TOPRA InTouch January 2012

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 JAN 2012

2012 is likely to be a challenging, memorable and possibly a momentous year. We know there will be the Olympics and Paralympics taking place a very short distance from our offi ce in London. there will also be the celebrations for the Diamond Jubilee of Her Majesty Queen Elizabeth in the uK followed by the football European Championships in Poland and ukraine and the us Presidential election in November.

At the tOPRA/EMA Annual Review meeting last month we heard of the heavy work programme ahead of us, with the revision of the Clinical trials Directive, the extensive revision of the Medical Device Directive, implementation of the Pharmacovigilance legislation, revision of the Pricing transparency legislation and reintroduction of proposals on patient information.

this special edition of InTouch focuses on the Regulatory Aff airs Awards ceremony which was held on the evening of the fi rst day of the EMA meeting. It was a stunning evening at the Four seasons Hotel at Canary Wharf,

compered by Professor trevor Jones. the nominations and the successful shortlisted nominees highlighted some remarkable achievements and show the range of activities undertaken by regulatory professionals. they also illustrated the global outreach that tOPRA has built up.

OutstandingI would like to highlight two of the winners. the fi rst is Professor stuart Walker. stuart was the founder and remains the President of the Centre for Innovative Regulatory science.stuart received the Lifetime Achievement Award and the citation showed how richly he deserves this recognition.

He pioneered the concept of benchmarking for regulatory aff airs and all aspects of clinical development. His work signifi cantly contributed to the establishment of the new Eu regulatory system. stuart was heavily involved in the creation of ICH and he led the work on E5, the ethnic factors guideline. More recently he has championed the concept of benefi t/risk and the use of quantitative determination and display of a drug’s benefi t/risk

profi le. It was appropriate that his son was also at the dinner as a speaker at the EMA/tOPRA Annual Review.

the second recipient I would like to highlight is Luis Herrera Martinez, founder of the Center for genetic Engineering and Biotechnology in Cuba, who received the Inspiration Award. As he could not accept his award in person it was collected on his behalf by Her Excellency the Ambassador of Cuba to the uK, Mrs Esther Armenteros, who is also a personal friend of his. she described the work he has performed to develop new vaccines, most notably for meningitis.

We would like to hear your views on the Awards Ceremony. What did you enjoy and how can we make the event even better for this year? Please send your comments to [email protected]. And do start thinking about who you would like to nominate for the 2012 Awards.

Whatever the challenges in 2012, I predict that this will be a good year for tOPRA as we have an exciting programme of activities and events ahead.

AWARDS EDITIONWelcome to the Special Edition of InTouch which celebrates all that is good about Regulatory Aff airs and recent highlights of the TOPRA calendar.

In this issue:� see the winners of the

tOPRA Regulatory Aff airs Awards

� Meet the students who received their degree certifi cates

� get a taste of the celebratory evening

� Enjoy an overview of the Joint tOPRA/EMA Annual Review

� Look forward to the year ahead with tOPRA

A year of Celebration to reflect on and another to anticipateA message from David Jefferys, TOPRA President

A very happy New Year to all the readers of InTouch and to all members of TOPRA.

profi le. It was appropriate that

For more information about the Awards go to www.regulatoryaffairsawards.org

K E E P I N G Y O U

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

Our host for the evening was Professor Trevor Jones, a Past Director of the ABPI and now honorary Professor at King’s College London, who said, ‘I was delighted to be the host at the � rst event in October last year and to be part of the judging for 2011. So it is a great pleasure to be here again tonight, helping all the shortlisted nominees and the eventual winners to celebrate their success’.

Summing up the evening, TOPRA’s Executive Director Lynda Wight said: ‘Our eminent judging panel, drawn from agencies, industry, law, academia and patient groups, had a tough job to assess the excellent nominations we received in every category.

‘All the shortlisted nominees are to be congratulated in showing excellence in Regulatory A� airs. Our international list of winners from major pharma, agency, CRO sector, R&D and independent consulting shows the breadth of regulatory skill and the important contribution it makes to the delivery of safe and e� ective medicines.’

