K E E P I N G Y O U

In this issueIt’s great to see organisations across the globe come together to improve the welfare of others. What is particularly heart-warming, though, is to see the role that Regulatory A� airs professionals can play at a global level. With the support and passion of TOPRA behind us, we can all make a di� erence.

The development of new drugs is important but so too is the availability of generics and biosimilars particularly to the developing world. TOPRA is asking members about their interest in this area so please email spin@topra.org.

The global theme continues with Lynda Wight’s successful visit to North America which included discussions with RAPs and TOPRA’s North America management group (see page 3).

Greer Deal, Co-Editor

The objective of the summit was to sign the London Declaration, which commits the parties to work to eradicate ten major neglected tropical diseases by 2020.

The initiatives agreed consist of significant enhanced donations of existing medicines, the development of new medicines and a commitment to additional research. The meeting demonstrated unique partnerships between the pharmaceutical industry and other organisations such as DNDI (Drugs for Neglected Disease Initiative) and governments.

The meeting received considerable publicity at the time, and this will probably increase as the benefits are rolled out to almost two billion people. There are other similar programmes. Last October eight major pharmaceutical companies opened their patent libraries allowing researchers access to develop medicines for neglected tropical diseases and other

related conditions. This was the so-called WIPO initiative.

I am highlighting these events as they signify a major switch within the healthcare industry. It is now right at the forefront of delivering solutions to many of the world’s most intractable problems. Eradication of neglected tropical diseases will bring untold benefit to individuals but will also help lift whole societies out of poverty. This kind of leadership presents industry at its very best: seeking to deliver healthcare solutions across the world.

ImportanceWhy is this of importance for Regulatory Affairs professionals? In my view there are two reasons. First, RA professionals are intimately involved in delivering such solutions through the registration of the products, sometimes using the national routes and sometimes using the WHO prequalification procedure. Regulatory

Leading the way in promoting accessA message from David Je� erys, TOPRA President

On 30 January a meeting at the Royal College of Physicians in London brought together the CEOs of all the major pharmaceutical companies, Bill Gates (representing the Gates foundation), the Director General of the World Health Organization, the World Bank and Health Ministers from a range of developing countries together with participants from the voluntary sector.

professionals are also heavily involved in the strategic planning for the development of many of these products. Second, the perception of our industry matters critically for those of us in Regulatory Affairs. We know at first hand how highly regulated it is. Negative perceptions are particularly frustrating for regulators in companies and agencies who strive to deliver medicines to improve patient health.

The day after the London Summit I travelled to Washington and took part in a very successful discussion between TOPRA and RAPS. The theme of these high-level discussions was to enhance collaboration and leadership of the RA profession between our two organisations (see page 3).

One of the items touched on was how we, in the profession, can play our part in supporting better access to medicines in developing counties and supporting key global initiatives.

Register your interest in a Generics SPINIn January, TOPRA successfully exhibited at the EGA Regulatory and Scienti� c A� airs Conference in London. Owing to the importance and size of the generics sector, as well as the fact that more than a third of our members have expressed an interest in this area on our database, we are looking to become more active in generics and biosimilars.

We would like to hear your views on this. Would you be interested in a course on Generics? Would you be interested in joining a Generics SPIN Group if one was set up?Let us know your views at spin@topra.org

Erik Smit

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 MARCH 2012

On 30 January a meeting at the Royal College of Physicians in London brought together

K E E P I N G Y O U

TOPRA is a member of the Professional Associations Research Network (PARN) which o� ers support and guidance on best practice to professional bodies and membership organisations. They conduct original research which can help assess the attitudes of professional people to a range of issues.

One such piece of work, which TOPRA is supporting, is a research programme into e-learning. PARN has worked with a number of organisations across a spectrum of professional disciplines to develop a questionnaire to determine the use of and attitudes to this mode of learning. The results will be made available for TOPRA speci� cally and for all respondents so this will give us some very helpful information to inform how we move forward into e-learning in the future.

Please take some time to complete this survey, which will be

emailed to you and will be open until 30 April 2012. Your input is very important to TOPRA ‘getting it right’ for our members. We’ll present a summary of the main � ndings in InTouch. In the meantime, if you have any ideas, observations or other information you’d like to share with us on this and related topics, please don’t hesitate to tell us!

If you can’t recall the e-learning material that TOPRA provides already, please visit our website to see the links to interactive online courses and video material. We have an online Basics course (see back page), interactive web-based training courses on management skills, and a number of videos from key meetings including Annual Symposia , which include copies of the presentation material that can be accessed individually or as a package.

E-learning – what do YOU think?

TOPRA Awards Update 2012It’s time to prepare your nominations!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 A� airs Awards.

E-le

arni

ngE-

lear

ning

Entries open on 12 March!There are seven categories so you will definitely find an Award to match your regulatory ‘star’:

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 and deadlines go to: www.regulatoryaffairsawards.org

Supporting the AwardsTOPRA 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.

‘IDRAC from Thomson Reuters is proud to sponsor the 2012 TOPRA Education Award. As a long-standing supporter of Regulatory Affairs training programmes, Thomson Reuters recognises the critical impact individuals and organisations can make to the world of regulatory education and professional development,’ says Claude Basset, Vice-President of Product Management.

There are many opportunities for companies to support 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 sponsoring the Awards, please contact Mark Wilkins, by email mark.wilkins@ashridgecommunications.com or telephone: +44 (0)1753 714999.

Join us for the Awards ceremonyWe are pleased to confirm 28 November as the date for TOPRA’s Regulatory Affairs Awards ceremony. The Awards will be held at the Radisson Blu Portman Hotel (pictured above) located in the heart of the West End of London, UK.

TOPRA Sta�

WHO’SWHOA series in which InTouch pro� les members of TOPRA’s o� ce team

Jenine Willis - Director of Publishing Services

She is responsible for managing all TOPRA’s publications – from Regulatory Rapporteur to our booklets – and developing the website and enhancing social networking opportunities for members.

Jenine regards the TOPRA Awards as one of her key achievements to date, she says: ‘I’m proud to have helped set up and successfully run the TOPRA RA Awards, which are a great way of recognising the commitment and excellent work of RA professionals in improving healthcare.’

She has 25+ years’ experience as a journalist in healthcare publications, including Nursing Times and Scrip Magazine. Her previous full-time role was Editor of the Good Clinical Practice Journal at Informa Healthcare, and this included managing the Brookwood Booklets and Clinical Research Reports for a while. She also has a Masters degree in Health Studies.

What does she enjoy most about working for TOPRA? ‘The role is very varied so no day is the same! It’s great to have so much contact with RA professionals and to be working on publications and websites that can really make a difference in helping our members in their day-to-day life, and to know that, ultimately, this can contribute to improving public health.’

Members should contact Jenine for information/help with TOPRA communications, publications, website, advertising/sponsorship opportunities and the TOPRA Regulatory Affairs Awards. Just email jenine@topra.org.

Jenine leads the TOPRA Publishing team whose focus is providing excellent information services and high-quality communications for members – and the wider RA community.

It has been a busy time for TOPRA in North America. At the end of January Executive Director, Lynda Wight paid an informal visit to the FDA facility at the White Oak Campus in Silver Spring MD. Those who have been there will agree that it is an impressive campus which is still in development.

Later that week, she accompanied TOPRA President David Jefferys to the headquarters of RAPS where discussions were held on how the two organisations can best serve their members in their respective constituencies. A number of ideas were put forward and you will hear more as these are taken forward over the next year or so.

One initiative that was agreed immediately was for TOPRA to encourage its members to participate in the RAPS global ‘Scope of Practice & Compensation’ Survey. This research helps understand the changing roles and responsibilities of regulatory professionals in the healthcare sector, and also gives information on the levels of salary and benefits for professionals at all levels of experience.

TOPRA’s support for this will allow the two organisations to work together to jointly evaluate the needs of the profession, so that both can support the development of Regulatory Affairs as a whole while providing the tools our respective members need for their individual career development.

The survey will take about 10-20 minutes to complete and is completely anonymous and confidential. You will get an email from TOPRA about it in early March and the survey will be open until the end of the month. Visit the TOPRA website to get the link or look out for the embedded link in the survey email.

A few days later, members of TOPRA’s North America management group met for their annual face to face meeting in Summit New Jersey under the leadership of TOPRA Board member Monique Garrett. A day of valuable discussions was held on topics including membership, training, networking events, the role of the TOPRA Consultation team in NA, the web page and the special issue of the journal that will cover US matters. The team has an ambitious programme of activities for the coming year so do pass the message onto your colleagues that TOPRA is there to support those in the US and Canada who need to have a global focus or would benefit from a greater understanding of European regulatory matters.

TOPRA in North America- recent activities

TOPRA Executive Director Lynda Wight toured the impressive FDA facility in Silver Spring, MD, while on a trip to Washington to have discussions with RAPS.

E-learning – what do YOU think?

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

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

MARCH 2012MARCH 2012

K E E P I N G Y O U

NEWTOPRAMEMBERSDr Susan Linda VojvodicReckitt Benckiser Healthcare, Hull, UK*Mrs Fiona BrightLetchworth Garden City, UK*Mr Mark Brookes Gilead Sciences, Cambridge, UKMrs Jill SegevGilead Sciences International, Great Abingdon, UKMr Sou� ane DibReckitt Benckiser Healthcare, UK*Ms Rachel ShannonAstraZeneca Pharmaceuticals, Ireland*Mr David ClarkeGilead Sciences International, Great Abington, UKMrs Emma BarryGW Pharmaceuticals International, Salisbury, UKMr Tim GaleGilead Sciences International, Cambridge, UKMr Ronan GrimesAthenry, Ireland*Dr Antonia OrsiSalupont Consulting, Sandy, UK*Miss Zehra OkaygunSinclair IS Pharma, Chester, UKMrs Julie Shepherd-SmithAptiv Solutions, High Wycombe, UK

