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TOPRA Annual Report to members 2012/13

Vision

Enabling and promoting excellence in the healthcare regulatory profession

Mission

To represent and promote the global healthcare regulatory profession; and to provide members with top-quality, relevant support with a European focus

www.topra.org

TOPRA Annual Review 2012/13


INTRODUCTION AN ACTION-PACKED YEAR FOR TOPRA

At the Annual Review Meeting in November 2013, the TOPRA Board reported to the membership on the activities of the past year. This report gives details of how TOPRA has continued to support its members, speak for the regulatory professional and promote the importance of regulatory affairs in the delivery of safe and effective healthcare solutions.

The TOPRA Board 2013. From L–R: Steve Brookes, Director; Patrizia Nestby, President; David Jefferys, Past President; Niamh Lawler Turner, Director; Jonathan Trethowan, President Elect; Aine Kane, Director – Europe; and Sarah Roberts, Director.

Board Members 2012–2013 PRESIDENT

Dr Patrizia Nestby

Past President

Dr David Jefferys

President Elect

Dr Jonathan Trethowan

Director – Europe

Dr Aine Kane

Director – North America

Dr Patricia Duchene

Directors

Niamh Lawler-Turner Stephen Brookes Dr Sarah Roberts Dr Christine Mayer-Nicolai Ljiljana Markuš Cizelj (to July 2013)

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TOPRA Annual Review 2012/13


PRESIDENT’S REPORT SIGNIFICANT PROGRESS IN ‘FUTURE PROOFING’ YOUR PROFESSIONAL BODY As I draw to the end of my Presidency I can reflect with some pride on the significant progress we have made in the last year. Not all of this has been in our more ‘public’ activities: we have had a deep focus on the future direction of TOPRA as it enters into its second decade, so that we can be sure that we have ‘future proofed’ your professional body for the challenges and opportunities ahead.

Patrizia Nestby

We developed a seven-point strategy with projects that will take up to 2015 to implement fully and which included: ●

To effectively communicate TOPRA’s neutral positioning, revised vision/mission and memberships benefits to the world-wide regulatory community To become a respected provider of high quality and modern online ‘virtual’ services in order to increase accessibility of TOPRA services to members worldwide To grow and broaden the membership to include more non-UK members and all regulatory affairs professionals including those from regulatory agencies To further expand TOPRA In groups while ensuring that these are of clear benefit to TOPRA To further examine strategic partnerships to determine if they can assist TOPRA in achieving its strategic aims in terms of membership development and provision of online services To become a respected partner in facilitating debate on regulatory topics in a neutral, non-partisan environment as an independent professional association for the benefit of the whole profession To develop progression pathways for personal development via our education and training course – and identify an academic pathway for regulatory professionals.

The fruits of some of this activity will be apparent in the following report. Other developments will take longer and you will see them in 2014 and beyond. It has been an honour to serve as your President over this last year and to make my contribution to TOPRA. I would like to thank my fellow Board members for their support and encouragement and wish my successor, Jonathan Trethowan, every success as he continues with the direction we have established. Patrizia Nestby President 2012–13

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TOPRA Annual Review 2012/13

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EXECUTIVE DIRECTOR’S REPORT RENEWED FOCUS ON MEMBERSHIP COMMUNITY ACTIVITIES

As any chief executive of a membership body will tell you, the role combines the need to manage a ‘business’ while retaining the flexibility and sense of community that comes from the involvement of volunteer members in delivering the business objectives. TOPRA is extremely fortunate in the number and quality of the volunteers it can call upon and each and every one makes a valued contribution. We are also fortunate in that we have the staff resource we need to support the 40-plus events we hold each year, to ensure our publications reach members in good time and to a high quality and to take on additional tasks as we explore new avenues. In the past year we have added (for the first time) an experienced staff member to be Head of Membership and this will allow us to do more to support members as individuals as well as the community as a whole. One development that will follow from this will be the installation of a new integrated member database which will allow each member to engage with TOPRA directly and be aligned more effectively to colleagues who have similar interests. In November 2012, TOPRA launched the TOPRA Annual Lecture, which preceded the Regulatory Affairs Awards for Excellence Dinner and Ceremony. The inaugural lecture, entitled Is the regulatory profession fit for the future? was delivered by Professor Sir Michael Rawlins, former head of NICE. I hope that this report will emphasise how much TOPRA has achieved in the past year and in reading it you will become equally enthused about the exciting prospects that lie ahead as we enter our second decade. Lynda Wight Executive Director

