CELEBRATING 40 YEARS 1977-2017
Driving quality and integrity in scientific research The Association was originally formed in 1977 as the Quality Assurance Group of the United Kingdom or QAG (UK). It was renamed the British Association of Research Quality Assurance (BARQA) in 1991 and became an incorporated company (limited by guarantee) in 1997. Then, in 2012, the Board and Members agreed to a change of name to reflect the international nature of its activity – it became the Research Quality Association (RQA). Since its inception, the Association has expanded and developed to reflect the changes in regulatory requirements, government inspections and the needs of professionals. In 2017 we celebrate 40 years of RQA and reflect on some of the more memorable moments.
celebrating 40 years 1977-2017
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1976-1989 1976 • First round table discussions at ICI and HRC – nine companies and 15 people.
1981 • QAG (UK) became an open group and was no longer restricted to one member per company.
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companies
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International Congress held in Rome, 1981
1982 • 2 nd International Congress held in York. 1983 • 3 rd International Congress held in Copenhagen. 1984 • A nnual meeting held in Rugby.
people
1977 • QAG (UK) was officially founded; there is no formal record of this. 1978 • First QAG (UK) meeting held in Loughborough • First newsletter published – one single-sided A4 page. 1979 • Second QAG (UK) meeting held in Norwich. 1980 • Third QAG (UK) meeting held in Edinburgh.
1985 • 4 th International Congress held in Cambridge • Annual meeting held in Northampton. 1986 • 5 th International Congress held in Frankfurt • F irst public training course held in Loughborough • A nnual meeting held in Birmingham. 1987 • A nnual meeting held in Harrogate. 1988 • 6 th International Congress held in Stratford-upon-Avon • F ERQAS proposed by Membership Review Committee • W orking Parties formed for biotechnology, field trials and physico-chemical testing • A nnual meeting held in Brighton. 1989 • A nnual meeting held in Edinburgh.
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2 RQARQA CELEBRATING 40 YEARS 1977-2017
1990-1999 1990 • 7th International Congress held in Cannes and organised jointly with SoFAQ • Spanish and Swiss societies established • First Regional Forum meeting (Home Counties/Anglia/South Midlands) • Annual Conference held in Cardiff. 1991 • First meeting of the Board • First Scottish Regional Forum meeting • QAG (UK) renamed British Association of Research Quality Assurance (BARQA) • First meeting with JSQA – Japan Society of Quality Assurance • Annual Conference held in Chester. 1992 • 8th International Congress held in London • First Members’ Directory published • First Diploma in Research Quality Assurance • Committees formed from existing Sub-Committees and Working Parties • The Institute of Biology takes over some of the Association’s administration • Annual Conference held in York. 1993 • First glossy newsletter is published • First Diploma graduation ceremony • Annual Conference held in Bath. 1994 • 9th International Congress held in Barcelona and organised jointly with SEGCIB • GMP Committee formed • Vicky Kyle joins BARQA as the Association’s first employee • Annual Conference held in Stratford-upon-Avon.
1995 • 10th International Congress held in Glasgow • The Association opens an office in St Ives, Cambridgeshire • Vicky Kyle leaves the Association • John Wenn of Anglia Polytechnic University takes over some of the administration • David Weller appointed to the post of Association Manager • Annual Conference held in Bournemouth. 1996 • 11th International Congress held in Manchester • Animal Health Working Party formed • Newsletter Editorial Board formed • The Association Strategy is published • Overseas members’ grade is discontinued • Annual Conference held in Gosforth. 1997 • 12th International Congress held in Brighton • Association’s office moves to Ipswich, Suffolk • BARQA becomes an incorporated Company limited by guarantee • Animal Health Working Party becomes the Animal Health Committee • Members Directory is produced in ‘yearbook’ format. 1998 • 13th International Congress held in Glasgow • Newsletter renamed Quasar and is produced in full colour • BARQA website is launched • Annual Conference held in Stratford-upon-Avon. 1999 • 14th International Congress held in Dublin • Email chat lines are opened • First intake on MSc in Quality Management • Annual Conference held in Harrogate.
