June 2014
The TOPRA Newsletter – Keeping members in Touch
In this issue... With the sun shining – even in Glasgow – and knowing it’s a really busy time of year for all those involved in regulatory matters, I wanted to draw your attention to nominating in the Regulatory Affairs Awards. There are nine categories to choose from, and taking a moment to consider someone who has inspired, impressed or supported you in your career is a worthwhile and thoughtful way to spend some time. The regulatory arena is large, diverse and expanding. In this month’s issue you will read of TOPRA’s travels in Asia, the success of our new MSc graduates and the positive impact that social media can have on networking. Am I the only one who thinks the latter has largely passed them by, other than to watch what our teenagers are up to? Read on to find out how you can get involved! Ishbel MacDonald Regulatory Consultant, MacDonald Regulatory Ltd Co-Editor, InTouch
The Road to Singapore Jonathan Trethowan, TOPRA President
With professional and personal challenges occurring on a daily basis, it is important to extend our boundaries. This month has been especially notable for TOPRA in terms of new challenges and successful outcomes, in more ways than one! Like most parents, I spend time every week taxiing our children to various clubs and events. Now that summer has arrived the cricket season is well underway, and Friday evenings for me means cricket training for my son. We all know it’s good to push our comfort zone from time to time; last Friday mine was stretched as I had volunteered to run the weekly BBQ for the cricket club. Keeping up with demand was challenging but with terrific assistance from my daughter (and after the cricket, my son), the BBQ was a success. I am now up for the next challenge to push my comfort zone even further! Into Asia It is great to see the success of the recent Masterclasses held in Singapore and Hong Kong. Our group focused on taking expertise in European regulatory affairs to colleagues in global development, with an aim for TOPRA to be more active in this region in the future. I want to thank the team – Lynda Wight, Sue Harris and Bob Clay – whose hard work and enthusiasm was very much appreciated by our colleagues in this region.
Build-up to Brussels The 2014 Symposium Working Party has developed a strong programme for Brussels in October with the theme ‘Matching modern regulation with modern medicine – a patient-centred approach to regulatory affairs?’ This year’s Annual Symposium is held in conjunction with the Federal Agency for Medicines and Health Products (FAMHP), Belgium. Having reviewed the programme (now available at www.topra.org/sym2014), I’m really looking forward to the Symposium as a key event in the regulatory calendar. I along with a number of members of the TOPRA Board will be attending, and welcome the opportunity to speak directly with members about our organisation and any areas in which you may wish to see improvements. A ‘heads-up’ to everyone that the early bird discount is available up to 30 June (see below), so now is a great time to book your place! Many congratulations to the students who recently graduated from the University of Wales with their MSc in Regulatory Affairs. I am sure that your achievements
will enable you to develop your careers further and trust that as ambassadors for the MSc you will inspire colleagues to also take this path. I look forward to the opportunity to congratulate you in person at the TOPRA Awards on 9 December, where we take time out to celebrate excellence in our profession. This brings me to remind everyone that nominations for the Awards close on 30 June. Hopefully, through these monthly columns in InTouch, you all now know that I am passionate about people and their professional development. I believe it is vital for us all to recognise both the excellent work within and the commitment shown to our profession. This is something that is all too easy to overlook in our busy lives. I encourage everyone to make their nominations before the closing date – let’s make 2014 the most challenging year yet for the Judges.
book now to receive your early booking discount
Booking is now open for the 11th TOPRA Annual Symposium 2014 – the key event in the European calendar for professionals working in regulatory affairs. Book your ticket before 30 June and save £125! Visit www.topra.org/sym2014ebf for more information.
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
regulatory affairs awards, 9 December 2014, royal college of surgeons, london
register now to make your nomination by 30 june Craig McCarthy, Chair of the Working Party for the Awards for Regulatory Excellence, explains why it is so important to celebrate exceptional work in our profession When I was TOPRA President a few years back I championed the idea to hold a Regulatory Affairs Awards ceremony, along with Alan Hunter as Vice President. Of course, like all new ideas this has taken a lot of hard work to get off the ground and the Awards are growing successfully year on year, particularly as regulatory professionals, regulatory teams and regulatory support companies embrace and support the concept of ‘Excellence in Regulatory Affairs’. This year we have introduced two new Awards categories to broaden the number of nominees who can be awarded, and who represent the quality and breadth of our professional activity. Recognise your colleagues I’m sure you see excellent contributions from regulatory professionals in your daily work.