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

A STAR-STUDDED EVENING

samarindRMS

celebrates Regulatory ExcellenceThe winners of this year’s TOPRA Awards for Excellence in

Regulatory A� airs were announced at a gala celebration in

London at the Four Seasons Hotel on 24 November.

THE WINNERSHORIZONThe HORIZON Award is open to an individual with less than three years’ experience in the regulatory profession who has shown outstanding ability and promise. This year there were two very closely matched nominees who made it to our shortlist: Hayley Hanvey from P� zer, and Shilpa Jain of TRAC Services.

Hayley took the accolade for ‘work is of consistently high quality ... She handled a Mutual Recognition Procedure within three weeks of joining the company and was responsible for an Article 30 referral that was critical to maintaining supply of a product’.

INSPIRATIONThe INSPIRATION Award recognises the contribution of those who inspire their fellow professionals in their work. Three nominees made the shortlist: Kathleen Boyce of Janssen and Helen Erwood, a regulatory consultant at ESPL in Scotland, were up against an international contender Luis Herrera Martinez founder of the Center for Genetic Engineering and Biotechnology, Cuba, who took the Award.

His nomination said: ‘Luis is a much-admired person in the biotechnological � eld all over the world. His leadership by example has become an inspiration and guide for the more than 1000 workers in CIGB.’ A delighted friend of Luis’, Her Excellency the Ambassador to Cuba in the UK, Mrs Esther Armenteros accepted the Award on his behalf.

COMMUNICATIONThe COMMUNICATION Award recognises the importance of clear and e� ective communication in Regulatory A� airs. This is the � rst time this category was included in the TOPRA Regulatory A� airs Awards programme and it received a wide range of entries. Four nominees were shortlisted: John Deavin, Deavin Associates; Stuart Finnie, Astra Zeneca; Gillian Gauntlett, a Consultant; and Ann O’Connor from the Irish Medicines Board.

Ann was named the winner. She was put forward for the highest level of communication skills demonstrated throughout her career, � rstly as a hospital pharmacist, then as a senior manager in the pharmaceutical industry, in quality assurance, production, marketing and regulatory a� airs, and since 1996 as a senior professional within the IMB.

Hayley receives her Award from Paul Bridges, Corporate Vice President of Parexel, category sponsor

Her Excellency with the Inspiration category sponsor Odile le Roy Des Barres, Director of Product Management and Regulatory Information at Thomson Reuters, category sponsor

Unfortunately Ann was unable to accept her Award in person, but colleague Patrick O’Mahoney presented it to her later

A u g u s t 2 0 0 9

EDUCATIONthe EDuCAtION Award is the second new category this year. It recognises an individual, company or organisation who has made a signifi cant contribution to the world of regulatory education and training. this was the best supported category this year, which is a testament to the excellent work that is going on to support regulatory education.

the judges decided on a short list of four: Alison Bowers a Consultant – now working for Parexel in North Carolina, us; Ann O’Connor, from the Irish Medicines Board; sandra shire from Arizona state university, us; and siegfried schmitt from Parexel.

this year’s winner was Alison Bowers, who was recognised for using her substantial and broad-ranging regulatory experience and her extraordinary creativity to design, develop, deliver and evaluate numerous training solutions for a variety of in-house regulatory and clinical personnel and regulatory agency staff . One of her new Parexel colleagues, Paul Bridges, was delighted to accept the Award on her behalf.

SUPPORTthe suPPORt Award celebrates the crucial role this sector plays in supporting the Regulatory Aff airs function through regulatory consultancy, provision of extra resources and specialist services and acknowledges the importance of the quality of the work they do and the relationship between contractor and client.

the shortlisted nominees were: Idis which provided much needed support to source and supply an unlicensed medicine to help save a baby’s life at the great Ormond street Hospital in London; the IDRAC product team who worked with customers to re-shape their regulatory intelligence tool; Regulis, which provided outstanding support for a new company; and tRAC services which worked with a client to always deliver projects on-time, reliably and creatively.

All four companies had delivered outstanding service in the 18-month window prescribed by the category conditions. the value of that support is evidenced by the clients being willing to make the nomination!

Regulis was announced the winner for providing global support in a timely manner, going beyond the call of duty when working with markets in very diff erent time zones.

The Parexel team celebrates Alison Bowers’ achievement in winning the Education Award

A proud Kim Wharton receives the Award from judge Ali Harrison on behalf of his Regulis team

Professor Walker receives his Award from Miranda Pothiawala, Software Director of Samarind, category sponsor

this was a very diffi cult job to do this year as nominations were received for some outstanding candidates, but one man stood out. Professor stuart Walker who has given lifelong service to Regulatory science. He founded the Centre for Medicines Research and built this to become arguably the premier group for benchmarking both research and development in the pharmaceutical industry and the regulatory process.

Accepting the honour, stuart said: ‘I realise how fortunate I have been to be in the right place at the right time working with the right people which has resulted in this recognition and Life time Achievement Award. I have been privileged to work with the leaders of research and development within the pharmaceutical industry... My career to date has given me the opportunity to develop systems and strategies for effi cient drug development and the regulatory review. In particular, within CIRs we have been able to develop the tools that are necessary to improve regulatory submissions and their review – more recently, particularly in the last 10 years, my focus has been on the methodologies and frameworks for benefi t/risk assessment.

‘Perhaps in conclusion I could quote from sir Isaac Newton who said “If I have seen further than others, it is because I have stood on the shoulders of giants.” It only remains therefore for me to say once again a big thank you to tOPRA for giving me this award. It is something that I will value for the rest of my life.’

LIFE TIME ACHIEVEMENTThe crowning glory of the Awards event was the Life Time Achievement Award, which is assessed by the entire judging panel.

A u g u s t 2 0 0 9

K E E P I N G Y O U

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

Our host for the evening was Professor Trevor Jones, a Past Director of the ABPI and now honorary Professor at King’s College London, who said, ‘I was delighted to be the host at the � rst event in October last year and to be part of the judging for 2011. So it is a great pleasure to be here again tonight, helping all the shortlisted nominees and the eventual winners to celebrate their success’.

Summing up the evening, TOPRA’s Executive Director Lynda Wight said: ‘Our eminent judging panel, drawn from agencies, industry, law, academia and patient groups, had a tough job to assess the excellent nominations we received in every category.

‘All the shortlisted nominees are to be congratulated in showing excellence in Regulatory A� airs. Our international list of winners from major pharma, agency, CRO sector, R&D and independent consulting shows the breadth of regulatory skill and the important contribution it makes to the delivery of safe and e� ective medicines.’

THE TOPRA NE WSLE T TER – KEEPING MEMBERS IN TOUCH

A STAR-STUDDED EVENING

samarindRMS

celebrates Regulatory ExcellenceThe winners of this year’s TOPRA Awards for Excellence in

Regulatory A� airs were announced at a gala celebration in

London at the Four Seasons Hotel on 24 November.

THE WINNERSHORIZONThe HORIZON Award is open to an individual with less than three years’ experience in the regulatory profession who has shown outstanding ability and promise. This year there were two very closely matched nominees who made it to our shortlist: Hayley Hanvey from P� zer, and Shilpa Jain of TRAC Services.

Hayley took the accolade for ‘work is of consistently high quality ... She handled a Mutual Recognition Procedure within three weeks of joining the company and was responsible for an Article 30 referral that was critical to maintaining supply of a product’.

INSPIRATIONThe INSPIRATION Award recognises the contribution of those who inspire their fellow professionals in their work. Three nominees made the shortlist: Kathleen Boyce of Janssen and Helen Erwood, a regulatory consultant at ESPL in Scotland, were up against an international contender Luis Herrera Martinez founder of the Center for Genetic Engineering and Biotechnology, Cuba, who took the Award.