2000-2017 2000 • 15th International Congress held in Edinburgh. 2001 • 1 6th International Congress held in Prague • New membership structure introduced • Annual Conference held in Bristol. 2002 • New auditing skills courses launched • Annual Conference held in Manchester. 2003 • New Postgraduate Certificate, Postgraduate Diploma and Masters programme launched • New BARQA livery • GCLP Guideline published • Annual Conference held in Nottingham. 2004 • 17th International Congress held in Dublin • Annual Conference held in Liverpool. 2005 • Auditor’s Passport Scheme pilot launched •G LP and Field Studies Committees merge • Good Pharmacovigilance Practice Committee formed • Annual Conference held in Edinburgh.
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global qa conference in orlando, florida sqa/jsqa/ barqa, 2005
2006 • New look website and Quasar launched • Continuing Professional Development (CPD) Scheme for Auditors launched • Australasian Regional Forum launched • Annual Conference held in Bournemouth. 2007 • Annual Conference held in Harrogate.
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edition of the Quasar newsletter published 2008 • 2nd Global QA Conference in Edinburgh - BARQA/SQA/JSQA • New MSc in Quality Management in Scientific Research and Development. 2009 • Membership, product purchasing and event booking available online • Annual Conference held in Brighton. 2010 • First Distance Learning courses launched • Annual Conference held in Leeds. 2011 • 3rd Global QA Conference in Kyoto – JSQA/BARQA/SQA • Annual Conference held in Bristol. 2012 • BARQA renamed as the Research Quality Association (RQA) • India Regional Forum launched • Online Members’ Directory launched • Website relaunched • Medical Devices Committee formed • Annual Conference held in Bristol.
2013 • 1st European QA Conference with DGGF and SoFAQ in Bonn • Webcasts launched • David Weller retires. 2014 • 4th Global QA Conference in Las Vegas – SQA/JSQA/RQA • Anthony Wilkinson appointed as Association Manager • Electronic booklets launched • CRM system purchased • Significant rise in social media presence reported • Net Promoter Score introduced to measure satisfaction • Annual Conference in Brighton. 2015 • US Regional Forum created • Association Board restructured • Management Committee created • Association Manager becomes Director of Operations • Membership satisfaction survey restructured • Global Engagement Team formed • First webinar broadcast • Electronic training course notes launched • Annual Conference held in Leeds.
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2016 • 2nd European QA Conference in Nice • Education and Training Committee disbanded • Finance Committee disbanded • eNewsletter launched • Volunteer Programme launched • Annual Conference held in Brighton. 2017 • RQA becomes a member of the CPD Certification Centre • Quasar is given a makeover – new look and feel • Website is relaunched with new intuitive design • CRM system is launched • 20th Anniversary of incorporation as a Limited by Guarantee company.
5
th GLOBAL
CONFERENCE TO BE HELD
IN EDINBURGH
the association is 40 years old!
the number of categories THE RQA WAS shorTlisted for IN the Association Excellence Awards 2015 celebrating 40 years 1977-2017
3
3
service to the association
founder members
*
CHAIR PICTURED T Treasurer S Secretary A RQA Award
RAY BROAD* 1977
GRAHAM MOSS* 1983
ken shilLam* 1985
Bryan Doherty 1988
1978
T Ritchie Thompson S Graham Moss
1986
T Des Hoare
Irene Herod 2000
S Nigel Dent
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RQA
T Harold Neal A Rosemarie Corrigan A Judith Elliott
1989
T David Ford
S Peter Richer
2003
A David Colinese A Graham Ogg
A Penny Bearne A Mary O’Flaherty
1991
T John Maple
Ronnie Constable 2004
Nigel dent 2002
2001
A Ramzan Visanji
Sydney Trenchard-Morgan 1990
A Ray Broad
Penelope Bearne 2006
2005
A Roger Chapman
A Nigel Dent
T David Bailes
2007
A Andrew Waddell
A Rodney Pateman A John Varley
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CHAIRS Janice Birnie 1994
1993
S Janice Birnie A Peter Richer
T John Turner S Diane Clements A Ken Shillam
Andrew Waddell 2008
Jim Elvy 1996
1995
S Stella Pullum A Bryan Doherty
T Mary Drew A Graham Moss
Rachel Hodges 2010
2009
A Rachel Hodges
of committee members
OVER 40 YEARS 1977-2017
Tim Stiles 1992
A Parascevas Joannou
102 in 2017 total number
A Sydney Trenchard-Morgan
S Sheila Macrae A Hugh Frith A June Garner
Louise Handy 2012
A David Butler A Joy Eldridge
Sally White 1999
T Pamela Nickols S David Weller A Janice Birnie
A Jim Elvy A Tim Stiles
1997
2011
T Roger Chapman A Mark Goodwin A Iain McPhee
Paul Last 1998
David Butler 2014
2013
A Andrew King A Vanessa Grant
T David Bailes A Alan Pipe A Colin Wilsher
Vanessa Grant 2016
2015
A Irene Brownlee A Paul Strickland
A Tracy Gilbert
T Roger Cope A Louise Handy A Kerry Bunyan
celebrating 40 years 1977-2017
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Member CoNtributions
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RQA
Tim Stiles
W
ith the publication of the draft FDA GLPs in the late 1970s, a handful of individuals tasked with the responsibility of implementing the GLP proposals in their respective organisations got together to assist and support each other in this endeavour. From this small group grew the Research Quality Association (RQA) as we know it today.
The fundamental objectives of that group, to share knowledge and assist other members, has been the underlying principle of RQA throughout its 40 year existence and it continues to be one of its endearing attributes today.
chairman 1992-1994 Director of Qualogy Ltd
Over the 40 years, there have been numerous individuals who made significant contributions to the development of the group, two that spring to mind are Bryan Doherty (ICI/Zeneca) who developed and expanded the focus of organisation and Sydney Trenchard-Morgan (Toxicol) who transformed the QAG into BARQA. Many others played their part, such as Peter Richer (Unilever) and Betty his wife who I recall produced mail shots to all members on their kitchen table, in the early days this required a lot of licking stamps and envelopes. Whether a large or small involvement of so many individuals, RQA’s success then, as it is now, is a testament to the army of volunteers who have previously and continue to contribute their time, knowledge and expertise for the benefit of others. To all of those individual contributors, congratulations, the past and present success of RQA is down to you.
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louise mawer
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ell what can I say, 40 – that makes you the same age as my youngest sister who will celebrate her 40th in November, around the time of the Annual Conference. I started in QA by accident, not by design. I applied for a Laboratory Manager post at a Phase I unit and got offered the role of QA Officer. “You’d be good at that” my Line Manager commented. “What is QA?” “Finding fault… but in a nice way… you’re good at it.”
I have to admit, after practising now for a while, I’m still not sure if I’m good at it, but I’ve had a bit of help from the key opinion leaders in the field. Memories include my first BARQA training course at Madingley Hall (An Introduction to GCP), which I remember for eating too much food, drinking possibly a few too many glasses of wine and far too few hours of sleep and my first Annual Conference in Bristol, in which again there seemed to be too few hours of sleep, a Jacuzzi and a stormtrooper?
Member 1995-present Consultant Auditor, Mirabilitas Ltd
My RQA heroes are all my diploma colleagues with whom I studied avidly in Cambridge, I remember meeting Tom Selleck (and being abandoned by my diploma chums when I chose to greet him… no it wasn’t him, just in my mind!), getting up at a stupid hour to watch football before we studied for the day (no I’m not a fan but I’m sure there was a man called Karel involved) and then having an ethical debate (truly! Almost like a proper debating society). I think of my generous mentors like Rodney Hill (a gentleman and the perfect person to guide a lady round the dancefloor, or me, in the absence of a lady), Gail Wood (always a positive comment and kind manager), Barry Travena (with an interest in science with history and a Yorkshireman’s philosophy) and Hugh Frith, who first sparked my interest in “finding fault… but in a nice way”. I remember them all with a smile and hope that perhaps there are one or two new people to quality assurance, GxPs and research who might similarly look back in time and think on the support, advice and friendships established through just being a member of the association.
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RQA
Andrew Waddell
I
am not (quite) a founder-member of RQA (or the ‘Quality Assurance Group’ as it was then known) but it was still a small and intimate organisation when I joined in 1980. In those days, it was one member per company and our annual meeting might attract 20-30 attendees.
Even in these early days we recognised the importance of training and our first course was organised at Keele University. Thirty-five years later, I’m still tutoring on courses and enjoying the experience. We also recognised the importance of international engagement but early international meetings never seemed to be without incident. Delegates at our 1981 International Congress in Rome were visiting St Peter’s Square when there was an assassination attempt on the Pope. Travel to the 1986 meeting in Frankfurt was disrupted by the Chernobyl disaster and members attending the San Diego meeting in 1989 left just before the earthquake struck.
chairman 2008-2010 Director OF TMQA
Recent meetings have been more tranquil and I have a personal interest in it remaining that way for the 5th Global QA Conference in Edinburgh this year. Few of the small band that formed the QAG 40 years ago could have foreseen the growth into the powerful, international body it is today. The strength of the RQA is its membership and our current strength is testament to the commitment and vision of innumerable members, past and present.
celebrating 40 years 1977-2017
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Kenneth Shillam
L
epore’s Proposed Regulations came out as 21 CFR Part 58 in November 1968 (I believe) and became law in the US 10 years later, after everyone concerned had had their say (I remember I did). I was officially appointed Head of QAU in April 1977 and I believe Graham Moss of Fisons had just been to ICI to discuss with Ray Broad what these strange GLPs were all about.
They decided they needed me in on the act and the three of us met at HRC in April 1977. At this point the QAG could be considered to have been born – but we decided we needed the input (and output) of like-minded individuals in other companies. But we had no funds and so had to restrict ‘membership’ to one person per company. The first meeting proper was held at ICI, the second at HRC and whoever volunteered held the next 10-12 thereafter. At the first few meetings were Richie Thompson of IRI, Mike Smith of Reckitts, James of Shell, Zoltan Berczy of Biotox, plus others from Unilever, Colworth House, Roche, Glaxo, Beecham, Hoechst, Burroughs Wellcome and Farrell. Not all came to all meetings of course.
chairman 1985-1988
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RQA
There is as far as I can see, no defining moment when it all began, unless you consider the first meeting between Ray Broad, Graham Moss and myself. From then on the RQA as we now know it, just grew!
Barney Horne AND Anna Tillmann arney and Anna met through the GCP Committee in 2005. We were quietly dating, trying to keep it from GCP Committee colleagues, until we decided to go public by announcing our engagement at the 2007 BARQA Annual Conference in Harrogate.
B
RQA Committee member 2003-present senior director qa, daiichi sankyo
RQA Committee member 1995-present Vice President Global Quality Assurance & Compliance
Following the GCP Forum (a fringe event at the time, a forerunner of the now established and popular GxP Clinics), we chased away stragglers from the meeting and cracked open some bubbly to celebrate with GCP Committee colleagues. Being expert auditors, all the Committee Members (bar one, we won’t reveal who) had already guessed, but were far too professional to say anything!
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THE RQA OFFICE Celebrating the RQA’s 40th anniversary provides a great opportunity to see what the office does and how it has changed over the years. In the early years the Quality Assurance Group (QAG) UK didn’t have an office, nor did it have employees. In fact it wasn’t until 1994 that the first employee was taken on, prior to that the Institute of Biology undertook a lot of the administrative work, with support from volunteer members.