INNOVATION
As a manager in a department, a head of a regulatory group or a team leader, you should be looking to nominate those who you feel have proven to be great ambassadors for our profession. Nominating is a key part of the process, and I am sure your nominee will be delighted that you have recognised their hard work. It’s great to see the winners’ elation when they receive their Awards. I am glad to be a cheerleader for these prestigious Awards on behalf of TOPRA, the leading international organisation for our profession and rightful supporter of the Regulatory Affairs Awards. Thank you to our supporters I would like to thank those companies that have supported the Awards, and of course our prestigious judges who through their hard work and expertise ensure
CHAMPION
2014
an independent outcome to the proceedings. Onwards and upwards So what is our vision for the future? Of course it is to encourage the growth of the event in both numbers and nominations, and to make the Awards ceremony a truly unmissable celebration of regulatory excellence. We also want to make it an event for networking – bringing friends and colleagues together for a fun evening a little different from our day-to-day busy professional activities. I look forward to meeting many of you at this year’s event – due to be held at the Royal College of Surgeons in London on 9 December – and celebrating excellence in our profession. Good luck to all those nominated, you are all winners in my eyes.
NOMINATE TODAY
Visit the Awards website to choose your category: www.regulatoryaffairsawards.org.
Fellowship update
Following on from last month’s InTouch covering the significance of TOPRA Fellowship for our organisation, we are pleased to welcome Dr Rhona Banks as a newly elected TOPRA Fellow
Rhona Banks, RA-ELECT
Rhona is very highly regarded in the industry due to her in-depth knowledge and expertise in the development and registration of veterinary immunological (and other biological) medicinal products. Having been a regulator at the Veterinary Medicines Directorate (VMD), worked in industry and as an independent consultant, Rhona has observed the changing EU regulatory landscape from a number of different perspectives. Serving on the Veterinary Symposium Working Party for the past four years, Rhona has regularly presented on topics of which she is an acknowleged expert. Congratulations, Rhona!
TOPRA InTouch Newsletter – June 2014
TOPRA InTouch Newsletter – June 2014
masterclass: european regulatory affairs, may 2014, hong kong and singapore
memorable moments:
taking eu regulatory to asia
TOPRA undertook its first foray into Asia in May with visits to Singapore and Hong Kong, organised with the assistance of the University of Hertfordshire as our MSc accrediting partner In each country TOPRA organised a Masterclass in European regulatory affairs, which looked at how legislation and guidelines are developed, explained the major systems and players and examined current ‘hot’ issues such as access to medicines. Our expert speakers were Sue Harris (Unit Manager, Product Lifecycle Assessment Team 5, MHRA) and Bob Clay (Managing Director, Highbury Regulatory Science and TOPRA Board Director). In Singapore the training was organised in partnership with the
Pharmaceutical Society of Singapore (PSS), who welcomed the TOPRA team with a barbeque at their headquarters with delegates and representatives of the Health Science Authority (HSA). The two-day Masterclass included case studies and a discussion of how TOPRA can support regulatory professionals and the importance of Continuing Professional Development (CPD). In Hong Kong, the Masterclass was held in the headquarters of the Drug Office of the Department of Health. For this one-day event there were over 130 registrations and the presentations were
followed by lively discussion sessions. Our partners, the Hong Kong Association of the Pharmaceutical Industry (HKAPI) and Hong Kong University, hosted a dinner for the TOPRA team and senior Drug Office officials. We will be looking at how TOPRA can continue to be active in this region, taking our expertise in European regulatory affairs to our colleagues in global development. If you have any ideas, or want to be involved in future training and other activities, please get in touch with lynda@topra.org.
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2 1
The TOPRA team including Bob Clay
(third left), Lynda Wight (fourth left) and Sue Harris (fifth left); along with Dr Matt Traynor (Associate Dean of the University of Hertfordshire) with representatives of the Drug Office, Department of Health, Hong Kong, HKAPI (the trade association) and Hong Kong University. 2 Frank Chan Ling Fung (Chief
Pharmacist, Department of Health) has a question for our expert speakers.
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3 Bob Clay presents to delegates at
the headquarters of the Drug Office in Hong Kong. 4 Students wave their certificates of
attendance, having completed the intensive two-day programme in Singapore.
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5 A delegate from Singapore presents
a case study to the group.