His nomination said: ‘Luis is a much-admired person in the biotechnological � eld all over the world. His leadership by example has become an inspiration and guide for the more than 1000 workers in CIGB.’ A delighted friend of Luis’, Her Excellency the Ambassador to Cuba in the UK, Mrs Esther Armenteros accepted the Award on his behalf.

COMMUNICATIONThe COMMUNICATION Award recognises the importance of clear and e� ective communication in Regulatory A� airs. This is the � rst time this category was included in the TOPRA Regulatory A� airs Awards programme and it received a wide range of entries. Four nominees were shortlisted: John Deavin, Deavin Associates; Stuart Finnie, Astra Zeneca; Gillian Gauntlett, a Consultant; and Ann O’Connor from the Irish Medicines Board.

Ann was named the winner. She was put forward for the highest level of communication skills demonstrated throughout her career, � rstly as a hospital pharmacist, then as a senior manager in the pharmaceutical industry, in quality assurance, production, marketing and regulatory a� airs, and since 1996 as a senior professional within the IMB.

Hayley receives her Award from Paul Bridges, Corporate Vice President of Parexel, category sponsor

Her Excellency with the Inspiration category sponsor Odile le Roy Des Barres, Director of Product Management and Regulatory Information at Thomson Reuters, category sponsor

Unfortunately Ann was unable to accept her Award in person, but colleague Patrick O’Mahoney presented it to her later

TOPRA President David Jefferys opens the graduation ceremony

Noor Mohubally

Gillian Gauntlett

Graham McCleod

Gillian Gauntlett receives the Veronica Skeffington Prize from Jytte Lynvig (right)

Mary Day

Thank you to our sponsors!TOPRA would like to say a special thank you to our sponsors who came on board this year to demonstrate their commitment to Regulatory Affairs and all the people who work in this vital healthcare sector.

Without such sponsorship, TOPRA would find it very hard to put on such a high profile event and celebratory evening which benefits the whole Regulatory Affairs profession as well as recognising those special people who were nominated and recognised through the judging process – both as shortlisted nominees and eventual winners.

Our thanks go to● Samarind for their support

for Life Time Achievement ● Thomson Reuters for their

support of Inspiration ● Parexel for their support

of Horizon● NDA for their general support

as Awards Champions ● Ash as Media supporters

This years successful students

Postgraduate Certificate in Regulatory Affairs

Alisdair FalconerNoor Mohubally

Postgraduate Diploma in Regulatory Affairs

Enid MillerMax Corbett

Master of science in Regulatory Affairs

gillian gauntlett (with Distinction)Eva simanksuzanna FeketePeter Hagger

Postgraduate Certificate in Medical technology Regulatory Affairs

James RiddellNeil Purcellgunhild Paulsen

Master of science in Medical technology Regulatory Affairs

Nicola Bradley

Master of science in Medical technology Regulatory Affairs

graham McCleodMary Day

Over the years, tOPRA has established an excellent reputation in regulatory education in large part due to the Msc courses we run; the Msc in Regulatory Affairs, validated by the university of Wales and the Msc in Medical technology Regulatory Affairs run by tOPRA in conjunction with Cranfield university. At any one time between 80 and 100 students will be working their way through these modular programmes which are designed to deliver the most up to date, high quality and practical training to help students do their current jobs better, whilst offering opportunities for research, debate and networking that will ensure they develop into the best regulatory managers of the future.

tOPRA President, David Jefferys hosted the ceremony. He said: ‘I would like to pay my own tribute to this evening’s graduates: they have all studied for their qualifications while holding down responsible and often challenging jobs. they have applied themselves in their precious spare time to improving themselves and their value to their employers and we should not underestimate how much hard work this entails. they can all be very proud of their achievements and I’d like you to join me in saying a general “well done” to them all!’

Graduates take centre stage

The celebratory evening started with the TOPRA 2011 Graduation Ceremony where four of our most recently successful MSc graduates were presented their certificates by our special guest, Jytte Lynvig, the CEO of the Danish Medicines Agency. Jytte is also a TOPRA Honorary member, a member of our Advisory Council and a judge for our Awards.

Veronica Skeffington PrizeEach year a special award is made to a student who is considered to have performed at the highest possible level in their studies. the Veronica skeffington Prize in honour of the tOPRA member who led the development of the course and was a lead examiner for many years and this year it was awarded to Msc Regulatory Affairs graduate, gillian gauntlett.

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

The Pfizer team celebrate the success of colleagues Hayley (centre) and Noor (second right)

Communication shortlister John Deavin in conversation with Odlile le Roy Des Barres from Thomson Reuters

The guests enjoy a wonderful dinner and then entertainment from Hot Strings

Helen Erwood, shortlisted for Education, enjoys the evening with a colleague

Judges Mary Baker and Sam Salek meet the Cuban Ambassador (left)

The NDA team (below) support the event as an Awards Champion

Board member Sarah Roberts and Communication shortlister Stuart Finnie chat with a guest

Former board member Margareth Jorvid (left) and judge Ali Harrison

Education shortlister Sandra Shire came all the way from the US to participate in the ceremony

Past President Zubair Hussain (centre) mingles with some of the guests

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K E E P I N G Y O U

JANUARY 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 ([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.

© 2012 the Organisation for Professionals in Regulatory Affairs

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InTouch is free to tOPRA members. Annual membership of tOPRA is €220. tOPRA members can read or download InTouch online at www.topra.org

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LOOKING FORWARD: EMA sHAREs Its PRIORItIEs FOR 2012 Last month’s Joint tOPRA/EMA meeting was a fi tting fi nale to an eventful year for tOPRA. this annual event was again well attended by regulators and industry representatives alike. the conference took place on 24-25 November in the EMA building itself. the programme covered a wide range of issues, highlighting many of the challenges and practical steps that are taking place to deal with an ever-changing regulatory environment.

Challenges for the EMA in 2012-2013• the impact of budgetry restraints which will lead to reprioritisation

and reallocation of resources – in particular to help implement the new Pharmacovigilance legislation

• An increasing emphasis on transparency and a drive to proactive disclosure of information and greater input from patients

• Revisions of the Clinical trials and the Medical Devices directives• greater emphasis on the particular needs of special patient groups,

such as the elderly and children.

In the spirit of transparency, session 4 focused on the way the EMA works with presentations from staff in key areas, eg gCP inspections, Risk Management, etc. the opportunity to fi nd out who does what at the EMA was much valued by delegates, as was the Q&A session that followed.

there is not enough space to go into great detail about the programme here, but we have collated a few highlights to give a fl avour of the meeting. You will be able to read fuller reports of all the sessions in an early edition of Regulatory Rapporteur this year.

LOOKING FORWARD: PLANNINg FOR IRELANDPlans for the 2012 Symposium are well underway. The Working Party (see picture below), which includes several senior IMB staff , has decided on a wide range of topics to cover, including: Scientifi c Advice, Clinical Trials, Access to Medicines, the Centralised Procedure (CP) and Rapporteur selection, falsifi ed medicines, switching of Prescription-Only Medicines to Over-The-Counter, Patient Information, Pharmacovigilance (please note topics may be subject to change). In addition, a number of parallel tracks will be included and of course the Medical Devices and Veterinary Symposia will once again run alongside the Pharmaceutical Symposium. All to take place on 1-3 October 2012 in Dublin, Ireland.

LOOKING FORWARD: PLANNINg FOR IRELANDthe 9th tOPRA Annual Symposium 2012LOOKING FORWARD:

Plans for the 2012 Symposium are well underway. The Working Party (see picture below),

LOOKING FORWARD: the 9th tOPRA Annual

EMA Executive Director Guido Rasi opens the proceedings

Spiros Vamvakas answers delegates’ Q&A questions

The conference was held in the EMA’s meeting rooms