EXECUTIVE DIRECTOR

Lynda J Wight*

Regulatory Intelligence and Training Manager

Christopher Bailey*

Regulatory Training Executive

Emma McNeely*

Conference Logistics Manager

Sarah Roberts-Purenins

Postgraduate Administrator

Kay Wood

Events Coordinator

Amifa Kebe Kamara

DIRECTOR, TOPRA PUBLISHING

Jenine Willis*

Marketing and Communications Manager

Erik Smit

Managing Editor

Madeleine Meyer*

Digital Editor

Amanda Little*

Communications Coordinator

Rachel Cook

DIRECTOR, CORPORATE SERVICES

Steve Wratten

Management Accountant

Vincent Costello

Assistant Accountant

Hayley King

Office Services Coordinator

Katie Whitehead

HEAD OF MEMBERSHIP

Duncan Judd

Membership Coordinator

Lisa Gordon*

*Part-time personnel

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TOPRA Annual Review 2012/13


FINANCIAL REPORT FOR YEAR TO 31 DECEMBER 2012 AND PREVIOUS YEAR COMPARISON

Profit and Loss for the year to 31 December

2012

2011

Turnover

2,146,265

1,990,913

Cost of sales

1,150,987

1,133,063

Gross surplus

995,278

857,850

Administrative expenses

740,334

738,531

Operating Profit/(Loss)

254,944

119,319

804

(33,747)

255,748

85,572

35,974

33,402

291,722

118,974

Amounts written off/(back) investments

(15,637)

(10,772)

Surplus before taxation

307,359

129,746

-

-

307,359

129,746

Profit/(loss) on sale of investments/assets

Income from investments

Taxation Surplus after taxation

The improvement in turnover was largely attributable to a very successful Annual Symposium in Dublin, Ireland. Increases in direct costs and administrative expenses were minimal resulting in an improved surplus, which was added to reserves to be used for future developments. These will include the implementation of the new database and the expenses of a move of office premises in 2014. We will also be investing in more ‘virtual’ services for professional development.

www.topra.org

TOPRA Annual Review 2012/13

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MEMBERSHIP REACHING OUT TO REGULATORY PROFESSIONALS – EVERYWHERE

Member numbers overall have increased compared to the same period last year. Since October 2012 TOPRA has welcomed 393 new Members (as at 1 October 2013) and over 60 new Student Members. Membership has also become more diverse with more countries being represented demographically. In 2012–13 we welcomed new members in Dubai and Uruguay for the first time, and had a particularly encouraging growth of membership in Ireland, Switzerland and the Netherlands. TOPRA now has members from 53 countries. In 2014 TOPRA will be introducing a new CRM web system that will enable members to access much more information, manage their membership, utilise many more new functions online and increase their capacity to network. The new Head of Membership was appointed in May 2013 and will be developing a strategy to engage existing members personally and to attract more new members from all sectors.

The professional network of membership is a valuable support.

Engaging with students is an important strategic objective. 6

www.topra.org

Duncan Judd, Head of Membership. TOPRA Annual Review 2012/13


COMMUNITY NETWORKING – FACE-TO-FACE AND ONLINE – TAKES CENTRE STAGE

Active Special Interest Networks (SPIN groups) exist for Clinical Trials, CMC (Chemistry, Manufacturing, Controls), Electronic Regulatory Affairs, Medical Technologies, Pharmacovigilance, Regulatory Intelligence and Veterinary. These create the ability for neutral and independent discussion in a ‘safe’ environment, in a face to face or virtual context. Each has a management team of volunteers to plan activities and input into TOPRA’s overall activities, and an e-network for on-line information sharing. Active TOPRA In networks are based in Switzerland, Sweden, Spain, France, Italy, Portugal, North America, Ireland and Austria. Each network holds meetings which bring professionals together either face-to-face or via teleconference. The meetings are based on current regulatory hot topics and give members a great opportunity to network, raise their profile and gain regulatory intelligence. The most recent TOPRA In meetings have been based in Ireland (at the Irish medicines Board), Sweden (at the Medicinal Products Agency) where members have discussed various topics and in Switzerland with Swiss Medic. During the year some TOPRA In groups have joined together for shared e-meetings on topics of mutual interest. The meetings are not only networking opportunities but also a source of up-to-the-minute information and members have enjoyed discussions on e-submissions, e-CTD, falsified medicines and many other subjects in recent months. In 2013 we introduced e-newsletters on the recent discussions at the TOPRA In events and SPIN meetings. These e-newsletters have been successful in offering information to the wider network who could not attend the meetings and help keep members up-to-date on developments. TOPRA In North America has seen developments with a strong core of individuals in its steering group, and a wider consultation group. This group has been reaching out to members in the state regions, helping them become more involved, engaged and gain more from their membership. Over the year the North America volunteers have presented the Essentials of EU Regulatory Affairs training seminar as public and in-house events and have established a series of webinars in partnership with the University of Wisconsin. This group also leads on a North America focused issue of the Regulatory Rapporteur journal annually. TOPRA is working in partnership with RegNed in The Netherlands, MEGRA in Germany and BRAS in Belgium to facilitate networking between regulatory professionals.

