TOPRA ANNUAL REVIEW 2011/12
Annual Review
OUR VISION AND MISSION Supporting and promoting healthcare regulatory affairs To 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. Our aims are: ●
to educate regulatory professionals to the highest standards of professional competence
● to inform all members in a rapid, accurate and accessible manner of the latest
developments in global regulatory affairs ●
t o provide a forum for networking at local, regional and international levels for all professionals, whether they be in companies, agencies or working independently, so that they may share experiences and knowledge to the benefit of the whole profession
● to ●
support members in their professional careers
to raise the status of healthcare regulatory affairs and its contribution to public health throughout industry and the wider community.
TO P R A Annual Review 2011/12
These are the very visible ways in which TOPRA seeks to live out its Mission and Vision and follow the fivepoint strategic plan we have established. This plan aims to ensure that quality is embedded across the organisation and includes goals for membership in terms of growth, diversity, engagement and retention. It tasks us to further understand the environment in which TOPRA operates, and as a consequence to reach out more effectively to a regulatory affairs community that is working in a world that is changing rapidly in terms of economics, technology and legislation. Other visible evidence of how we have met these aims was seen in the excellent Annual Symposium in Rome with AIFA, which exceeded all expectations, and by the success of our second Awards for Regulatory Excellence. Both events showed regulatory affairs, and in particular TOPRA, at their best in terms of technical content, remarkable individual achievements and quality presentation, so we can all feel very proud to be members of this profession and our professional body.
There are countless less visible activities that have contributed equally to achieving our aims for the year. We continue to establish effective TOPRA in... groups across Europe to deliver local knowledge and networking to members. We have worked hard to maintain and establish relationships with all key stakeholders and TOPRA’s position as a neutral professional body has allowed cooperative working with national agencies, the European Commission and EMA in the last year, as well as industry groups, universities, government organisations and other professional associations. We have been able to re-shape our Advisory Council so that patient representation and HTA know-how are included in this eminent support group. TOPRA has been taking an active role in elements of the Innovative Medicines Initiative, ensuring that the regulatory voice is heard. This increasing breadth of interest and influence has encouraged us to establish the ‘TOPRA Roundtable’ meetings, where our most senior members can be part of a thought leadership agenda. TOPRA’s core training and education programme has been designated a ‘Centre of Excellence’ by the UK Sector Skills Council, COGENT. We have also worked to put membership of TOPRA on a more professional footing by introducing our Statement of Values to which all members subscribe. The Board of Directors has aimed to increase transparency by publishing a summary of its discussions from each meeting in the member newsletter In Touch, which this year has gone digital. Inevitably, in the current challenging environment, TOPRA has faced a few bumps along the road and the
TO P R A Annual Review 2011/12
LYNDA WIGHT
The past year has been a busy and very successful one for TOPRA. We have continued to provide our comprehensive training and education programme, to publish our highquality journal and to interact with members and especially our wonderful volunteers. During the year we have introduced a number of new events and topics to our programme and at the same time have reached out to a wider group of stakeholders.
DAVID JEFFERYS
JOINT PRESIDENT AND EXECUTIVE DIRECTOR STATEMENT
year has not been without its challenges. The decision by the University of Wales to restructure and cease the accreditation of all external courses has meant that we are working towards a new accreditation partner for January 2013. This has meant a lot of hard work but will bring new opportunities for our students who can continue to work towards a world-class qualification. Of course the economic environment has continued to be difficult for everyone, bringing pressure to bear on our members’ budgets and time. We are glad to report that by a combination of some very successful meetings and a firmly managed programme of efficiencies and cost containment, TOPRA’s financial report for the year to December 2011 was very favourable, giving us a solid foundation for the equally uncertain economic years ahead. TOPRA does all this for each and every member. We know that our core services of education, training and information provision will support members in their jobs and their developing careers. All the other activities in this Annual Report are aimed at raising the profile and standards of regulatory affairs and those who work in it. We hope this makes our members feel proud to be working in this exciting profession and proud to be part of TOPRA. DAVID JEFFERYS