Mr Thomas RobinsonReckitt Benckiser Healthcare, Hull, UK*Miss Rebecca GibbsGW Pharmaceuticals, Salisbury, UKMr Claude BeroWill-Pharma, Wavre, Belgium*Mr Peter PringleReigate, UK*Mr Ankit GondaliyaUK*Dr Mireille MullerSwitzerland*Mr Kevin BeecheyMylan, Hertfordshire, UK*Mr Mario WijkerAmerican Medical Systems, The Netherlands*Mrs Gemma JonesHull, UK*Mr Scott SimpsonShire Pharmaceuticals, Basingstoke, UK*Ms Mairead Du� yMerck Sharp and Dohme, IrelandMr Chamunorwa MiauziNottingham, UK (Student Member)Mrs Storme Haarho� Gilead Sciences International, Great Abington, UKDr Sandra Beltran-RodilTeva Pharmaceuticals Europe, Harlow, UKDr Sebastian SpechtF Ho� man-La Roche, Basel, Switzerland

Mr James CarrollGlaxoSmithKline, USAMr Paul BrittJohnson & Johnson, High Wycombe, UKMr Jes Schmidt-PetersenFerring Pharmaceuticals, Copenhagen, DenmarkMrs Rachel EtgesGregory Fryer Associates, Ely, UKMrs Jodie FernandesLondon, UKMiss Alison CoyleGilead Sciences International, Cambridge, UKMiss Valerie SalenteyCytheris, Issy-les-Moulineaux, France*Mrs Carolyn BoothbyAstraZeneca, Maccles� eld, UKDr Paul StreetAstraZeneca, Maccles� eld, UK*Mrs Marga Paterson-SmitKinesis Pharma, Breda, The NetherlandsMr Guy d’EstaisRome, ItalyMs Christina ChuckWilkris & Co, Stockholm, Sweden*Ms Stella AngHyphens Pharma, SingaporeMs Orla FinneranRoscommon, Ireland (Student Member)

Mrs Valerie GordenneOdyssea Pharma, Grace-Hollogne, BelgiumMiss Emma HagbergNorwich, UK (Student Member)Mr Alexis CazeNew York, USAMrs Shilpa KawarkheRuislip, UK*Mr Anil WalunjRuislip, UK*Mrs Tanja FranolicTakeda Global Research & Development Center, London, UK*Ms Sarah CaldwellPhiladelphia, USA (Student Member)Ms Emer O’NeillKill, Ireland (Student Member)Mrs Karen BradleyBoehringer Ingelheim, Bracknell, UKMr Anil KhedkarHaverhill, UKDr Dhara KapadiaCambridge, UKMrs Gemma PuckeyPPD, Cambridge, UKMr Henrik HannusLondon, UKMrs Jasmine ChananaPPD, Cambridge, UKDr Kathryn ParsleyPPD, Cambridge, UKLynsey EdenPPD, Cambridge, UK*

Dr Susana RochaPPD, Cambridge, UKMr Vikram SoundalePPD, Cambridge, UKMrs Dolores AguilarLaboratorios Sophia, Zapopan, Mexico*Mrs Helen SeurinNewmarket, UK*Mr Matthew BurtonJensonR+, Barnstaple, UKMiss Emily AyresJensonR+, Barnstaple, UKMr Neil PrideauxJensonR+, Barnstaple, UKMrs Sonja SeebergerSchriesheim, Germany*Mr Aneel MarshallLondon, UK (Student Member)Miss Emma AncillSano� -aventis – Zentiva, Guildford, UK*Mrs Karen GoldingAstraZeneca, Maccles� eld, UK*Miss Caroline DoyleSEQ, Isle of Man, UKMs Vaishali KhedekarReckitt Benckiser Healthcare, Slough, UKMr Ergun KocGilead Sciences International, Cambridge, UK

100th delegate takes the Online Basics Course

TOPRA welcomes the following new members who joined recently.

At the recent MSc Module 10 course held in Munich Germany, Vlada Suslova, Bayer’s Head of Regulatory Affairs and Certification Department, Moscow, Russia, was presented with a bottleof Champagne to celebrate the 100th sale of TOPRA’s Online Basics course. The presentation was made by Neil Fisher, TOPRA’s Director of Education & Training.

The Online Basics course was purchased by Bayer as part of their continued staff training and development. ‘This 100th sale has taken less than a year from the launch and is a significant landmark for TOPRA’s online training capabilities,’ says Neil.

Following the successful reception of the Online Basics, TOPRA plans to develop more

online courses and training programmes to enhance the existing provision and provide a learning mode that will be available for members and other healthcare regulatory professionals who do not have access or the travel capability to attend face-to-face courses.

Neil Fisher

www.topra.org/intouch

MARCH 2012

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 (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 edi-tors or TOPRA. While every effort is made to ensure information is accurate, conditions may change and readers are advised to con-sult current official texts and/or to seek appropriate professional advice before taking any regula-tory action.

© 2012 The Organisation for Professionals in Regulatory Affairs

TOPRABellerive House3 Muirfield CrescentLondon E14 9SZ

Tel: +44 (0) 20 7510 2560Fax: +44 (0) 20 7537 2003E-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 Organisation for Professionals in Regulatory A� airs 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.

*Registered Member