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JOINT PRESIDENT AND EXECUTIVE DIRECTOR STATEMENT

In the twelve months since our last Annual Review was published, the healthcare sector has been subject to increasing pressures as the global economic situation has deteriorated. The possible effect of such pressures on our own activities was at the forefront of the minds of Board and staff when developing our strategy for the next few years. We knew that being responsive to changes in the external economic environment, and indeed in the specific regulatory environment, would be crucial to our continuing success and relevance to our members. Our strategic plan has five main objectives: to respond to the changing external environment; to respond to the changing regulatory environment; to increase our membership; to improve communications within and outside the organisation, and in all things to improve quality. This report of our activities will demonstrate that we have made significant progress in all these strategic aims.

Our record-breaking 2010 Symposium in London, in partnership with MHRA, was an inspirational start to the TOPRA year, reminding us of the increasing breadth of responsibility of regulatory professionals. Our first-ever Awards ceremony reminded us of professionals that give innovative and inspirational support over a lifetime of service in regulatory affairs. The success of the ‘TOPRA In’ initiative has brought more members into direct engagement with us. Furthermore, for those who have new restrictions on time and travel, the introduction of the e-Basics course and the ability to network ‘virtually’ via our Special Interest (SPIN) Networks and Linked In groups has been invaluable as well as the ability to search our journal Regulatory Rapporteur on-line. Our daily news e-lerts, regular e-newsletters and TOP RA Job bulletins have supplemented the monthly information in In Touch, helping all members keep informed.

In tough times, membership of a professional association is more important than ever: keeping knowledge refreshed, sharing information with others, building useful business networks, learning new skills, accessing career coaching services and most of all showing commitment to being the best you can be in a dynamic and challenging profession, are all benefits of TOPRA membership. We will continue to provide this service, and much more, in the years ahead.

Zubair Hussain Lynda WightPresident 2010 -11 Executive Director

MEMBERSHIP – continuing to grow and engageMembership numbers continue to rise. In 2010, 451 regulatory professionals from all over the globe joined TOPRA. Over 300 members have joined TOPRA in the first eight months of 2011. In this period we welcomed our first members from Mexico, Mauritius, Taiwan, Ukraine and Ghana.

The ‘TOPRA In....’ brand has been launched for local member groups, to allow TOPRA members to network and also reach out to their colleagues in the same country. Set-up meetings and some follow-on events have been held in Sweden, Ireland, Austria, Italy and Switzerland, with more planned in France, Germany, Czech Republic, and further afield.

TOPRA In North America continued an active programme with the launch of ‘Essentials of EU Regulatory Affairs’ – a training programme for seasoned regulatory practitioners who need more understanding of the EU situation – and regional networking events. Co-operation with local groups in North America continued and collaboration with AAPS resulted in two successful TOPRA sessions at their annual meeting in New Orleans in November 2010.

IRELAND

AUSTRIA

I T A L Y

switzerland

VISION

Supporting and promoting healthcare regulatory affairs.

MISSIONTo be the professional organisation

providing high quality education,

training, information, support

services and networking

opportunities for those involved

in all aspects of healthcare

regulatory affairs, so supporting

individuals in their career

development and promoting the

profession as a whole.

The President’s Award to the Board member making the most significant contribution for the year 2009-10 was awarded to Margareth Jorvid at the 2010 Annual meeting. The award for 2010-11 will be presented to Prof Paolo Biffignandi at the 2011 Annual meeting.

Honorary Life Membership of TOPRA for service to TOPRA and/or the wider regulatory community was awarded in 2010 to Rick Clayton (IFAH), Irene Sacristan Sanchez (EU Commission), Ann O’Connor (IMB) and Gabi Disselhoff. In early 2011 this honour was also bestowed on Dr Susanne Ludgate (MHRA), Prof Steve Dean (VMD) and Dr Peter Jones acknowledging their contributions to Medical Device and Veterinary regulatory affairs and to Dr John Purves, winner of the first TOPRA Lifetime Achievement Award. Past Presidents of TOPRA who also accepted this award in 2011 were Brian James, Cheryl Hall, Margareth Jorvid and Alan Hunter.

In the year from October 2010, Fellowships were awarded to Ali Harrison, Jonathan Trethowan, Neil Armstrong, Alan Morrison and Hilde Viroux.

Distinguished Service Awards, for exceptional volunteer contribution to TOPRA, have been given to Steve Harston, Carlos Langezaal and Patricia Duchene.

The TOP Team Award for 2010-11 was awarded to the 2010 Annual Symposium Working Party, chaired by Alan Hunter.

TOPRA AWARDS FOR REGULATORY EXCELLENCE

A glittering ceremony celebrated the very best in regulatory affairs. The eminent judging panel drawn from industry, agencies and academia had considered an encouraging field of nominations and made their choices of the winners in five categories.

For 2011 the Awards have been expanded to include two new categories that further celebrate the breadth of regulatory activity: Communication and Education. New judges from the education, business and patient sectors have been added to the prestigious panel. Sponsorship from Samarind, Thomson Reuters and NDA Regulatory demonstrates recognition of the importance of regulatory affairs in healthcare. The 2011 winners will be announced at a ceremony in November 2011.

AWARDS and HONOURS –celebrating the best in the regulatory profession

Horizon WinnerSAkSHI CHHABRA

inspiration WinnerJONATHAN TRETHOWAN

innovation WinnerSAMARIND RMS

support Winner RRG CONSULTANCY

acHievement WinnerJOHN PURVES

celebrating the best in the regulatory profession

Admitted to the degree of Master of Science in Regulatory Affairs:

Kwame AnsahChristine BuggeCorinne Philippe-ReversatSam TarantinoStella AugustusMelissa WhitlockKatherine ChorltonRina Pankhania

Awarded the Postgraduate Certificate in Medical Technology Regulatory Affairs:

Jeremy AllenNeil PurcellJames RiddellGunhild Paulsen

Admitted to the degree of Postgraduate Certificate in Regulatory Affairs:

Claire RayHarriet Lugg

Admitted to the degree of Postgraduate Diploma in Regulatory Affairs:

Jonas HenningsenSusanne AldenSarah ThornSimon HotchinErin BrooksGraham LakerRuth Lowth

Admitted to the degree of Master of Science in Regulatory Affairs with Distinction:

Ruth CurleyDavina StevensonMateja Pfajfar

Each 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. This year it was awarded to Davina Stevenson

Admitted to the degree of Master of Science in Medical Technology Regulatory Affairs:

Deidre BarrowHilde VirouxHilary MongeyIan HooperNicola Ann BradleyMary DayGraham McLeod

The Course Director’s Prize for the MTRA MSc went to Graham McLeod

EDUCATION – supporting career development in a changing environmentStudents from the TOPRA MSc in Regulatory Affairs (validated by the University of Wales) and the MSc in Medical Technology Regulatory Affairs (Cranfield University and TOPRA) graduated at the TOPRA Awards ceremony in London in October 2010, at which they received their certificates from Professor Sir Alasdair Breckenridge, Chairman of MHRA. Other students graduated at ceremonies in Cranfield and Wales throughout the year.

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INFORMATION and COMMUNICATIONS – keeping members informed and connected

Our Journal, Regulatory Rapporteur, had a redesign of its masthead and continued to develop as the leading peer-reviewed journal of record and opinion in regulatory affairs.

Our member newsletter In Touch brought monthly news to all members – with a web page for further news and views.

Electronic communication via daily e-lerts from Pharma Times and TOPRA e-newsletters kept members informed about their organisation and the regulatory world at large. The TOP RA Jobs e-mail service proved very popular throughout the year.

The TOPRA ‘Linked in’ Group of over 3,000 members offers an additional opportunity for information sharing and debate, with topics ranging from the need to have a group to support regulatory intelligence professionals, through CTA approval problems in Europe and GMP inspection experiences in Pakistan.

Our Website developed throughout the year to include interviews with key regulatory figures, webcasts from important meetings, searchable back copies of the journal and e-learning opportunities.

