Welcome to our new Board membersAt the Annual Review Meeting on 27 November 2013, TOPRA announced the new Board of Directors appointed after a well-supported election process.

Four new Directors, including Bob Clay (recently VP Regulatory Affairs, AstraZeneca – now independent), Thomas Kuhler (VP, Novo Nordisk), Carlos Langezaal (Director Global Regulatory Afairs, Eisai) and Angela Stokes (Director Global Regulatory Affairs - Oncology, Eisai) have taken up their roles this month.

Speaking at the Annual Meeting, the new President, Jonathan Trethowan, looked forward to a year in which opportunities will increase for members to develop their professional competency through enhanced virtual training offerings, peer-to-peer networks and increased collaboration between TOPRA and partner organisations.

I first became interested in regulatory affairs when attending a postgraduate careers event to highlight career opportunities for PhD students who did not plan to follow an academic path. After completing my PhD at the University of London it took just over 12 months to secure my first role in regulatory affairs, time that I spent working in the bioproducts development laboratories at Glaxo Wellcome.

In January 1997 I started my first regulatory role with a small pharmaceutical company called ML Laboratories. In this position I was responsible for a number of products that were in varying stages of development and my first task was to convert an IND into a CTX package – I had very little idea of what these were at the time (if only I had had the option of a TOPRA Student Membership).

Just over four years later and following my daughter’s birth, my wife Sarah and I decided to return to Cornwall to raise our family where I had grown up (the roots

of my surname are no longer a secret).

At this point Sarah and I established TRAC Services, an independent regulatory consultancy, with Sarah covering the business side. I supported varying projects, both remotely and onsite when required, and in four years we had developed sufficient business to grow the company.

With very little regulatory experience available on our doorstep we decided to train life science graduates and develop these into regulatory professionals. This process has been very successful, and 12 years later we have grown our team to 20.

I was delighted in 2010 to win the Inspiration Award at the inaugural TOPRA Awards. Many of you will have worked with my colleagues as they regularly volunteer in many roles including the Professionalism Committee, CRED courses, and within a number of the SPIN groups.

Growing and developing the team at TRAC has resulted in my passion for supporting professionals at the beginning of their regulatory career. One idea that was shared with me at the 2012 Symposium in Dublin was the formation of a Young Regulatory Professionals Group.

This is an excellent idea, and could be set up as a SPIN Group supported by our Fellows network in order to facilitate discussion among this section of our membership. I would be delighted to hear from any members interested in forming this group so we can make this a reality.

Wishing everyone a happy, healthy and successful 2014.

Taking the lead in 2014Jonathan trethowan, toPra PresidentThe 1 January 2014 represented our organisation’s 10th anniversary, and I am delighted to be representing TOPRA as President at the start of our second decade.

in this issue...exciting changes are underway in 2014; toPra is entering a new decade with a new President and toPra Board who have many refreshing ideas.i think i’m safe to say that 2014 is going to be a year of significant change not only for toPra and its members, but also across the industry as a whole.the toPra branding project and innovative website and database restructure is imminent. with all these new initiatives, we welcome your feedback so that we can continue to improve the services we provide for you, the toPra members.so it’s a ‘happy 10th Birthday’ to toPra and a ‘happy new Year’ to you all!

Greer DealDirector, Global Regulatory ServicesCo-Editor, InTouch

ThE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCh

January 2014

enaBLinG and ProMotinG eXCeLLenCe in the heaLthCare reGULatorY ProFession

Angela Stokes

Carlos Langezaal

Bob Clay

Thomas Kuhler

Mhra staKehoLder enGaGeMent

A new approach

Take a TOPRA masterclassNEW decadeNEW look

As part of TOPRA’s developing educational programme for senior regulatory professionals, members can take three-day short courses covering a range of regulatory topics in depth.

In the first half of this year there will be Masterclasses on the US Regulatory Environment (4–6 February); Data requirements for abridged applications (2–4 April); Management of regulatory affairs (29 April –1 May); and Product development, maintenance and commercialisation (3–5 June).

These short courses are an ideal way for experienced regulatory professionals to deepen their knowledge further and update themselves on the latest developments. They can also be taken as part of the TOPRA MSc Regulatory Affairs programme, leading to a well-respected qualification.

For a full programme of Masterclasses related to pharmaceuticals and medical devices, go to https://www.topra.org/conferences-courses.

TOPRA members Jenny Lamport and Peter Blakeney attended the first MHRA Stakeholder Engagement Meeting (StEM), in London on 25 October 2013.This new type of engagement was designed to be more inclusive and less repetitive than the previous Consultative Committee format across the GxPs (GLP, GCP and GPvP). The meeting format is in two parts – the first for all GxPs, the second for the individual GxPs.

Part 1: RBIThe Risk-Based Inspection (RBI) update was presented in terms of how data were collected from different sources and inspection findings, and then entered into a single database folder.

It was then categorised, from which the necessary metrics, trends, etc could be drawn so as to assess the relevant risks and how the inspection schedules can be applied.

An MhRA project regarding communications

and perceptions has been initiated with the aim of assessing how stakeholders perceive the MhRA, and how a collaborative approach can be applied to improve and enhance the service – a type of SWOT analysis.

Feedback and comments from stakeholders are encouraged and welcomed so as to make the analysis representative.

Part 2: RQAThe Research Quality Assurance (RQA) bench-marking survey was presented in relation to feedback on pharmacovigilance inspections from January 2012 to March 2013, in relation to the QA aspects on the PSMF. The overall outcome was favourable but there were some mixed results.

Issues regarding off-label use and what constitutes a

valid case, the reporting requirements and how these are being addressed by both MhRA and EU were presented. This continues to cause confusion which will be resolved through clarification of PV regulatory requirements.

The MhRA is working on a new aspect of PV inspections relating to the introduction of GPvP service provider inspections; these will be similar to MAh PV inspections but will concentrate on the systems rather than the specifics.

A pilot scheme will be run and the MhRA will be looking for volunteer service provider companies to participate.

The next RBI questionnaire is being drafted and adapted to take account of feedback received from the previous

questionnaire and updated in line with the new PV legislative requirements.

The MhRA is expected to issue the questionnaire soon with a deadline for reply in March.

A new edition of the Purple Guide is being worked on but no publication date is available yet.

Full minutes from the MhRA are available on https://www.topra.org/mhra-stakeholder-engagement-meeting-25-october-2013 with the usual confidentiality provisos being applied.

If you have any issues that you would like Jenny or Peter, as TOPRA representatives, to raise at these stakeholder events please email topra@topra.org.

You may have noticed our new logo on the website and in Regulatory Rapporteur. This is all part of TOPRA’s new branding project, designed especially to bring us into our second decade as an active and modern organisation. We haven’t stopped there!

The branding of all TOPRA activities has been refreshed to reflect career progression for members. Keep an eye out for our rebranded materials, and if you have any comments or suggestions let us know by contacting jenine@topra.org.

Co n t i n U i n G P ro F e ssi o n a L d e V e Lo PM e n t

TOPRA InTouch Newsletter – January 2014

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TEN YEARS OF TOPRA as toPra celebrates its 10th birthday, we have selected a few of the many images in our files that reflect our activities and highpoints over the years. For more photos, go to our Facebook pages. Please send us any memorable images you have of toPra and we will publish some of them in upcoming editions.

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA InTouch Newsletter – January 2014

1 at the official toPra launch on 21 april 2004, dr daniel Brasseur speaks via live satellite video link from Brussels to enthusiastic members gathered at the Four seasons hotel, London.

2 & 3 Based initially at the heron Quays office, toPra headquarters moved to Bellerive house in 2009.

4 Justina Molzon from the Fda speaks at the first toPra north america Conference in washington dC in 2006.

5 2013 saw the launch of the first Medical devices introductory Course, joining the successful and long-established spring and autumn introductory Courses.

6 delegates at the toPra annual symposium have sampled the sights of multiple european cities in 10 years, including a boat trip in amsterdam in 2006.

7 in october 2012 toPra held its largest annual symposium at University College dublin, in partnership with the irish Medicines Board.

8 toPra staff and Board members get involved in a team-building exercise in 2008 as part of a strategy planning day.

9 the awards for regulatory excellence, now in its fifth year, has seen many worthy winners recognised for their commitment to the regulatory affairs profession.

10 students collect their Postgraduate diploma from dr aginus Kalis at the 2006 symposium in amsterdam. over 60 students have now achieved the toPra Msc in regulatory affairs.

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As a new year starts we aim to showcase some of the developments that we have been working on for 2014.

With the introduction of the new database and website in the next few months, members will see a system that will help them interact with other members, access more benefits and utilise the website as a ‘one stop shop’ for information on all TOPRA

events, meetings, dates, agendas and much more.

It will increase the function of the already popular SPIN groups’ e-communications, and will ensure that we invest time into those areas that members feel they benefit from most.

With ever-growing membership numbers, we will continue to work on bringing members together

in an environment which facilitates neutral and independent discussion.

I look forward to meeting many more of you in the year ahead, and to update you on our new membership developments.

If you would like to know more about how to maximise the benefit of your membership or how to volunteer, please email me at duncan@topra.org.

Looking to the future In this month’s column, Head of Membership Duncan Judd explains the new features that members can experience in 2014.

MeMBershiP news

enaBLinG and ProMotinG eXCeLLenCe in the heaLthCare reGULatorY ProFession

TOPRA InTouch Newsletter – January 2014

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 no. 000055553-0001 and 0002.

NEWTOPRAMEMBERSMrs Veronique Janet, RA VP, Stallergenes SA, Antony, France*Ms Audrey Bru, Regulatory Affairs Manager, Lallemand SAS, Blagnac, France*Dr Rita Bibbo, Regulatory Affairs Officer, AbbVie Ltd, Maidenhead, UK*Mr Adan Hawley, Director, Tadworth, UK*Mrs Francesca Di Renzo, Regulatory Affairs Consultant, Di Renzo Regulatory Affairs, Rome, Italy*Ms Tin Choi Lam-Schlabbach, Regulatory Affairs Associate, Xendo Deutschland Gmbh, Berlin, Germany (Student)Miss Beverley Woodward, Regulatory Affairs Specialist, Abingdon, UK Ms Casilda Luck-Barnes, Celgene, Warren, USAMs Ameera Mehta, North harrow, UK*Dr George Ormandy, Director, Ipsen Biopharm Limited, Slough, UK Dr Francisco Noronha, Portugal*Mrs Nicole Foster, Regulatory Affairs Manager, Abbott healthcare Products Ltd, Vanwall Road, UK Ms Elena Fasniuc, Universitatea Stefan cel Mare Suceava, Botosani, Romania (Student)Mr Pedro Reis, Faculdade de Farmacia da Universidade de Lisboa, Portugal (Student)Mr Ricardo Deus, Portugal (Student)

Miss Ana Catarina da Silva, Duarte, Caldas da rainha, Portugal (Student)Mr David Tice, Leek, UK*Mr Jay Gandecha, Regulatory Affairs Executive, Morningside healthcare Ltd, Leicester, UK*Miss Fiona McNeill, Quality Assurance Manager, Contamac Ltd, Saffron Walden, UK Mr Martin Lanigan, Tullaroan, Ireland (Student)Miss Sara Soares, Ponte de Lima, Portugal (Student)Dr Ian Thomas, Kidlington, UK Mr Amar Nawaz, Bordesley Green, UK*Miss Suzanne Wilson, Canterbury, UK*Mrs Isabelle Clamou, Regulatory Affairs Director-EU Policy, Amgen, Brussels, BelgiumMr Marcio Silva, Regulatory Affairs Manager, GlaxoSmithKline Brasil Ltda, Rio de Janeiro/RJ, Brazil*Dr Nora Chew, Senior Manager, USA*Mrs Joanne Elworthy, Pharmacist, Bridgend, UK Ms Loredana Rizzo, Isleworth, UK*Mr Keith Sumerhayes, Director Clinical, MDCRQ Solutions, Aberdare, UK*Dr Bernard Delaey, Director Regulatory Affairs, Ablynx NV, Zwijnaarde, Belgium*Mr Jagraj Sangha, Regulatory Operations Associate 1, Gilead Sciences Intl, Cambridge, UKDr Claudia Hey, Director Global Regulatory, Merck KGaA, Dramstadt, Germany*

Mr Joerg Jenewein, Director European Public Affairs, Novartis Pharma, Brussels, Belgium*Miss Jacqui Hunt, Associate Regulatory Affairs Manager, Janssen-Cilag Ltd, high Wycombe, UKMr Manon van Egmond, Ipsen Farmaceutica BV, LS hoofddorp, The Netherlands Ms Queenia Lee, Apotex Inc, Toronto, CanadaMiss Boatemaa Ofori-Frimpong, Glasgow, UK (Student)Mr Ioannis Tataridis, Manchester, UK (Student)Miss Esra Akcay, Regulatory Assurance Manager, Interport Ltd, Croydon, UK*Mr Ladislav Paul Kochman, Regulatory Manager, SwitzerlandMrs Safana Sayeed, Regulatory Affairs Manager, Dr Reddy’s Laboratories (UK), Cambridge, UKDr Liz King, Associate Director of operations, Pharmalink Consulting, Maidenhead, UK*Miss Oluwaseun Sogbesan, Altrincham, UK Mrs Christina McCarthy, Associate Director Regulatory Affairs, Dyax Corp, Burlington, USA*Ms Stephanie Capo Chichi, Senior Regulatory Programme Manager, F hoffmann La Roche, Basel, Switzerland*Mr Nigel Fox, Regulatory Program Manager, Roche Products Ltd, Welwyn Garden City, UK

Ms Carolina Arias, Sales Director, RR Donnelley, Life Sciences, London, UK Mr Sabeeh Habib-Ullah, Physics Teacher, London, UKDr Audrey Athlan, Chesterfield, UK Dr Tido Eger, Twickenham, UK*Mr Ankit Geete, Dist-Khandwa Madhaya Pradesh, India (Student)Dr Alex Bloom, Manager, London, UK*Mr Vivek Mhatre, Chatham, UK (Student)Dr Hayley Reid, Regulatory Affairs Associate, PRA International, Linlithgow, UK Dr Emma Craig, Regulatory Affairs Manager, Maidenhead, UK*Mrs Alison Malcolm, Bishop’s Stortford, UK*Ms Michaela Nahler, Germany (Student)Mr Thomas Breslin, Bundoran, Ireland*Dr Carlo Berti, Carlo Berti Ltd, Wakefield, UK*Mr Aqib Khan, Luton, UK (Student)Mr Mark Willoughby, Regulatory Operations Manager, RB Pharmaceuticals Ltd, Slough, UK*Miss Louise Ellis, Cancer Research UK, London, UK

TOPRA welcomes the following new members who joined recently

InTouch Editors: Jenine Willis, Greer Deal and Ishbel MacDonald

Assistant Editor:Rachel Cook

How to contact InTouchInTouch 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/intouchViews 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

TOPRABellerive house 3 Muirfield Crescent London E14 9SZTel: +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 €225. TOPRA members can read or download InTouch online at www.topra.org