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D ecem ber 2011

T h e T O P R A N e wsl e tt e r – K e e ping m e m b e rs in T ouc h 


renewals The 2012 membership renewal process has already begun and members are now enjoying a simpler and faster process. There are now several ways to renew so you can find a way to suit you. To renew your membership for 2012: Online – go to: membershiprenewal2012 and complete the step-bystep process Phone – if it’s more convenient, you can pay by debit or credit card by phone. Please call: +44 207 510 2560 and quote your membership number Direct Debit – for forms, please e-mail: If you have any questions about your membership renewal, please contact the office on: +44 207 510 2560 or e-mail:

An era of profound change A message from David Jefferys, TOPRA President I thought I would share with you three reflections from the Annual Symposium held in Rome. My first reflection is that the Rome meeting, organised so magnificently by Paolo, his working party and the whole TOPRA team, was a great success and arguably one of the best symposia we have held.

Dear colleagues The meeting was well attended, with excellent engagement and highlevel debate amongst the participants. Unlike some other meetings, the TOPRA symposium considers topical and future issues with lively discussion and interaction. I believe this is helped by the fact that we do not have multiple tracks but try to preserve the meeting as an integrated event. This leads to my second reflection, which is that the regulatory profession is leading debates across several key issues affecting the Life Science sector. We are the people who know there has to be major regulatory reform. These deliberations were much in evidence during the Rome

symposium. It has been said before that: ‘A crisis should never be wasted, rather it should be a springboard for strategic development.’ My final reflection is that we are entering a period of profound change in healthcare regulation. This will be similar to the change seen in Europe in the mid 1990s. In Rome we heard of the implementation of the Pharmacovigilance Directive (and how this involves much more than pharmacovigilance), the major recast of the Medical Device Legislation, the revision of the Clinical Trials Directive and the renewed work on Patient Information. We also heard of major developments in Market Access and Health Technology Assessment.

I suspect the ongoing financial crisis in Europe will bring forth additional developments. This is a challenging, but also an exciting time to be in Regulatory Affairs, and I believe that TOPRA will be pivotal, helping the profession and providing platforms to facilitate the debates. This is not the last editorial I will write in 2011 but it is the last you will read, so I would like to take this opportunity to wish you all a very happy Christmas and a successful New Year. TOPRA will be at the centre of events in 2012 not least because the office is only two miles from the London Olympic Park!

TOPRA Regulatory Affairs Awards 2011 As InTouch goes to press this month, the Awards Ceremony is about to be held and the winners will be announced following a celebratory dinner at the Four Seasons Hotel in Canary Wharf on 24 November. It is a great setting in which TOPRA will recognise the high achievements and excellent practice within the Regulatory Affairs profession and of the companies and organisations that support this specialty. Look out for next month’s InTouch, which will focus on the Awards Ceremony and the TOPRA MSc students’ graduation. The January issue will be a souvenir pictorial edition, which will bring you all the excitement and drama of the evening. Celebrate the best that the Regulatory Affairs profession can offer by sharing this special digital edition with your friends and colleagues. And make a note in your diary next year to register your interest on the Awards website – www – or e-mail for further information on the TOPRA Awards 2012.

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The TOPRA Board for 2011-12 met for the first time at the offices in Docklands. From L-R: Jonathan Trethowan, Aine Kane, Steve Brookes, Patrizia Nestby, Niamh Lawler-Turner, Zubair Hussain, David Jefferys and Sarah Roberts. The missing person in the main photo is Monique Garrett (inset picture), the North America Representative who attended via telecon from the US.


Special Interest Network (SPIN) update

The Biotech SPIN has been in existence since 1996. We are in the process of rejuvenating this working group to better meet the needs of the busy biotech regulatory professional in 2012.

It’s goodbye from him Michael Bangs is retiring this month from editing InTouch. He was recruited by BIRA in 1997 to launch its new publication Regulatory Review. A few months later he also became Managing Editor of ESRA Rapporteur. When BIRA and ESRA were merged into TOPRA, the new publication Regulatory Rapporteur was launched and he continued as Managing Editor of that until early 2008, when he stepped down because of ill health. ‘I subsequently took on the editorship of InTouch, which I shared first with Karen Brown and then with Greer Deal and Virginia Guellal,’ he said. ‘It has been a pleasure to work with all of them.’ ‘When I started in 1997, I little imagined that I would still be working for effectively the same organisation in 2011. It has been fun and I have made many friends. Thank you all for making it relatively painless.’

The group is in place for TOPRA members with experience and/or an interest in Biotech Regulatory Affairs. The SPIN has a steering group made up of experienced members who are currently working in the field of Biopharmaceutical Regulatory Affairs and who co-ordinate a network and provide training and support to other TOPRA members to enable them to understand, interpret and influence the development of biotech guidelines as part of their ongoing professional development. The Mission statement of Biotech SPIN is ‘To promote the development of a realistic, common-sense and sciencebased approach to the regulation of biopharmaceuticals by providing a sound understanding of the basic science and the available and emerging regulatory guidance by creating a network for knowledge sharing and regulatory career.’