CONFERENCES AND MEETINGS – keeping abreast of regulatory change

Highlights of the 2010 –2011 year have included... ● The Annual Symposium in London,

including the Medical Devices Symposium and the Veterinary Symposium – with the support of MHRA – October 2010

● The 5th joint meeting with EMA – December 2010

● Launch of the Paediatric Network at EMA – March 2011

● First Veterinary ‘Basics’ course – March 2011

● In-house training at DG SANCO – March 2010

Our second book was published and ’Careers in Regulatory Affairs’ joined ‘Evaluating Medicines’, available to purchase from TOPRA or via Amazon®.

Media profile maintained with TOPRA appearing in 60 journals and on over 15 websites. Publications include features on pharmacovigilance, paediatrics and regulatory careers.

SPINgroups

● The 16th Autumn Introductory Course in Prague – November 2010

● The 33rd Spring Introductory Course – May 2011

● Plus a full programme of Basics and CRED courses, special courses on e-CTD

All TOPRA courses and meetings carry Lifelong Learning hours to allow attendees to build up their continuing professional development portfolio.

e-learning Modules for the popular ‘Basics of Regulatory Affairs’ course were available from January 2011 for those who cannot attend face to face events.

SPIN groups allow members to network with colleagues with similar interests through e-mail, teleconferences and webinars. Current SPIN groups include: CMC, Japan, Devices, Regulatory Intelligence, Biotech, Clinical Trials, Veterinary RA, e-RA and Pharmacovigilance.

TOPRA Board 2010/11 our p

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eFINANCIAL ACCOUNTS

Profit and Loss for the year to December 31st

2010 2009

£ £

Turnover 2,123,531 2,111,499

Cost of sales 1,465,513 1,450,003

Gross profit 658,018 661,496

Administrative expenses 720,641 725,987

Operating profit/(loss) (62,623) (64,491)

Profit/(loss) on sale of investments/assets 12,361 (13,102)

(50,262) (77,593)

Income from investments 32,282 35,349

(17,980) (42,244)

Amounts written off/(back) from investments (26,669) (113,202)

Profit before taxation 8,689 70,958

Taxation - -

Profit after taxation 8,689 70,958

OUR PEOPLETOPRA BOARD MEMBERS 2010/11

PRESIDENT Zubair Hussain (UK)

PAST-PRESIDENTPaolo Biffignandi (Italy)

PRESIDENT-ELECTDavid Jefferys (UK)

EU REPRESENTATIVEAine Kane (UK)

NORTH AMERICA REPRESENTATIVEMonique Garrett (USA)

DIRECTORSMargareth Jorvid (Sweden)Angela Miller (UK)Patrizia Nestby (Netherlands)Niamh Lawler-Turner (Ireland)

TOPRA ADVISORY COUNCIL MEMBERS 2010/11

Rolf Bass (Germany)

Daniel Brasseur (Belgium, EU)

George Butler (USA/UK)

Kent Woods (UK)

Noel Wathion (EU)

Aginus Kalis (Netherlands)

Jytte Lyngvig (Denmark)

Markku Toivonen (Finland/UK)

Tamas Paal (Hungary)

Ann O’Connor (Ireland)

Graham Higson (UK)

Murray Lumpkin (USA)

Michael Holzhauser-Alberti (France)

TOPRA HEADQUARTERS STAFF 2010/11

Lynda J Wight – Executive Director

Neil Fisher – Director of Education and Training

Steve Wratten – Director of Corporate Services

Jenine Willis – Director, TOPRA Publishing

Christopher Bailey – Regulatory Intelligence and Training Manager

Erik Smit – Membership Development and Communications Manager

Emma McNeely – Regulatory Training Executive (from June 2011)

Patricia Philippi Marketing Executive (to May 2011)

Lisa Gordon – Membership Coordinator

Sarah Roberts-Purenins – Senior Conference Coordinator

Deanne Prudden/Natalia Lada – Training and Events Coordinator (to May 2011)

Kay Wood – Postgraduate Administrator

Madeleine Meyer – Managing Editor

Vincent Costello – Management Accountant

Tania Eulitz – Assistant Accountant

Hayley King – Office Services Coordinator/Assistant Accountant (maternity cover)

www.topra.org

The Organisation for Professionals in Regulatory Affairs Ltd

Bellerive House, 3 Muirfield Crescent, London E14 9SZ, United Kingdom

Tel: +44 (0)20 7510 2560, Fax: +44 (0)20 7537 2003, Email: topra@topra.org