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ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
TOPRA InTouch Newsletter – June 2014
MEMBERSHIP NEWS
Join the social network
InTouch Editors:
Head of Membership Duncan Judd explains the benefits of connecting with your peers through social media As a member of TOPRA you are part of a wider regulatory community with excellent opportunities to network through traditional ways, such as at the Annual Symposium. While face-to-face meetings are invaluable, social media is becoming integral to communication in everyday life. In response to this trend, our LinkedIn groups, Twitter feed and Facebook page allow you to engage in discussion that is relevant to your professional interests, particularly when you don’t have the opportunity to speak with your fellow regulatory professionals in person.
With over 10,000 TOPRA LinkedIn members across three main groups (pharmaceutical, medical devices and veterinary), you can instantly discuss the latest issues online. If you prefer regular short news updates about TOPRA activities or the wider regulatory community, then head to our Twitter feed (@topranews) and join our 1,000 followers which include the European Medicines Agency (EMA). For more informal interactions, visit and ‘like’ the TOPRA Facebook page. Here we concentrate on the social side of our networking activities,
such as the networking reception and dinner at the Annual Symposium. The Facebook page includes photographs taken at those events – why not have a look and tag yourself? Whether you are an active participant or just an ‘observer’, there is no doubt social media has made networking and interacting with colleagues and friends much easier. Sign up to TOPRA’s social media groups today and start making connections with fellow regulatory professionals – links are accessible via the TOPRA homepage (www.topra.org). Join the debate!
Congratulations to our graduates!
(L-R) Anne Lenihan, Dipti Patel, Claire Roche, Jeff Adamson and Siwan Thomas graduated with an MSc in Regulatory Affairs from the University of Wales on 1 May, in a ceremony held at the Millenium Centre in Cardiff. Congratulations on your success!
NEW TOPRA MEMBERS
Greer Deal, Ishbel MacDonald, Graeme Ladds and Jenine Willis
Assistant Editor: Rachel Cook
How to contact InTouch InTouch welcomes contributions from TOPRA members. If you would like to contribute to the newsletter, or find out about deadlines, please contact Rachel Cook (rachel@topra.org). Please address any articles and correspondence to: intouch@topra.org or submit your contribution via www.topra.org/intouch Views expressed in InTouch are those of the contributors and not necessarily those of the editors or TOPRA. While every effort is made to ensure information is accurate, conditions may change and readers are advised to consult current official texts and/or to seek appropriate professional advice before taking any regulatory action. © 2014 The Organisation for Professionals in Regulatory Affairs TOPRA Bellerive House 3 Muirfield Crescent London E14 9SZ Tel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 E-mail: topra@topra.org InTouch is free to TOPRA members. Annual membership of TOPRA is £185. TOPRA members can read or download InTouch online at www.topra.org
TOPRA welcomes the following new members who joined recently Mrs Julie Calonge, Regulatory Affairs Consultant, Nanterre, France Mrs Valerie Ciaravino, Senior Manager Regulatory Intelligence, Celgene, Boudry, Switzerland* Mrs Susan Dairy, Regulatory Specialist, ICON Clinical Research, Marlow, UK Miss Mare de Graff, Utrecht, the Netherlands
Miss Regina Eguiluz, Senior Regulatory Affairs Specialist, Cambridge, UK Mr Brendan Glynn, Medical Writer, Co. Sligo, Ireland Mrs Jeanne-Marie Jacquet, Director, GlaxoSmithKline Biologicals, Wavre, Belgium Mrs Caroline Kirwan, Regulatory Affairs Specialist, HeartSine Technologies Ltd, Belfast, Ireland
Mrs Nadege Le Roux, Director Regulatory Intelligence, Celgene, Boudry, Switzerland* Mrs Lone Ekstrom Ragn, Senior Consultant, Ragn Regulatory Consulting, Hareskovby, Denmark Mr Chaminda Salgado, Head of CMC Bioassay & Genomics, NDA Analytics, Huntingdon, UK* Mr Raymond Tamba Sombay, London, UK (Student)
Ms Pallavi Trivedi, Assistant Manager, Miyapur, India* Mr Matthew Trivett, Novella Clinical, Stevenage, UK Dr Ngoc-Tri Vo, Novella Clinical, Stevenage, UK Miss Sheila Williams, Colonis Pharma, Senior Regulatory Officer, Tunbridge Wells, UK* Mr Austin Witter, Regulatory Consultant, AGW Regulatory Ltd, Deal, UK*
TOPRA is the registered trademark of the The Organisation for Professionals in Regulatory Affairs Ltd, registered community trademark number 003182961. The TOPRA logo is covered by the Community Design Registration Numbers EU Des Reg nos. 000055553-0001 and 0002.
*Registered Member
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION