KEEPING YOU THE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCH FEBRUARY 2012 Highlights of this issue The 2012 Regulatory Affairs Awards are on their way! Would you like to be an ambassador for the Awards? We are looking for proud RA professionals to encourage their colleagues to recognise excellence through nominations to these prestigious Awards. For more information contact [email protected], see page 2. Would you like to be a TOPRA Fellow? The process for recognising senior RA members in this way has changed, see page 3. Don’t forget to send us your news, pictures, etc. We want you to share your happy moments and achievements with us – and the TOPRA membership. By the way, congratulations to Angela and Nick, see back page. Virginia Guellal, Co-editor, InTouch As a result I have read or, in one case re-read, three very interesting books which I thought I would bring to your attention. The first was recommended to me by Sir Michael Rawlins and is entitled The Theory that Would not Die written by Sharon Bertsch McGrayne. This book describes the complex history of the Bayesian Rule or, as we now know it, Bayesian theory. It describes how the theory was developed and put forward in the 1740s and was taken up by the great philosopher scientist, Laplace, in France. There is a fascinating account of how the theory waxed and waned, engendering sometimes bitter controversy between the frequentists schooled by Skinner and the probabilistic, or perhaps better described, probability density, statisticians. The book relates how the theory was used by actuaries in the early 20th century and then came to play a dominant role during the Second World War by helping break the Enigma Code at Bletchley Park. The book goes on to show how the full impact of Bayesian statistics may not have come to light because of some of the sensitivities during the Cold War period. There are some very interesting discussions on its applications in clinical research. It also looks to the future and the increasing importance of Bayesian theory and probability density statistics in determining social policy and in the evaluation of healthcare products and their utility. The author describes how Bayes’ theory was rediscovered and reinvigorated by Savage who forced pupils to think about combining the concepts of utility with the quantification of uncertainty. The recurring theme of the book is how the theory keeps being rediscovered to address new issues. It could be seen as a good example of evolutionary process. Another book I want to highlight is The Future of Pharma by Professor Brian Smith. He suggests how the pharmaceutical industry may evolve and considers how companies will have to adapt to survive in a rapidly changing environment, approaching the subject from the perspective of evolutionary economics. According to Smith, there is A good read - and some lessons A message from David Jefferys, TOPRA President I have recently been involved in two working parties: the first looking at the future of the pharmaceutical life science industry; the second considering market access issues for emerging/developing countries. no difference between the complex organisations of big pharmaceutical companies and complex living systems. This compelling book describes the all too familiar situation we are facing in the healthcare industry. He sets out the large challenges, but remains optimistic suggesting how the successful will reinvent themselves and will bring forth new benefits for patients - and for the economies. Finally is the book I re-read, Turning the World Upside Down, by Nigel Crisp, the former Permanent Secretary and Chief Executive of the NHS. He explores what richer countries can learn from poorer ones and suggests that we should think in terms of co-development, with each party learning from the other. He sets out a vision of global health based on our interdependence. All three books are well worth reading and set out broader themes which the wider Regulatory Affairs profession is going to have to grapple with over the next decade and beyond. Centre of Excellence in RA STOP PRESS: The COGENT National Skills Academy has accredited TOPRA as the UK’s ‘Centre of Excellence in Regulatory Affairs’. Cogent is the UK’s industry skills body for chemicals, pharmaceuticals, and other businesses. It is an employer-led government-funded Sector Skills Council (SSC) working with industry to research and forecast skills needs and develop fit-for- purpose standards and qualifications within particular sectors. For more information, email [email protected]or look for details in next month’s InTouch
Transcript
K e e p i n g y o u
T H E T O P R A N E W S L E T T E R – K E E P I N G M E M B E R S I N T O U C H February 2012
Highlights of this issueThe 2012 Regulatory Affairs Awards are on their way! Would you like to be an ambassador for the Awards? We are looking for proud RA professionals to encourage their colleagues to recognise excellence through nominations to these prestigious Awards. For more information contact [email protected], see page 2.
Would you like to be a TOPRA Fellow? The process for recognising senior RA members in this way has changed, see page 3.
Don’t forget to send us your news, pictures, etc. We want you to share your happy moments and achievements with us – and the TOPRA membership. By the way, congratulations to Angela and Nick, see back page.
Virginia Guellal, Co-editor, InTouch
As a result I have read or, in one case re-read, three very interesting books which I thought I would bring to your attention.
The first was recommended to me by Sir Michael Rawlins and is entitled The Theory that Would not Die written by Sharon Bertsch McGrayne. This book describes the complex history of the Bayesian Rule or, as we now know it, Bayesian theory. It describes how the theory was developed and put forward in the 1740s and was taken up by the great philosopher scientist, Laplace, in France.
