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May 2014

The TOPRA Newsletter – Keeping members in Touch

In this issue... It is great to see the growing interest in many of our TOPRA In countries for developing a career in regulatory affairs. The student workshop held last month in Austria (see page 2), reinforces how students can get a head start in focusing their career with guidance from experienced professionals. Of course, TOPRA is able to support regulatory professionals at both ends of the career scale. TOPRA Fellowship recognises the many years of dedication that can be achieved in our profession – could you join them? Finally, it’s time to be thinking about the learning opportunities that might benefit your career. With the expansion of TOPRA’s medical devices training (see page 4), now is a great time to explore your options! Graeme Ladds Director, PharSafer Co-Editor, InTouch

From beginners to Fellows Jonathan Trethowan, TOPRA President

With membership categories to suit all stages of a regulatory career, TOPRA is constantly evolving to ensure that membership fulfils the requirements of professionals in a changing regulatory environment April was a great month for our organisation. In this month’s InTouch I want to reflect on these successes and look toward some exciting developments that I am confident will drive continuous improvement for TOPRA, while moving us towards our collective vision of enabling and promoting excellence in the healthcare regulatory profession. The TOPRA In Austria working party held a pilot student workshop day at the University of Vienna (see page 2). This proved to be a successful event attended by more than 25 students interested in a career in regulatory affairs. Due to the positive feedback we now have the opportunity to extend this model to other TOPRA In groups. This is particularly exciting for me, as I am passionate about addressing the need to attract new talent into regulatory affairs to ensure we secure a bright future for our profession. The Spring Introductory Course was a sell-out event with attendees representing a cross-section of members’ organisations. This is very encouraging, as it reinforces the reputation that our introductory courses have

of setting the standard for professional training at the start of a regulatory career. It is also reassuring to know there is a rich talent pool to feed the ongoing need for excellent professionals. I am sure the delegates who attended the course will have thoroughly enjoyed the experience, and formed connections to support them throughout their professional lives. We all rely on our networks for support, and within TOPRA we are privileged to have a number of defined networks. Previously I spoke about developing a Young Regulatory Professionals SPIN Group. I’m delighted that Toby Butcher (TRAC Services) and Duncan Judd (Head of Membership, TOPRA) are working hard to ensure that this new network becomes a reality. One idea for this group is to establish a process by which TOPRA Fellows provide mentoring assistance. Clearly this will be extremely valuable for the young professionals as well as rewarding for the Fellows. There are numerous possibilities for a group like this one, so if you are interested in getting involved

please contact Duncan ( In addition, a TOPRA Fellows’ Dinner will take place at Villandry in Waterloo Place, London on 11 June. The evening will hear from Dr Ian Hudson who will introduce the MHRA’s plan for early access to medicine. I am sure this topic will lead to much debate, and I urge all Fellows to take the opportunity to attend. On that note, I encourage everyone eligible to put themselves forward to join this prestigious group within our organisation – you too can have the opportunity to shape the direction of TOPRA for all members (see page 3). In this issue I have touched briefly on a very small number of areas where TOPRA is able to support and add value to our professional lives. Thinking about these and everything else TOPRA has to offer, I hope you agree that the organisation is very much here to serve us throughout our careers.

Improving medicines worldwide QUAMED (Quality Medicines for All) is the project that aims to improve the quality of medicines distributed in developing countries by establishing a network of non-profit organisations focused on this goal. Due to QUAMED’s increased activities, the UK government are calling for Quality Assurance experts to help assist in those countries in need of resource. If this is something you may be interested in applying for, please contact


Student workshop: careers in regulatory affairs, 9 april, austria

students get to grips with regulatory affairs

TOPRA recently held a successful student workshop at the University of Vienna, in conjunction with AFÖP (Akademischer Fachverein Österreichischer Pharmazeutinnen)

Led by Patrick Gassenbauer (AFÖP) and Elke Hofer-Litzlbauer (Baxter), the workshop provided more than 25 enthusiastic students with an overview of regulatory affairs and the many possible routes of entry into the profession. With knowledgeable speakers guiding the students, the day proved to be a great example of effective teamwork and covered a broad range of topics, including regulation processes in the EU and Austria.

Patrick Gassenbauer (far left) and Elke Hofer-Litzlbauer (third left) led the student workshop, held at the University of Vienna’s Faculty of Pharmacy.

topra in sweden, 8 april, uppsala

rewarding membership Christer Backman received his Honorary Life Membership at a recent TOPRA In Sweden networking and regulatory update meeting at the Medical Products Agency (MPA)

Margareth Jorvid, TOPRA In Sweden WP Chair, presents Christer Backman with his Honorary Life membership certificate.