Meeting up with colleagues in learning situations, on social occasions and at the Annual Symposium. www.topra.org

TOPRA Annual Review 2012/13

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COMMUNICATIONS TAKING A DIGITAL DIRECTION

Over the year we have focused on making the website easier to use, with clearer layouts, tighter writing and a more logical structure. The emphasis of the home page has shifted to attracting new members and to highlighting news items of interest to regulatory professionals, refreshed at least once a week. Visits to the website increased by about 5% over the previous year, and unique visitors by nearly 9%. By improving our search engine rankings we have made it easier for potential customers to find our courses, job vacancies and publications. We also improved the use of images online to showcase TOPRA’s many activities. TOPRA’s LinkedIn group has continued to flourish and now has over 8,000 members, while we have smaller but growing followings on Twitter and Facebook. Regulatory Rapporteur continues to be a respected source of regulatory information. In 2012–13 topics for focus issues included geriatric medicines, pharmacovigilance, Latin America, resources and management, clinical trials, advanced therapies, OTC products, biotechnology and North America. There was increased coverage of Device and Veterinary topics. A full archive of the journal is also available to members to search online. The members’ newsletter InTouch was published monthly, keeping members up to date with the Board’s activities, new developments and news of colleagues. The third TOPRA book, The TOPRA Guide to Regulatory Intelligence, was published in 2012.

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www.topra.org

TOPRA Annual Review 2012/13


AWARDS AND HONOURS FELLOWSHIPS, DISTINGUISHED SERVICE AWARDS AND HONORARY LIFE MEMBERSHIPS In the past year, Fellowship of TOPRA was awarded to: Liz Gifford, David Kane, Patrizia Nestby, Rachel Morten, Emma du Four, Lorraine Marsh and Tacye Connelly. Distinguished Service Awards were awarded to TOPRA volunteers who had made a particular contribution: Andy Thorley, Rohit Malhotra, Margareth Jorvid, John Deavin, Aaron Cousins, Janis Bayley, Alexander Geddes, Alan Hunter and Craig McCarthy. Honorary Life Membership of TOPRA was awarded to: Richard Bergstrom, Tony Humphreys, Paolo Biffignandi and Craig McCarthy.

REGULATORY AFFAIRS AWARDS The third TOPRA Awards for Regulatory Excellence were held in November 2012 at the Portman Hotel in London and the winners were announced as follows: ●

COMMUNICATION Hilde Boone (EMA) and Janice Soreth (FDA) EDUCATION Frances Richmond, University of Southern California, USA HORIZON Jenny Gray, Regulis Consulting UK INSPIRATION Henrietta Ukwu, USA INNOVATION Gerald Thompson, The Boots Company, UK SUPPORT Melanie Carr and the SME Office at EMA LIFETIME ACHIEVEMENT Dr Bill Vandaele

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Left column top–bottom: Jenny Gray with judge Chris Griffet; Henrietta Ukwu from PPD; and Hilde Boone from EMA and Janice Soreth from US FDA Right column top–bottom: Frances Richmond; Gerald Thompson and Miranda Pothiawala, Samarind; Constantinos Ziogas, Melanie Carr with judge Mary Baker; and Bill Vandaele with TOPRA President Patrizia Nestby.

TOPRA Annual Review 2012/13

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EDUCATION QUALIFICATIONS COME TO THE FORE – MSc AND PhD DEVELOPMENTS During 2012 TOPRA successfully achieved the transfer of its flagship MSc course from University of Wales to the University of Hertfordshire. The validation report offered commendations to TOPRA on the extensive expertise of the module leaders and teachers, the excellence of the case studies, and the breadth and currency of the course. The TOPRA MSc in Medical Technologies continued to develop as part of a suite of healthcare-related programmes at Cranfield University, and will be of especial value to students in the period of legislative change that will occur in the next two years. The following students graduated in the past year: Postgraduate Certificate