The objectives of the Biotech SPIN are: 1. To enhance and promote the image of TOPRA as the foremost global organisation for knowledge and training in the regulatory biopharmaceutical area.  2. To identify, highlight and communicate specific issues and significant new developments in the regulation of biopharmaceuticals by: Providing training and knowledge about biopharmaceutical processes and regulations through education modules and workshops for members and nonmembers of TOPRA Providing TOPRA membership with access to information via a structured publication strategy and web-based network.

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3. To liaise with TOPRA Strategic Committees and all other relevant TOPRA groups to ensure actions are consistent with the overall TOPRA objectives and are efficiently executed. 4. To promote and extend informal networks among all TOPRA members to ensure that bodies who can act as sources of advice and help in biotechnology issues are clearly identified. We have recently activated the e-network on the TOPRA webpage for any biotech related queries and will be providing a listing of activities for 2012 on the TOPRA Biotech SPIN webpage in January 2012.  We look forward to your involvement in the Biotech SPIN network. Please e-mail to join. Margaret Leahey

InTouch on-line InTouch is now a digital publication, which you can either view on screen or print as required each month. One of the key benefits of a digital edition is that it keeps the look of the newsletter but allows a more flexible format, eg, it can go up or down in size as required and the content can be hyperlinked to other information or more details on our website. We hope you will enjoy InTouch in this new format. Please contact if you have any questions or comments.

Decem be r 2011

Th e TO PR A Ne wsle tt er


Who’sWho A series in which InTouch profiles members of TOPRA’s governing body


Steve Brookes After brief careers as a sales executive and in the Department of Social Security, Steve joined the MCA (now MHRA) in 1992 in the labelling, leaflets and advertising unit. While at the MCA he completed an MSc in Biopharmacy from King’s College and led a team of assessors and administrators for the UK patient pack initiative. In 1997 he joined Wyeth’s UK affiliate where he gained regulatory experience with responsibility for Wyeth’s hospital products (oncology, women’s health and antiinfectives) plus line management. In 2001 Steve joined Wyeth’s Global Regulatory Department in the European Office with responsibility for new product development (inflammation, transplantation and GI medicine) plus line management. During his time at Wyeth, Steve was the European regulatory lead on the team responsible for developing the centrally authorised biological product Enbrel from $0.1B/yr to a $1.4B/yr product in Europe. In 2007 he joined the Global Regulatory Department of Johnson & Johnson Pharmaceutical Research & Development (PRD) as an Associate Director with EU regional responsibility for the antipsychotic Risperdal and ADHD treatment Concerta. In 2008 Steve re-joined Wyeth’s Global Regulatory Department as a Director with EU regional responsibility for women’s health, internal medicine and infectious disease products, including treatments for menopausal symptoms, osteoporosis, opioid induced constipation and river blindness. In mid 2009 he joined Biogen Idec as the TA Lead for Oncology, managing a small team with responsibility for regulatory development in Europe, Australasia and South America. Since entering the pharmaceutical industry, Steve has been an active member of TOPRA joining the Spring Introductory Course Working Party in 2001 and becoming the Chair in 2006. His leisure activities include playing football, cricket and golf, karate and occasionally playing guitar.

PROGRAMME 2012 TOPRA plans to boost its presence in Europe next year by increasing the number of courses delivered in mainland Europe where possible. For example, one of our five Pharmaceutical Basics Foundation Courses will be given in Europe while four will be held in the UK. In addition, it is hoped to deliver a Veterinary Basics Course in the UK and possibly a new Medical Devices Basics Course in Ireland. The successful and popular Introductory Courses will again be taking place next year, with the Spring Introductory Course based in the UK and the Autumn Introductory Course based in Prague. These are already in the planning stage. Here students will continue to have the opportunity to complete Module ‘0’ of the MSc and thus kickstart their MSc studies at the same time. The successful CRED programmes will continue on their cycle with topics on the following:

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LCM (Life Cycle Management) SmPC (Summary of Product Characteristics) ERP (European Regulatory Procedures) CMC (Chemistry, Manufacturing and Control) E-ctd (Electronic Common Technical Document) working Basics delivered twice in the year E-ctd (Electronic Common Technical Document) working Advanced delivered once.

The Current Awareness programmes will see TOPRA working to develop a joint course with the EU Commission in Brussels, together with other courses on Enpr-EMA (paediatric) and a risk/benefit programme also being put together. Our two MSc Courses will also be available, with five MSc Pharmaceutical Modules being planned for next year. One will be based in Munich, Germany, and another in Vienna, Austria, while the other three will be based in the UK. The Medical Technology Regulatory Affairs (MTRA) (Medical Device) modules will also be delivered at Cranfield but we are investigating delivering these at other sites in mainland Europe. Finally, as usual, we will be jointly delivering the annual EMA update, based in London in December, and our Annual Symposium is planned for Dublin next year on 1-3 October. Neil Fisher TOPRA Director of Education and Training

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D ecem ber 2011 The TRAC team with Jonathan and Sarah Trethowan

InTouch Editors:

TRAC Birthday Dinner Raises £1,600 for Cornwall’s 100 Club Cornish Regulatory Affairs Consultancy TRAC marked its 10th birthday in style when over 100 people attended a gala dinner to celebrate at the Tregenna Castle Hotel in St Ives recently. Members of the TRAC team joined with customers, suppliers and leaders from Cornwall’s business community to enjoy an evening of celebration and fundraising for the Cornwall 100 Club, the organisation that enables businesses in the county to give to a range of grass roots organisations and projects. Over £1,600 was raised. ‘We were absolutely delighted that our 10th birthday event was so well supported and that, as well as being able to celebrate, we were at the same time able to raise so much money for such a good cause,’ said company director Jonathan Trethowan. Since it was launched by Jonathan and Sarah Trethowan, the company has grown to its point today where it employs 13 people – the vast majority of whom have been recruited from the highly effective UCP – Unlocking Cornish Potential programme.

Dr Gemma Robinson with a Sean Egan crystal trophy, which she won recently as ‘Female Entrepreneur of the Year’, an award given by Enterprise Boards in the South of Ireland. She established Acorn Regulatory Consultancy Services Ltd in County Tipperary in 2002. In recent years the company has invested much time and money in developing the technical skills and know how to offer a full eCTD submission service. This has allowed Acorn to support many international companies in the Irish market and it has become the Irish affiliate for much larger worldwide Regulatory Affairs specialists. A mother of two toddlers, Gemma is keen to create a work life balance that means she can run a successful business while also having time for her family. She admits it is not always easy but with a great team around her at work and at home as well as liberal application of the family motto ‘Just get on with it’, she feels well equipped to deal with the challenges ahead.

NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently. A full list of new members can be found at

Mr Shehzad Ahmed Slough, UK Ms Catherine Akers Amgen Ltd Cambridge, UK* Ms Stephanie Anderson CanReg Inc, Dundas, Canada* Ms Serena Baldissera Bayer Consumer Care AG, Basel, Switzerland Dr Farid Benhammou Novagali Pharma, Evry, France* Mrs Ashmita Bhudia Edict Consulting Ltd, Bushey, UK* Miss Taranjeet Bolina Ilford, UK Mr Liam Brown G.R. Lane Health Products Ltd, Gloucester, UK Dr Miriam Brudy-Huls Reinach, Switzerland* Ms Eimear Butler Dublin, Ireland* Mr Oliver Cross Berkshire, UK* Mr Paul Dunn Quantum Pharmaceutical Ltd, Burnopfield, UK*

Mr Fredrik Engstrom Evolan Pharma AB, Danderyd, Sweden* Mr John Fletcher High Wycombe, UK* Ms Maricel Fong Celgene Corporation, Berkeley Heights, US* Mrs Pilar Garcia Crespo Novartis Consumer Health SA, Nyon, Switzerland* Mr Ben Greener Parexel International, Uxbridge, UK Mrs Ashley Hall Microment, Inc, Rockville, US* Dr Robin Henderson Boyd Consultants, Cambridge, UK* Mr Johan Holmgren AstraZeneca, Molndal, Sweden Mr Mohamed Ibrahiem Novagali Pharma, Evry, France Mrs Izabela Janiak Icon Clinical Reasearch, Langen, Germany* Dr Asad Khan Langley, UK*

Mr Thomas Kratz Ferring Pharmaceuticals A/S, Copenhagen, Denmark Dr Max Lagnado Edgware, UK* Mrs Tanja Megens De Lange Astellas Pharma Global Development Europe, Leiderdorp, The Netherlands Mrs Adeline MerletCantin Cephalon Europe, Maisons-Alfort, France* Mrs Camelia-Mihaela Mihaescu Alcon Romania SRL, Bucharest, Romania* Dr Shirin Mirshamsi London, UK* Mrs Clare Mosedale Pharmaxis Ltd, Frenchs Forest, Australia* Mr Raveesh Nayar Greenford, UK Ms Linh Palangie Genticel, Labege, France* Miss Jigna Patel Cambridge, UK

Ms Marisela del Carmen Poot Grajales GlaxoSmithKline, Brentford, UK*

Michael Bangs, Greer Deal and Virginia Guellal

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 Jenine Willis ( 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. © 2011 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 €220. TOPRA members can read or download InTouch online at

Mrs Beth Purdy Biogen Idec, Maidenhead, UK* Mrs Natalie Rousseau Henley-on-Thames, UK* Miss Corina Schmidt GlaxoSmithKline Biologicals, Wavre, Belgium* Miss Camille Segond Paris, France* Dr Ruchi Singh Reading, UK Mr Mike Stafford Stockport, UK* Dr Gaelle Tredan-Grosse Vifor Pharma France SA, Neuilly sur Seine, France* Dr Angelique Winzenrieth Aegerion Pharmaceuticals, Strasbourg, France*

*Registered Member

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.

TOPRA InTouch December 2011  

TOPRA InTouch December 2011

TOPRA InTouch December 2011  

TOPRA InTouch December 2011