TOPRA InTouch Newsletter – May 2014

Christer was presented with the Honorary Life membership certificate for his work in regulatory affairs, and for the support he has given to TOPRA throughout many years. Beginning his career as a Business and Tax lawyer, Christer joined the MPA in 1994. As a senior expert, he is EU Coordinator within Scientific and Regulatory Strategies at the MPA. The networking meeting continued with a welcome and introduction by Margareta Busk, Director of Regulatory Affairs at NDA. Around 40 participants also gathered to hear the latest regulatory news on pharmaceuticals, presented by Christer Backman with a focus on the new Clinical Trials Regulation. Helena Dzojic addressed the European Parliament legislative resolution of 2 April

2014 on the EU Commission as proposed Regulation for Medical Devices, adding some new aspects and proposals for consideration. The Innovation Office and how it can support companies via MPA scientific advice and other activities was also presented by Brita Sjöström, MPA. Margareth Jorvid, Methra Uppsala/LSM group, rounded up the session with an update on TOPRA’s activities, highlighting how belonging to a professional body is a real benefit for members who want to take advantage of the increased knowledge and networking that an organisation like TOPRA can bring. To find out more about your local TOPRA In group, please visit

TOPRA InTouch Newsletter – May 2014

TOPRA welcomes two new fellows Oscar Koomen and Rosalind Cox have recently been elected Fellows of TOPRA, recognising their commitment and service to the regulatory affairs profession Both Oscar and Rosalind have a wealth of experience, and throughout their careers have helped to influence and develop the profession in a proactive way. Oscar was the Founding Member of the European Regulatory Affairs Leadership Team of AstraZeneca R&D, ensuring successful implementation of European regulatory strategies. He has also managed the AZ megabrands Symbicort and Seroquel from a European regulatory perspective. Since 2005, Oscar has been Portfolio Leader of European Regulatory Affairs at AZ R&D. Rosalind has worked in European and international regulatory affairs in the

pharmaceutical industry and consultancy for over 27 years – holding senior positions in multi-national companies. She has led large groups of more than 65 regulatory professionals in various EU markets, the US and Singapore. For the past three years, Rosalind has been a Scientific Adviser and Principal Consultant for NDA Group. Fellowship is awarded to TOPRA members who have at least 10 years’ experience in regulatory affairs, and who have been recognised as making a significant contribution throughout their career. The award is also intended to reinforce the way that senior regulatory professionals can utilise their experience

Oscar Koomen, AstraZeneca

Rosalind Cox, NDA Group

and knowledge in order to influence and guide their colleagues, and the profession as a whole. Following a nomination from at least two TOPRA members and endorsement by the TOPRA Board, Fellows are able to use the designation FTOPRA and receive all the benefits of membership.

Do you qualify for TOPRA Fellowship? You could join Oscar and Rosalind as a TOPRA Fellow – the full criteria and proposal form are available on the TOPRA website. Please visit categories



Do you know a person, team or organisation who deserves to be recognised for their outstanding work in healthcare regulatory affairs? With nine categories available there is sure to be one that truly recognises the attributes of your nominee. Visit the Awards website to choose your category:

This year’s glittering ceremony will be held on 9 December 2014 at the prestigious Royal College of Surgeons at Lincoln’s Inn Fields in London. Guests will have the opportunity to network among the unique exhibits in the College’s Hunterian Museum. Join us to support your colleagues and fellow regulatory professionals in an evening that is guaranteed to celebrate excellence.


We are pleased to announce that F. Hoffman-La Roche will be supporting the 2014 ceremony as an Awards Champion. The company will join Samarind, which is supporting the Innovation Category again this year. Without this valuable support the celebration could not take place – if you would like to get involved contact for more information.


TOPRA InTouch Newsletter – May 2014


Share your expertise

InTouch Editors

Head of Membership Duncan Judd reviews extending our member discussion groups Our Special Interest Networks (SPINs) are a great way for members to share their expertise. By debating the latest developments in regulation and progress in a particular area, many members have commented on the benefit that such discussions can have both in their research areas and in their own professional development. When applying for TOPRA membership we request that members inform us not only of the SPINs they might be interested in joining (these

include biotechnology, medical devices and clinical trials, among others), but also a range of general areas of interest. This means we can ensure you are kept updated about the topics which are most relevant to your career. It is these more general areas of interest that I would like to develop going forward. It is evident from the feedback we have received that discussion groups with a wider focus would be beneficial, allowing members to share their professional

interests in a more tailored environment. In addition to the current SPIN groups, these extended areas will include advanced therapies, document management, borderline products and orphan drugs. In the next few months I will be using these data to establish how we can further utilise our members’ expertise in this way, with a focus on career development. To find out more about joining a SPIN group, please visit

Do you specialise in medical devices? TOPRA’s medical devices coverage is branching out TOPRA has been developing various courses, conferences and other services in direct response to the growing importance of medical devices regulatory affairs. While the Medical Devices Symposium is already a wellestablished conference in its own right – this year is the 9th – we have also introduced the Basics of Medical Devices, as well as the new Medical Devices Introductory Course. Learning If you are just exploring the area or are taking your first steps into

the specialty, the Basics Course is the one for you. However, if you are looking to establish yourself in the medical devices sector, you should consider taking the 3-day residential Introductory Course, which takes place this year on 25–27 June in London. Our MSc in Medical Technology Regulatory Affairs, run with Cranfield University, can also be taken as separate Masterclasses. These courses are aimed at senior regulatory professionals. Need to hear the latest issues in the area? You should attend our

Annual Symposium, which will be held in Brussels, Belgium on 14–15 October. Networking Our popular and influential Medical Devices Steering Committee is always looking for new members. Alternatively, if you wish to network with other professionals working in this area, our Medical Devices LinkedIn group recently welcomed its thousandth member! For more information visit


TOPRA welcomes the following new members who joined recently Ms Aine Cunningham, Head of Regulatory Affairs, Generic Specialty Pharma, Stamullen, Ireland* Dr John Lang, Managing Director, Medwise International Consultancy, York, UK Dr Sophie Ramusat, RA Associate, Allergan Ltd, Marlow, UK* Mr Alain Meuwly, Cournillens, Switzerland (Student) Mr Aaron Barzey, Global Labelling Lead, London, UK* Ms Mariam Mnatsakanyan, Geneva, Switzerland (Student) Dr Fernanda Mendes, Head of Regulatory Affairs and Quality Assurance, Odivelas, Portugal*

Ms Kimberley Harden, Regulatory Affairs Analyst, Allergan Ltd, Marlow, UK* Ms Elena Airikainen, France (Student) Mrs Lucy Pitcher, Global Regulatory Affairs Associate III, PRA International, Beverley, UK* Mr Jakub Weber, Havlickuv Brod, Czech Republic (Student) Mr Fahad Alhadyan, Scientific Office Manager & QPPV, Eisai Co Ltd - Saudi Arabia, Saudi Arabia Ms Andrea Masciale, VP, Global Regulatory Affairs, Janssen Pharmaceuticals (J&J), Titusville, USA*

Dr Susana de Azevedo Wasch, Head of Global Regulatory Affairs, Geistlich Pharma AG, Wolhusen, Switzerland Mr Mohammad Huzefa Baig, Baig Pharma Consultants, Drug Safety Advisor, Slough, UK Ms Katherine Kelly, Regulatory Affairs Officer, Helsinn Birex Pharmaceuticals Ltd, Mulhuddart, Ireland* Miss Camilla Elizabeth Smallbone, Shepperton, UK (Student) Mr Arne Vladimir, Blackman, London, UK (Student) Miss Sharmila Andy, Perak, Malaysia (Student) Mr Viktor Kinlan, Vienna, Austria (Student)

Mr Julian Nancarrow, Regulatory Director, Quanta Fluid Solutions, Northfield, UK* Mr Muhammad Faisal Iqbal, Norbrook Laboratories, Cloughoge, UK* Severine Bugnand, Category Manager, Global Regulatory Affairs, Novartis, France* Mrs Virginie Collas-Aubert, Regulatory Affairs Director, Vertex Pharmaceuticals (France), Paris, France* Ms Celia Susana Domingues Alves, Binningen, Switzerland* Ms Tania Mateus, Regulatory Affairs Officer, Wockhardt UK Ltd, Wrexham, UK Mrs Florane Courbard, Regulatory Affairs Executive, Forest Laboratories, London, UK*

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 ( Please address any articles and correspondence to: or submit your contribution via 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: InTouch is free to TOPRA members. Annual membership of TOPRA is £185. TOPRA members can read or download InTouch online at

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


TOPRA InTouch May 2014  

TOPRA Newsletter

TOPRA InTouch May 2014  

TOPRA Newsletter