Shakilah Mujtaba Elizabeth Purdy

Postgraduate Diploma with Distinction

Andreas Potthoff Marta Szadkowski Spela Zibelnik Stupar

Postgraduate Diploma

Janina Dzambazoska Barbara Mravinec Chidi Wek Eva Skrlj

MSc with Distinction

Julia Anne Lenihan Claire Roche (winner of the Veronica Skeffington Prize) David Smith

MSc

Jeffrey Adamson Mateja Antoncic Christine Degeling Alenka Drazumeric Ursula Hopff Dipti Patel Siwan Thomas

MSc in Medical Technologies

Paul Browning Robert Hofland Sarah Bean Angela Robertson

Both MSc programmes offer the individual modules to non-students as short courses. TOPRA is a partner in the IMI PharmaTrain initiative to introduce a recognised MSc syllabus for Regulatory Affairs across a number of EU Universities. The University of Hertfordshire signed the Memorandum of Agreement to be part of this initiative in August 2013. In July 2013 the contract between TOPRA and Cardiff University was signed to allow the introduction of the TOPRA PhD in Regulatory Affairs. The first applicants are under consideration with the first student expected to start in October 2013.

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TOPRA Annual Review 2012/13


PROFESSIONAL DEVELOPMENT MAKING THE MOST OF LIFE-LONG LEARNING OPPORTUNITIES

TOPRA has continued to present a programme of training, conferences and opportunities for debate to support all regulatory professionals in their personal and technical development. The Basics programme continues to be popular, with pharmaceutical, veterinary and device versions being used as the template for tailored training to groups as diverse to patent lawyers and EU Commission employees. The two long-standing Introductory Courses have been joined by a third programme for Medical Devices. In calendar year 2012, excluding TOPRA In events and MSc Modules, TOPRA presented 34 training courses and conferences, from 1 to 5 days in length, in Germany, USA, France, Belgium, Ireland and the UK. Over 320 speakers delivered presentations to almost 1000 delegates of whom 47% were based in the UK and 46% from Europe. In October 2012 TOPRA held its largest Annual Symposium at University College Dublin, in partnership with the Irish Medicines Board. In October 2013, TOPRA went to Lisbon, with a successful Symposium in partnership with Infarmed, Portugal. In 2013 the TOPRA Roundtable initiative was introduced to allow senior professionals the forum for open debate and challenging the status quo. During 2013 TOPRA was accepted as a member of the Science Council, underscoring the important scientific nature of regulatory affairs and skills of its practitioners.

BUILDING A WIDE RANGE OF PARTNERSHIPS In addition to active participation in IMI initiative including EMTRAIN and EUPATI, TOPRA has partnered with ISoP (the International Society for Pharmacovigilance) on a meeting on PV legislation, and has signed an agreement with RegNed, the local society in The Netherlands, to run joint events. TOPRA continues to be an active partner with the Sector Skills Council COGENT supporting their Life Sciences Advisory Council and other networks aimed at bringing excellence to training and development in the life sciences industries. Exploratory meetings have been held with RAPS and DIA Europe to evaluate the potential for partnerships in selected areas. TOPRA met with RQA (The Research Quality Association) to explore areas of common interest. TOPRA has participated in meetings of the European Pharmacy Students Association to promote regulatory affairs as a career. A joint meeting was held with JPAG, which included a site visit to EDQM. Strategic partnerships will continue to play an important role for TOPRA as we extend our reach and add value for our membership.

www.topra.org

TOPRA Annual Review 2012/13

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Looking to the future 10 Years of TOPRA TOPRA will celebrate its 10th birthday in January 2014 and in the following year the next steps will be taken to further develop services, support members and increase visibility on the world stage. Included in these plans are: ●

Installation of the new membership relationship database to aid communications and personal interaction

Increased offering of high-quality e-services complementing the traditional face-to-face meetings and learning

The introduction of additional opportunities for personal development and accreditation

The evolution of refreshed branding for our second decade

All these developments will be showcased in InTouch and communicated to members via regular e-newsletters and other media.

IN CONCLUSION... The Board believes that the year 2012-3 has been a successful one for TOPRA in many ways. The financial success in 2012 provided security for the more challenging conditions we have been experiencing in 2013, meaning that TOPRA has the resources, provided they are managed prudently, to take forward its stated vision. The Board would like to thank every member, and in particular those who give of their time and talents as working party members, editors, committee leaders, speakers and in many other ways to help us achieve our objectives. Thank you to all our members, volunteers and partners for your support in 2012–13.

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 Web: www.topra.org

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