LYNDA J WIGHT
President 2011-12
Executive Director
TOPRA PEOPLE TOPRA BOARD MEMBERS 2011/12
TOPRA HEADQUARTERS STAFF 2012
PRESIDENT
Lynda J Wight* Executive Director
David Jefferys (UK)
PAST-PRESIDENT Zubair Hussain (UK) PRESIDENT-ELECT Patrizia Nestby (Netherlands) EU REPRESENTATIVE Aine Kane (UK) NORTH AMERICA REPRESENTATIVE Monique Garrett (USA)
DIRECTORS Stephen Brookes (UK) Niamh Lawler-Turner (Ireland) Sarah Roberts (UK) Jonathan Trethowan (UK)
TOPRA ADVISORY COUNCIL MEMBERS 2012 Rolf Bass (Germany) Nicola Bedlington (Belgium) Daniel Brasseur (Belgium) Axel Breitstadt (Belgium) George Butler (USA) Aginus Kalis (Netherlands) Murray Lumpkin (USA) Michael Holzhauser-Alberti
(France)
Ann O’Connor (Ireland) Rui Santos Ivo (Portugal) Markku Toivonen (Finland) Mel Walker (UK) Kent Woods (UK)
Neil Fisher Director of Education & Training Christopher Bailey* Regulatory Intelligence and Training Manager Sarah Roberts-Purenins Senior Conference Coordinator Kay Wood Postgraduate Administrator Emma McNeely* Regulatory Training Executive Amifa Tholley Events Administrator Jenine Willis* Director, TOPRA Publishing Erik Smit Membership Development and Communications Manager Lisa Gordon* Membership Coordinator Madeleine Meyer* Managing Editor
MEMBERSHIP
TOPRA in
Creating a community of committed professionals
Linking members at local level
In 2011, 456 regulatory professionals from all over the globe joined TOPRA, slightly more than the previous year and 252 new members have joined TOPRA in the first six months of 2012. We welcomed our first members in Puerto Rico and Malaysia at the start of 2012.
TOPRA in groups are now established across Europe and in North America. These groups offer members the opportunity to meet with local colleagues, share information and listen to guest speakers on topics of relevance in their day to day work.
TOPRA membership now covers almost 50 countries, with concentrations of membership in the UK, USA, Germany, Ireland, Belgium, France and Switzerland.
These local networking groups offer a more conventional approach to establishing and developing a community. Each is lead by a small team of local members and networking events have been held in Ireland, Sweden, France, Italy, Switzerland, Germany, Austria, Italy and North America.
Student Membership has increased to over 100 since the category was established. TOPRA Student Members get online access to the journal, access to job opportunities, and opportunities to attend TOPRA events by assisting with event logistics – giving them a chance to meet new people, listen to key lectures and talk to exhibitors. The Student Membership category is part of a strategy of reaching out to universities to encourage science graduates to consider regulatory affairs as an exciting career option.
Wai Lang Chu Digital Editor Steve Wratten Director of Corporate Services Vincent Costello* Management Accountant Hayley King Assistant Accountant
AUSTRIA
* Part-time personnel
TO P R A Annual Review 2011/12
F R A NC E
TOPRA in NORTH AMERICA
COMMUNITY
Ensuring the global professional gets the EU message
NORTH AMERICA
In North America, TOPRA focuses on delivering practical information and training on European regulatory matters to those who have global responsibilities or who aspire to develop their careers on the international stage. Activities continued to grow in North America with an enthusiastic Leadership Team (NALT) that grew in number by 40% this year. In the last year, the TOPRA NALT has: ●
Launched the TOPRA Update Quarterly Newsletter in 2012, distributed to members and contacts across the USA and Canada
●
Sponsored TOPRA networking events in September 2011 and September 2012, with speakers on hot topics including PDUFA V, biosimilars, companion diagnostics and EU pharmacovigilance legislation
●
Co-sponsored a webinar series entitled An Overview of US and EU Regulatory Processes with the University of Wisconsin
●
Supported content development and interview coordination for the North America focus editions of the Regulatory Rapporteur, including interviewing regulatory leaders from across the continent and regulatory spectrum
●
Contributed attributed content from the Regulatory Rapporteur to the monthly publication of the Canadian organisation, CAPRA
●
Successfully conducted the Essentials of European Regulatory Affairs course in Boston, MA, and San Francisco, CA, in 2011; and in Woodcliff Lake, NJ, and Research Triangle Park, NC, in 2012.
Bringing professionals together The TOPRA community is being added to all the time, with new members joining from across the world and longstanding members wanting to keep in touch with colleagues and friends they have met through TOPRA events and shared volunteering experiences.
SPIN
TOPRA Special Interest Networks (SPIN) are communities of professionals who share common interests and wish to support each other. SPIN groups have been established for Biotechnology, Clinical Trials, CMC, Devices, e-Regulatory Affairs, Japanese Regulatory Affairs, Pharmacovigilance, Regulatory Intelligence, and Veterinary, and hold face-to-face meetings or teleconferences to share information. TOPRA e-groups have been established to facilitate virtual member-to-member networking in a collegiate environment via the TOPRA website. The TOPRA LinkedIn group now has in excess of 6,000 members and 27% of these are in senior positions. The LinkedIn group extends TOPRA’s reach into the wider regulatory community. The TOPRA website continues to develop to provide more in-depth information for the busy regulatory professional. Members value the ability to search back issues of the journal, source online management skills training, watch selected sessions from major meetings and manage their membership via the website. Separate websites to give detailed information on the Annual Symposium and the TOPRA Awards have also been set up. The website also offers tailored services in two important areas of regulatory life: in the last year the Job Shop and Services Directory have been re-vamped and offer excellent support to employers and suppliers of services as well as those searching for technical support or a new job.
G E RM AN Y
IRELAND
I T A L Y
SWEDEN
switzerland
TOPRA knows that busy professionals need to be able to keep in contact when on-the-go and has increasingly used Facebook and Twitter to keep members updated with news of events.
TO P R A Annual Review 2011/12
CONFERENCES
Relationships
Offering a neutral forum for debate and networking
Reaching out to stakeholders in the wider healthcare community
In a rapidly evolving regulatory environment, new experiences, practical concerns and ideas for future improvements need to be debated openly and constructively. The dissemination of information between all partners in the regulatory process is critical to the success of safe delivery of innovative products that can improve patient health. TOPRA conferences are developed by practising regulatory professionals and the participants are drawn from companies, agencies, consultancies, trade and professional bodies and other stakeholders, providing a rich platform for open discussion.
As part of its strategic plan TOPRA has continued to build relationships both within and beyond the healthcare regulatory community.
In the 2011-12 session TOPRA held the following key events: The 2011 Annual Symposium (October 2011) – organised in conjunction with AIFA, Agenzia Italiana del Farmaco, Rome, Italy, this meeting comprised pharmaceutical, medical device and veterinary symposia and attracted over 450 delegates The 2011 EMA Review of the Year (November 2011) – an opportinity for stakeholders to hear the challenges being faced by the European Medicines Agency and their plans for the coming 12 months. This was the sixth such event, valued by all attendees as a way of enhancing their understanding of the Agency and its work Update on the Paediatric Network (March 2012) – following on from the Enpr-EMA launch meeting that TOPRA co-ordinated in 2011, this meeting evaulated the working of the network 12 months on Pharmacovigilance – with the participation of the European Commission (June 2012) – presented on the eve of the implementation of the new PV legislation this timely meeting gave all stakeholders the chance to welcome the initiative and air practical questions and concerns The TOPRA Roundtable (September 2012) – the first in a series of occasional meetings giving senior regulatory professionals the chance to think ‘outside the box’ about how legislation may develop in the future. The first meeting looked at benefit–risk legislation and was supported by the British Institute of International Comparative Law (BIICL). TO P R A Annual Review 2011/12
As an organisation of individuals with no commercial influence, TOPRA has maintained excellent working relationships with national and European regulatory agencies, the EU Commission, other professional institutes, trade associations, government bodies, universities and increasingly with patient groups. During the year, collaborations have been agreed with RAPS (the US-based regulatory affairs Professional Society) and EUCOMED (the EU trade body for the Devices industry) and are being discussed with the Faculty of Pharmaceutical Medicine. TOPRA hosted Regulatory Affairs PhD students from the University of Southern California, USA and presented a day on developing trends in EU regulatory affairs. Meetings have been held with a number of other universities in Europe and North America. TOPRA has taken an active role in the UK Life Sciences Advisory Council and has promoted the importance of the regulatory function at the UK Department for Business, Innovation and Skills. At the EU level, TOPRA has taken an active role in IMI initiatives including PharmaTrain, EMTRAIN and EUPATI, becoming a EUPATI network organisation in 2012. The TOPRA Advisory Council has been developed in the past year to include representation for patient groups, HTA experts and universities.
PROMOTING PROFESSIONALISM
TOPRA Statement of Values
Supporting the professional regulatory scientist
Primary duty
Character and values
It is the duty of TOPRA members to advance, preserve and protect public health in the performance of their duties as regulatory affairs professionals.