In a nutshell, it covers all of the following activities and more: • Advertising via a range of channels
The first employee didn’t last too long either, one year in fact. In 1995 BARQA appointed David Weller as Association Manager and moved into an office in St Ives.
• Conference planning and delivery
Two years later, in 1997, BARQA was incorporated as a Private Company Limited by Guarantee – that’s just 20 years ago. Around the same time the office moved to its present waterfront location in Ipswich. In 2012 BARQA became RQA, heralding a more global outlook and presence. David Weller retired in 2014 after almost 20 years as Association Manager and certainly the longest-serving employee to date. Of the present staff, Sarah joined RQA in 2003 and Tony joined in 2005 – both were employed as maternity cover. Gareth joined the team in 2007, followed by Danielle in 2008. Emma started in 2013 and Jane, Carl and Anthony joined in 2014. The newest recruits, Charley and Josh, started earlier this year. Each member of staff has a unique role and unique skills and experience. Anthony, for example, has been working in association management on and off for the past 26 years or more. Generally the RQA office is seen as an administrative function, however administration is a very small part of what the office actually does.
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RQA
• Bookings – accommodation, courses and events • Board matters • CRM development and implementation • Event material collation and production • Financial management • Liaising with collaborative partners, committees, members and venues
82500
FULL-TIME STAFF PLUS 2 PART-TIMERS
MEMBERS FROM 59 COUNTRIES
OVER 300
NEW MEMBERS JOIN EACH YEAR
• Marketing • Product development and delivery
56%
UNITED KINGDOM
• Quasar production and publication • Regional Forum coordination • Seminar coordination • Social media marketing and posting • Strategic development and operational planning • Website development and maintenance. All of this is on top of the corporate stuff, such as health and safety management, data protection, payroll, HR, etc. Certainly RQA in 2017 is vastly different from QAG in 1977 – 40 years of sustained development.
29%
EUROPE
ROW
15%
# OF FOLLOWERS
670
9,228
MAY 2014
MAY 2017
40 years of sustained development Members of the current office team (L-R): Jane Moulster, Tony Ward, Sarah Haig, Gareth Evans, Charley Barnard, Carl Lummis-Blaxell, Danielle Andrews, Anthony Wilkinson, Josh Dennington. (Not pictured Emma Michlbacher.)
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Regulatory Changes OVER THE LAST 40 YEARS
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RQA
animal health ith BARQA as was, Animal Health featured as a working party initiated in the mid 1990s, eventually becoming a committee some two years later. Initially, all members of both the Working Party and the Committee (AHC) were based in the UK. Members were all QA, a mix of sponsors, CROs and consultants. Meetings were almost always face to face, meaning a fair bit of travel. There was always a get together for dinner the night before, so the social aspect was deemed part and parcel of committee meetings. In those early days, minutes were sent by post!
What of industry – what changes? GLP and GMP remain the same, but the introduction of veterinary GCP in 1995 and the subsequent VICH GCP issued in 2000 have had a significant (and positive) impact on working practices. In today’s environment, it seems strange that in days gone by there were no ‘rules’ for veterinary clinical studies.
Since then the AHC membership has evolved. Over the last decade or more, committee members have included those acting as monitors or investigators, together with those working in pharmacovigilance and regulatory affairs. Meetings are now mostly by telephone, since committee members are spread across the globe (as far as Australia), but we do have an annual face to face meeting. Minutes are sent by email now too, far quicker and easier! We have strong links with the Animal Health Speciality Section of the SQA and this has led to some fruitful collaboration.
SVEN BUCKINGHAM
W
The industry remains robust, despite the numerous mergers and acquisitions that have occurred over recent years. Veterinary product R&D remains strong, with emerging markets such as aquaculture ensuring that life is never boring!
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GooD Laboratory Practice lthough Denmark and New Zealand had implemented GLP in 1972, it was not until the late 1970s when the FDA of the United States of America was finalising its law focused on pre-clinical studies (effective 1979) that the European pharmaceutical industry was galvanised into action. Multinational companies in Europe began appointing their GLP compliance managers with the daunting task of implementing the GLP standard. In the UK, a small group of these managers set up the Quality Assurance Group (QAG) in 1977, to consider how to implement this initiative brought on primarily by poor practices at companies such as Industrial Biotest. The day job of these managers was to establish GLP in their organisations, inspect its operation and train everyone in its purpose. Oh and of course to answer all the external inspection findings as well. No pressure then.
A
In the 1980s the USA Environmental Protection Agency followed with its regulations on pesticides and toxic substances, bringing non-clinical studies under the GLP umbrella. The OECD agreed its Principles of GLP in 1981 so its member countries also set off down the same road. This meant that member countries became party to the Mutual Acceptance of Data (MAD) agreement.
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RQA
The UK government set up the GLP Monitoring Authority, as required by OECD, and its routine inspections began. In 1986, it published the ‘blue books’ consisting of UK GLP Principles and guidance documents. Not to be outdone, the European Council weighed in with the Directive (87/18/EEC), telling the member states to comply with the OECD Principles – almost a law then. These were laborious times for the GLP community as GLP was bedding in. There was no internet (imagine…) so contact was by telephone, fax or posted letters. Almost all documents e.g. study plans, SOPs, reports, regulatory submissions (colossal piles of paper), were produced on a typewriter and photocopied for distribution. Audit reports were mostly hand-written. Obtaining copies of regulations, standards, guidelines and government inspection findings meant waiting for posted copies. Keeping up to date with important events necessitated networking by telephone and attending meetings and conferences. There was also the invaluable QAG Newsletter. Originally an occasional one or two-page bulletin, it was up to 12 pages long by 1987, which unsurprisingly came by snail mail too, courtesy of one of the multinational companies. In 1991 QAG was renamed BARQA (the British Association of Research Quality Assurance).
Throughout this and the following decades, experienced members of BARQA collaborated with GLP MA inspectors on the practical applications of GLP and with training. When BARQA set up its first training courses for quality assurance and study staff, there was always a presenter from the GLP MA inspectorate. Also, when formalising the expectations for specific areas e.g. computerised systems and data, field studies, the GLP MA acknowledged and called on the expertise within industry. There were significant outputs, including the major contribution made by BARQA experts to the Drug Information Association RED APPLE book (updated to RED APPLE II in 2008) as well as the OECD Consensus Workshops leading to guidance on computer systems and field studies, amongst others. And so, to the 1990s, when the OECD issued more GLP Consensus and Advisory Documents and finalised its revised Principles of GLP in 1998. From 1991, we had received European Directives on pesticides, cosmetics, biocides, detergents, veterinary products, etc. completing the non-clinical scope (so far). The OECD had incorporated the multi-site concept from Field Studies to all study types. This added complexity to the management of the pre-clinical pharma studies, but they soon got the hang of it. Eventually, via government inspections, increased understanding and improved systems, including those for quality control and assurance, it seemed that management finally accepted its responsibility for GLP, relieving the Quality Assurance personnel to focus on their allotted role of compliance assessment.
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By 1995 BARQA was renting office premises and had appointed a manager which gave the organisation a business focus and the Association really took off. On 1st April 1997, the OECD Principles of GLP had made it into UK law (Statutory Instrument 1997 No 654). Judgement Day had arrived. And hurrah, the 90s brought the internet, which gradually changed the way we operated. First it was the final reports and the SOPs. Soon most documentation, including audit reports, could be word-processed. Communication by email sped things up, provided your recipient was online of course. Also in the 90s the BARQA training courses expanded, it developed a Diploma course and later a Masters qualification. The QAG newsletter became BARQA’s quarterly Quasar magazine (1998). However, the face of the pharmaceutical industry was changing with mergers and acquisitions, consolidation of resources and disposal of less lucrative parts of large businesses. As studies became more scientifically complex, specialist subcontractors were increasingly used. In addition, large companies relied increasingly on subcontractors to carry out routine work while they focused on new compound research. Thus, the number of smaller organisations in the UK GLP programme increased and some very small businesses indeed, found they were subject to scrutiny and needed guidance on GLP as well as inspections from their sponsors. The 2000s brought new challenges for QA personnel. Some multinationals began to move operations to new locations, in some cases
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RQA
countries not yet party to OECD MAD and/or countries lacking a government monitoring programme. Consequently, sponsors sought clarification on the impact of this on their GLP compliance. The cost of compliance was under scrutiny so there was interest in improving audit efficiency by adopting the ISO 19011 auditing standard, which BARQA was promoting in its training courses. The need for a quality standard equivalent to GLP for clinical laboratories was identified resulting in the Good Clinical Laboratory Practice guideline developed by BARQA experts and the World Health Authority (published in 2002). In addition, BARQA first published ‘Guidelines for Quality in Non-Regulated Research’ in 2006.
libraries at your fingertips. Our own MHRA site is exemplary, while the RQA website continues to expand with webcasts and eLearning courses, as well as presentations, training course details, booklets and Quasar online. Finally, there has been a significant change in the balance of interests amongst RQA members, with the majority now from the GCP discipline and an ever-increasing international representation.
Most of the original EU countries had established GLP by 2000, but newer member states had to catch up. China, not yet an OECD member, issued a national GLP Law (2003). Early in the 2000s OECD issued guidance on multi-site studies and archives, while the GLP computing community picked up RED APPLE II (2008) and in 2011 transformed it into their PEACH.
In other ways, the QA role is more complicated with a wider scope of studies, more complex laboratory equipment, developments in technology, study elements that are not fully GLP compliant, negotiating differences in national laws and government advice, etc. However, as always, most challenges can be overcome by going back to first principles and engaging with the relevant parties. And as always, the wealth of knowledge of fellow RQA professionals remains available to all members – you just have to ask.
In 2012, in order to recognise that BARQA was reaching out to a larger community, it changed its name to the Research Quality Association (RQA). Meanwhile at home, documents and records were more often electronic and quickly transferrable, email allowed communication across the globe at any time. In the current decade, the internet has really taken over. Search engines have improved and the FDA, EPA and OECD sites have readily accessible, downloadable information – large
So today, thanks to improved technology, some tasks are easier. For example, locating information or communicating via the internet on computer, tablet or telephone is possible, anytime, anywhere. Training, meetings and conference calls are available without the need to travel.
JUDITH ELLIOTT AND THE RQA GLP COMMITTEE
MEDICAL DEVICEs edical device technology has developed in leaps and bounds over the last 40 years and in many ways the regulations have been running to keep up and find a workable mechanism which can regulate everything from nano-materials to complex multicomponent systems.
M
In Europe, the most notable change was arguably the harmonisation of standards which began in the 1990s with the introduction of the Medical Device, Active Implantable Medical Device and the In-Vitro Diagnostic Device directives. The directives were accompanied by the introduction of EN46000, a standard for medical device quality management systems. Initially, EN46000 added to the ISO9000 requirements but eventually ISO13485, Medical devices -- Quality management systems -- Requirements for regulatory purposes, was published as a standalone document.
Over the years, the standards and directives have been gradually modified, the emphasis always being patient safety and the efficacy of the devices. Over the last couple of years, much effort has been put into a major rewrite to convert the three directives into two regulations. The Medical Device Regulation, which includes Active Implantable Devices and the In-Vitro Diagnostic Regulation, the final publication of which is due in 2017. With a view to improving patient safety and device efficacy, the new regulations place much more emphasis on the need for good quality clinical evidence of safety and effectiveness, more comprehensive monitoring of the performance of devices in the field and the need for a risk-based approach as outlined in ISO14971, Risk Management for Medical Devices. COLETTE MCINTYRE
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“During my travels across the world, across many continents, I always hear the name ‘RQA’ as the society for quality assurance.” NIGEL DENT – CHAIRMAN 2002-2004
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20 RQA RQACELEBRATING 40 YEARS 1977-2017
www.therqa.com