There is a fascinating account of how the theory waxed and waned, engendering sometimes bitter controversy between the frequentists schooled by Skinner and the probabilistic, or perhaps better described, probability density, statisticians. The book relates how the theory was used by actuaries in the early 20th century and then came to play a dominant role during the Second World War by helping break the Enigma Code at Bletchley Park. The book goes on to show how the full impact of Bayesian statistics may not have come to light because of some of the sensitivities during the Cold War period.
There are some very interesting discussions on its applications in clinical research. It also looks to the future and the increasing importance of Bayesian theory and probability density statistics in determining social policy and in the evaluation of healthcare products and their utility.
The author describes how Bayes’ theory was rediscovered and reinvigorated by Savage who forced pupils to think about combining the concepts of utility with the quantification of uncertainty. The recurring theme of the book is how the theory keeps being rediscovered to address new issues. It could be seen as a good example of evolutionary process.
Another book I want to highlight is The Future of pharma by Professor Brian Smith. He suggests how the pharmaceutical industry may evolve and considers how companies will have to adapt to survive in a rapidly changing environment, approaching the subject from the perspective of evolutionary economics. According to Smith, there is
A good read - and some lessonsA message from David Jefferys, TopRA president
I have recently been involved in two working parties: the first looking at the future of the pharmaceutical life science industry; the second considering market access issues for emerging/developing countries.
no difference between the complex organisations of big pharmaceutical companies and complex living systems.
This compelling book describes the all too familiar situation we are facing in the healthcare industry. He sets out the large challenges, but remains optimistic suggesting how the successful will reinvent themselves and will bring forth new benefits for patients - and for the economies.
Finally is the book I re-read, Turning the World upside Down, by Nigel Crisp, the former Permanent Secretary and Chief Executive of the NHS. He explores what richer countries can learn from poorer ones and suggests that we should think in terms of co-development, with each party learning from the other. He sets out a vision of global health based on our interdependence.
All three books are well worth reading and set out broader themes which the wider Regulatory Affairs profession is going to have to grapple with over the next decade and beyond.
Centre of excellence in raSTOP PRESS: The COGENT National Skills Academy has accredited TOPRA as the UK’s ‘Centre of Excellence in Regulatory Affairs’.
Cogent is the UK’s industry skills body for chemicals, pharmaceuticals, and other businesses. It is an employer-led government-funded Sector Skills Council (SSC) working with industry to research and forecast skills needs and develop fit-for-purpose standards and qualifications within particular sectors.
For more information, email [email protected] or look for details in next month’s InTouch
K e e p i n g y o u
Start thinking about your entries now! We need your help to identify those people, teams and organisations you consider to be heroes in the world of Regulatory Affairs. So how can you ensure that your colleagues receive the recognition they deserve for the excellent work they are doing for patients and the profession?Simple – enter your colleagues or team for the TOPRA Regulatory Affairs Awards.
There are seven categories so you will definitely find an Award to match your regulatory ‘Star’:
TOPra has been gratified by the level of support for the awards from the industry. This year we are pleased to welcome back Samarind and Thomson reuters as category sponsors.
We are now making plans for this year’s TOPRA Awards event. It will be held in late November at a venue in London. As the plans are firmed up we will keep you posted. Don’t forget to keep checking our website – www.regulatoryaffairsawards.org – for updates and information on when and how to enter.
TOPra awards update 2012Planning is well underway for this year’s awards
samarindRMSSamarind will be sponsoring this year’s Innovation Award. Software developer at Samarind, Miranda Pothiawala, says ‘We have seen measurable benefit from our association with TOPRA over the past few years... As a result of the many benefits our association with TOPRA brings, we are proud to continue our support of the Regulatory Awards in 2012, through our sponsorship of the Innovation category.’
Many companies have expressed an interest in being aligned with these prestigious awards, so we are inviting potential sponsors to secure first reserve on sponsorship opportunities that would nicely complement existing company promotion and marketing plans.
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 [email protected] or telephone: +44 (0)1753 714999.
★ eDuCaTION: This Award recognises individuals or organisations who have made a significant contribution to the world of regulatory education and professional development
★ COMMuNICaTION: This Award recognises RA professionals who have promoted the safe use of medicines by communicating complex healthcare messages in a way that is transparent and brings about positive changes in practice
★ INSPIraTION: This Award recognises exceptional contributions by an individual in inspiring fellow regulatory professionals in the development of their regulatory career, or as an inspirational team leader.
