK*
Dr Daniel Bollag ARIAD Pharmaceuticals Inc, Cambridge, US
Miss Caroline Goodall Pharmalink Consulting Ltd, Maidenhead, UK
Mrs Nada Harding Mrs Dorothy Bruce Genzyme Norgine, Uxbridge, UK* Therapeutics Ltd, Oxford, UK* Mr Graham Burton Celgene Corporation, Mr Donal Hempenstall Summit, US* Real Regulatory Ltd, Dr Alain Chatelin London, UK Altius Pharma CS, Mrs Hayley Paris, France Henworth Mundipharma Research Ltd, Cambridge, UK*
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.
TOPRA
TOPRA welcomes the following new members who joined recently. A full list of new members can be found at www.topra.org/intouch.
RB Pharmaceuticals Ltd, Slough, UK
Michael Bangs, Greer Deal and Virginia Guellal
© 2010 The Organisation for Professionals in Regulatory Affairs
NEWTOPRAMEMBERS F Hoffmann La Roche, Mr Malcolm Doak Basel, Switzerland Co. Wicklow, Ireland (Student Member) Mr Indie Bidiyal
InTouch Editors:
Dr Tushar Kokate Oakland, US
Miss Bindu Patel Sanofi Pasteur MSD, Maidenhead, UK* Ms Kerstin Persson Crucell Sweden AB, Stockholm, Sweden
Mrs Kirsten Lentz Danish Medicines Mr Christian Agency, Copenhagen, Petrovic Denmark Broxbourne, UK (Student Member) Mr Michael
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
Ms Jacqueline Shaughnessy Sanofi Pasteur MSD Ltd, Maidenhead, UK* Mrs Suad SheikhHassan Southall, UK Mr Ioannis Steliou Ministry of Health, Nicosia, Cyprus
Loveridge Parexel International, Uxbridge, UK
Mr Greg Plunkett Plunkett Consulting Pty Ltd, Australia
Mr Klaus Tressl Linde Healthcare AG, Pullach, Germany*
Miss Rachel Macdonald Norgine Ltd, Uxbridge, UK
Mr Daniel Rana Stryker UK, Newbury, UK
Miss Andrea Tymichova London, UK
Ms Karen Schuldt Ms Michaela Nahler Medimmune Ltd, Basel, Switzerland Cambridge, UK (Student Member) Mrs Karen Seath Dr Bonnie Okeke Anstruther, UK* GOJO IndustriesEurope Ltd, Milton Keynes, UK
Bellerive House 3 Muirfield Crescent London E14 9SZ
Dr Nicola Whitaker Sarrians, France
*Registered Member
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