● TOPRA members will act with honesty and
Regulatory professionals know that their role is pivotal to the delivery of new healthcare innovations – be they medicines or medical devices – to the marketplace. Their responsibilities start from the earliest stages of product development. The regulatory profession must embrace innovations in science and technology, keep abreast of evolutions in legislation and have the personal and business skills to manage complex projects and sensitive negotiations. Standards of integrity and professionalism are high and TOPRA is committed to ensuring that all its members have the support they need to be the best they can be. The TOPRA Life Long Learning programme delivers a framework for members to identify, address and record their learning needs and achievements. All TOPRA training and education opportunities are delivered with learning outcomes in mind and with core competencies at their heart. In 2012 TOPRA introduced its Statement of Values which all members sign up to, signifying their commitment to standards of professional behaviour (see right). TOPRA cooperated with the RAPS 2012 Scope of Practice and Compensation report, gathering information on the background, training and current role and rewards enjoyed by the regulatory profession internationally. TOPRA actively contributes to the research activities of the Professional Associations Research Network (PARN), so contributing to benchmarks of good governance and best practice in association management.
Law ● TOPRA members shall at all times conduct
themselves and their employer’s business activities in a lawful manner, both in terms of the general law of the land in which they work and also in compliance with the laws and regulations of the authorities under which they operate as regulatory professionals. ● Criminal activities which may bring the regulatory affairs profession into disrepute may result in suspension or cancellation of TOPRA membership in line with the provisions of the Memorandum and Articles of Association.
Competence ● TOPRA members will use their professional skills, knowledge and judgment to the best of their ability to deliver the best service they can as regulatory professionals. ● TOPRA members will seek to continually improve their performance and update or refresh their skills and knowledge. ● TOPRA members will recognise their limits of professional competence and resources and not seek to work beyond them. ● TOPRA members will declare any conflict of interest that they know to exist that will affect the performance of their duties.
integrity in their business activities. TOPRA members understand that accuracy and completeness of information and communications, whether written or oral, is vital in order for regulatory professionals to be trusted. ● TOPRA members will respect the confidentiality
of restricted information with which they are entrusted. ● TOPRA members will accept responsibility for the
work done by them in a professional capacity.
Conduct ● TOPRA members are respectful of others and will
treat all individuals with dignity and courtesy. ● TOPRA members will foster positive professional
relationships, and take an active interest in the professional development of those for whom they are responsible.
Awards
TOPRA AWARDS FOR REGULATORY EXCELLENCE – Applauding the best in the profession Following the success of the inaugural Awards for Regulatory Excellence in 2010, the second event was held at the Four Seasons Hotel, London in November 2011, with additional categories and an expanded eminent judging panel which included agency representatives, academic and legal specialists and representatives of patient groups. The winners of the six categories were:
NUNO SIMOES
CHRISTER BACK MAN
PAUL HUCKLE
TOPRA AWARDS
HORIZON
AWARDS AND HONOURS – Celebrating excellence in the regulatory profession
Honorary Life Membership of TOPRA is given in recognition of outstanding contribution to the world of regulatory affairs. Recipients are drawn from agencies, industry and the academic world. In 2011-12, this honour was awarded to Christer Backman (MPA, Sweden), Peter Bachmann (BfArM, Germany), Nuno Simoes (latterly of Infarmed, Portugal), Paul Huckle (GlaxoSmithKline), Leslie Whitbread (MHRA) and Guido Rasi (when Director General of AIFA). Members of TOPRA can be promoted to Fellowship following peer assessment of their experience and contribution to the profession, either within TOPRA or in the wider regulatory community. In the past year the following members have been appointed as Fellows: David Snodin, Angela Stokes, Peter Blakeney, Yves Tillet, Christine Mayer-Nicolai and Paul Jeffreys. Distinguished Service Awards, for exceptional volunteer contribution to TOPRA, have been given to Nuno Simoes for his contribution to the Annual Symposium Working parties of recent years. The TOP Team Award for 2010-11 was awarded to the Veterinary Courses Working Party which has been responsible for the Veterinary Annual Symposium for a number of years and has introduced a range of very successful new courses for this sector in the last 12 months.
Hayley Hanvey, Pfizer, UK
EDUCATION
SUPPORT
Regulis, UK
COMMUNICATION
Alison Bowers, Consultant, USA
Ann O’Connor, Irish Medicines Board, Ireland
INSPIRATION
Luis Herrera Martinez, Center for Genetic Engineering and Biotechnology, Cuba The Award was accepted by Her Excellency the Cuban Ambassador to London
ACHIEVEMENT
Professor Stuart Walker, founder of the Centre for Medicines Research and the Institute for Regulatory Science
THANKS TO OUR SPONSORS Parexel (Horizon), Thomson Reuters (Inspiration), Samarind (Lifetime Achievement) and NDA (Awards Champions) TO P R A Annual Review 2011/12
EDUCATION
Delivering qualifications for tomorrow’s leaders TOPRA is committed to offering high quality qualifications in regulatory affairs. Students 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 November 2011, at which they received their certificates from Jytte Lyngvig, Chief Executive of the Danish Medicines Agency. Awarded the Postgraduate Certificate in Regulatory Affairs: Alisdair Falconer, Noor Mohubally. Awarded the Postgraduate Diploma in Regulatory Affairs: Enid Miller, Max Corbett. Admitted to the degree of Master of Science in Regulatory Affairs: Eva Simank, Suzanna Fekete, Peter Hagger. Admitted to the degree of Master of Science in Regulatory Affairs with Distinction: Gillian Gauntlett. 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 Gillian Gauntlett. Other students graduated at ceremonies in Cranfield and Wales throughout the year. Claire Baynham attended the graduation ceremony at the University of Wales to receive her MSc with Distinction. John Greenham, Sean O’Dowd and Tina Mistry attended a graduation ceremony at Cranfield University to receive their MSc in Medical Technology Regulatory Affairs.
TO P R A Annual Review 2011/12
PUBLICATIONS
TRAINING
Providing quality information for well-informed professionals
Professional development for personal development
Regulatory Rapporteur, our peer-reviewed monthly journal has recently been cited as the primary source of regulatory information in a survey of EU professionals. During 2011-12 focus issues were published covering regulatory intelligence, paediatrics, benefit–risk, and clinical trials and there were special issues on regulatory affairs in veterinary, medical technologies and North America. Reports from the major conferences, including the Annual Symposium allow those not able to attend to read the highlights – in print or online.
The TOPRA training programme offers a structured professional development pathway for regulatory scientists.
In Touch – the monthly member newsletter – went digital in 2012. The TOPRA Guide to Regulatory Intelligence, will be the third book from TOPRA Publishing, born from the lively discussions in the TOPRA RI Special Interest group and an excellent TOPRA MSc dissertation.
The Spring and Autumn Introductory Courses have been the gold standard for new entrants for over 30 years. In 2012 the Spring course made a successful move to a new venue in Dorking, Surrey, UK. The ‘Basics of European Regulatory Affairs’ has proven to be a popular one-day introduction for very new staff and those in support roles for almost 15 years. The concept was further developed during 2011-12, following the highly successful introduction of the online version of the long-standing course. The Basics format was adapted and is now available for Medical Devices and Veterinary regulatory affairs and has been delivered as an in-house programme for regulators and lawyers. TOPRA’s provision for those in the veterinary sector was further expanded with courses offered in 2012 on veterinary variations and e-submissions. The Annual Veterinary Symposium has become increasingly popular and an enhanced programme was offered in 2012. Continuing Regulatory Education and Development (CRED) courses offer a portfolio of training opportunities on core regulatory competencies. During 2012, the TOPRA training programme was awarded the COGENT National Skills Academy accreditation as a Centre of Excellence for Regulatory Affairs and is thus an accredited supplier of such training.
TO P R A Annual Review 2011/12
Financial Report Profit and Loss for the year to 31 December
2011
2010
Turnover
1,990,913
2,123,531
Cost of sales
1,133,063
1,465,513
Gross profit
857,850
658,018
Administrative expenses
738,531
720,641
Operating Profit/(Loss)
119,319
(62,623)
Profit/(loss) on sale of investments/assets
(33,747)
12,361
85,572
(50,262)
33,402
32,282
118,974
(17,980)
Amounts written off/(back) investments
(10,772)
(26,669)
Profit (loss) before taxation
129,746
8,689
-
-
129,746
8,689
Income from investments
Taxation Profit /(loss) after taxation
The Board was pleased to be able to report a surplus for the year, despite difficult global trading conditions. All surpluses are returned to the organisation and are used to fund key initiatives in the coming years.
TO P R A Annual Review 2011/12
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