★ HOrIZON: This Award recognises an outstanding ability in an individual who is starting out on their regulatory career – they will have already shown leadership skills, motivation and commitment to regulatory affairs
★ SuPPOrT: This award recognises the critical role that supporting organisations play in the drug development process and the full life cycle of the drug
★ INNOVaTION: This Award recognises that innovation is a key differentiator; it is a measure of the regulatory profession’s ability to adjust to the healthcare market and patient needs
★ aCHIeVeMeNT: This Award recognises an individual who, throughout their career, has gone that extra mile and demonstrated a significant and lasting contribution to their work and/or the development of Regulatory Affairs as a profession.
For more information on entering, the categories, judging criteria and deadlines go to: www.regulatoryaffairsawards.orgor email: [email protected]
Supporting the Awards
THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH
AWARDS TIMELINESRegister your interest in entering the Awards – NOW!
• Entries open – Monday 12 March
• Closing date – Friday 22 June
• Shortlist announced – mid-September
• Awards ceremony – 28 November [TBC]
The TOPRA Regulatory Affairs Awards 2012 will be held at a venue in London, UK.
A U G U S T 2 0 0 9
New developments in Fellowship nominationsLike many similar organisations, TOPRA uses the award of ‘Fellowship’ to designate those members who have made a mark on their profession and have really made a contribution over and above just doing their job well. Fellows of TOPRA can use FTOPRA after their name to signify the standing that they have in the regulatory community and are invited to special events just for them. It is an honour to be awarded Fellowship and something that all members should aspire to!
Fellowship is open to members of TOPRA who have:
• A minimum of 10 years’ experience in Regulatory Affairs
• Hold a position of professional responsibility
• Have contributed notably to the advancement and development of the RA profession.
Nominations for Fellowship are reviewed in confidence by the Fellowship Appointment panel, comprising a number of existing Fellows, who consider all the information about the applicant and then recommend to the Board whether a Fellowship should be awarded or not. The nomination includes all information about the nominee’s career history, but more importantly explains what the nominee has done to support or further Regulatory Affairs. This may be work they have done for TOPRA as a volunteer, but could equally be service on other committees (eg, in trade bodies) or teaching and lecturing activity. It could be mentoring or helping to shape new legislation: anything that goes beyond simply doing what’s expected of them in their employment.
Currently, applications can only be made by colleagues who should not tell the nominee that they are putting forward their name – and this system will continue as one option. But it is easy to see that putting forward the best case for a nominee can be hard if you can’t ask them for full details of their CV and all that they have achieved! So in order to make the process more straightforward and transparent, and improve the quality of the nominations made, the Board has agreed to allow members to submit their own nominations.
The proposal will still have to be counter-signed by two members (one a Fellow) to ensure that the information given is true, and it will be up to the member to approach individuals who already know them. The proposal will still be considered against the strict criteria and will still be passed to the Board for ratification, so control mechanisms and rigorous review will still be in place.
Members may still be turned down if their application or experience is insufficient or not well documented enough. Of course, it will be disappointing for a member to learn their application has been rejected but this does happen in many other professional bodies. Such applicants will be made aware of the reason for a negative decision, but of course this will give them an opportunity to address any shortcomings in their application and re-apply.
The Board hopes that this development in the application process will encourage more of you to think about putting yourself forward for Fellowship and gaining the recognition from your peers that you deserve for your contribution to the regulatory profession.
If you need more information, help on checking if a colleague is a Fellow who can support your application or want to discuss if your experience is likely to be sufficient to satisfy the criteria, please contact [email protected].
SPIN MANTLE MOVES ON In 2004, the Special Interest Network (SPIN) groups were drawn together under the leadership of Owen Lewellen. Owen played a vital role in establishing and promoting the concept of the SPINs and helping make the groups what they are today, including evaluating ideas for new ones, and helping to make them happen.
Now Owen has decided it is time to pass on this role. This responsibility has fallen to me and I can’t help but feel these are big shoes to fill.
Owen has been actively involved in TOPRA for many years. He was a member of the ESRA Board and helped to drive many of the activities in mainland Europe. As TOPRA members we all benefit from the activities of the SPIN groups and the high quality publications to which we have access. Owen played a big part in making these what they are today and I would like to thank him for his efforts, dedication and attention to detail.
Tim Felgate, Applied Regulatory Affairs
February 2012
TOPRA BOARD
WHO’SWhoA series in which InTouch profiles members of TOPRA’s governing body
Sarah Roberts
Sarah’s scientific background is in oncology research. Following on from her PhD she worked as a post-doc in the US at the Dana Farber Cancer Institute prior to returning to the UK and working for Cancer Research UK.
In 2002, her career in Regulatory Affairs began when she joined MDS Pharma Services, a full service CRO. It was here that she developed an in-depth knowledge
of regulatory submissions from global clinical trial submissions to global marketing authorisations.
Five years on, she joined the Development and Regulatory Services division of MDS Pharma Services as Senior Director, Regulatory Affairs, to lead the delivery of consultancy services across Europe including regulatory submissions, regulatory agency meetings and general regulatory advice. This role quickly expanded to cover a global service offering to Europe, US, Canada and Asia-Pacific. This role continued as MDS Pharma Services became Celerion, a company focusing on early clinical research (Phase I-IIa).
In January this year, Sarah joined PPD as Director, Global Regulatory Affairs Consulting, to support their Global Regulatory Affairs Development group.
Sarah has been an active member of TOPRA since 2003 and has been a member of the Editorial Panel of Regulatory Rapporteur since its inception. She is also the current Chair of the Clinical Trial SPIN group and has delivered several talks on US Regulatory Affairs for the TOPRA MSc course.
www.topra.org/intouch
K e e p i n g y o u
February 2012
NEWTOPRAMEMBERSMr Jutla amritpal Milpharm, London, uK
Dr anna Litsiou London, UK*
Mrs Lucy Williams United Therapeutics Europe Ltd, Chertsey, UK*
Ms Louise boppert ICON Clinical Research, Dublin, Ireland
Mr andrew Maguire ICON Clinical Research, Dublin, Ireland
Mrs Shruta Patel Cambridge, UK
Dr Neil roberts Gilead Sciences International Ltd, Uxbridge, UK
Mr Thomas Lueckhof Genzyme Therapeutics Ltd, Cambridge, UK
Miss Katharine Larkin Janssen-Cilag, High Wycombe, UK
Ms Nancy Smerkanich Octagon Research Solutions, Wayne, PA, USA*
Mrs Sarah beanSystagenix Wound Management Ltd, North Yorkshire, UK*
Mr Said Ikazban MSD, Belgium*
We know that many TOPRA members are visitors to the European Medicines Agency from time to time and meet up with colleagues to prepare or have a meeting de-brief afterwards. The Canary Wharf area has a number of hotels that can provide meeting rooms, but as London approaches the 2012 Olympics, availability will be an issue – and we expect prices to rocket!
So you might like to be reminded that the TOPRA Office has a meeting room that is available for our members to hire at very reasonable rates. The room can be made available from 9am to 5pm (part day bookings are possible), from Monday to Friday. It has natural light, free WiFi access, teleconferencing and presentation equipment, and can be set up to your requirements. Catering is also available: anything from hot and cold drinks with biscuits and pastries, to sandwich lunches and even hot buffets. Meetings of up to 20 people can be accommodated and TOPRA staff are happy to assist with taxis and some office support. The TOPRA offices are about 10 minutes walk from the EMA.
If you would like to enquire about availability and rates, please contact [email protected] and we will do our best to help you. The hirer must be a TOPRA member but we can invoice another company or individual on their instructions.
CongratulationsFormer TOPra board member angela Miller and her new husband Nick Stokes celebrated their wedding just after Christmas. TOPra wishes Mr and Mrs Stokes every happiness in their new life together!
inTouch editors: Jenine Willis, Greer Deal and Virginia Guellal
How to contact inTouchinTouch welcomes contributions from TOPRA members.
If you would like to contribute to the newsletter, or find out about deadlines, please contact Jenine Willis ([email protected]).
Please address any articles and correspondence to: [email protected] 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.
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 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.
CliniCal Trials SPIN Group updateThe New Year brings exciting changes for the Clinical Trials SPIN Group. We are in the process of moving to our new e-group which will be part of the TOPRA website. This should enable more members to participate in online discussions relating to clinical trials and we encourage everyone to share information, ideas and questions through the new e-group.
The Clinical Trials SPIN group has over 50 members and membership is diverse from large to small pharma, big CRO to small consultancies, so there is a wealth of experience and expertise available to tap into. The SPIN group holds regular technical teleconferences in which a variety of pertinent clinical trials related topics are discussed. Our first technical call this year will be a joint call with the CMC SPIN and will focus on clinical trials. We always welcome new members and you don’t have to be an expert to join.For further information about membership of the Clinical Trial SPIN Group email [email protected]
Ruth Lowth, CT Spin
TOPRA welcomes the following new members who joined recently.
*Registered Member
Meeting Room for Hire in Canary Wharf area – and not at Olympic rates!
