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N ov em ber 2011

T he T O P R A Newsletter – K eepi n g members i n T ouch

Going digital From 2012, editions of InTouch will no longer be published in paper format but will be available as a digital edition each month, which you can either view on screen or print off as required. 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 Jenine@topra.org if you have any questions or comments.

TOPRA apps TOPRA events apps for both iPhone and Android phones are now published and ready for download! Both can be found by searching for TOPRA on the relevant app store.

Writing editorials A message from David Jefferys, TOPRA President One of the roles and privileges of being the President of TOPRA is writing an editorial for each edition of InTouch. Writing such editorials has occurred several Dear times incolleagues my career, but I thought it would be valuable to seek some advice. I approached a distinguished politician, a senior clergyman and a journalist. The politician was very frank and said: ‘I would never write a monthly column, you are always a hostage to events; either you have to be general (and say nothing) or your words will be out of date.’ In his view you should only write a weekly column. The clergyman was more practical. He advised to make three points: the first two could be general topics, the third should be specific and leave the reader with a practical proposal which they could use and above all the editorial should be inspiring. The journalist, from a tabloid newspaper, recommended that the editorial should be provocative and seek to set up a debate. I am writing this editorial a week before the Annual Symposium in Rome. One prediction I can safely make is that we will have a successful and informationrich meeting. Looking at the agenda for the Annual Symposium causes me to reflect on why professional associations such as TOPRA exist.

One of the reasons is to maintain and enhance the standing of our profession and a second is to uphold professional standards. A third is to share and discuss important topics. I can predict that the next 12 months are going to be a period of major debate within the regulatory profession. The agenda will be full, with the proposals for revision of the Clinical Trials Directive, revisions to the Variations Regulation, discussions over the Transparency Directive and the recast of the Medical Devices Directive. The implementation of the Pharmacovigilance Directive will bring profound changes not only to

pharmacovigilance but also to many areas of regulatory affairs. As if this were not enough we will see debates over market access and the beginning of the debate over the revision of the pharmaceutical legislation which is due in 2014. TOPRA has an impressive programme to bring you the very latest and best information. If you are not already a member of TOPRA this is a great time to join. If you are, then I think you will be very glad that you are able to access our great programmes. Have I followed some of the advice given to me on writing an editorial? I will leave you to judge.

Validation The University of Wales has notified TOPRA that it is proposing to introduce a new validation process for its external courses, probably from the start of the 2012 academic year. This proposal will be discussed at the University Council later this year, and we will then be discussing with the university what changes (if any) this might make to how the TOPRA course is validated. In the meantime, there are no implications for students currently enrolled on or about to join the TOPRA MSc and we will continue to offer an excellent and high quality qualification in Regulatory Affairs. If any current or future student has any questions, please contact the TOPRA office for more information.


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When in Rome... Last month’s Annual Symposium has gone down in TOPRA history as one of the most successful ever – with a full and varied programme of content and as a great networking event. Almost 400 attendees from over 20 countries came to our eighth Symposium, which was held in conjunction with the Italian agency AIFA

Highlights from the TOPRA Annual Symposium 2011

 he exhibition attracted a wide range of companies who enjoyed T the opportunity to meet up with delegates during break times

Delegates had the opportunity to relax in a classical Roman setting at the Gala Dinner

Peter Bischoff-Everding from the Commission and TOPRA President David Jefferys at the Medical Devices Symposium

 irgilino Donini, the head of the V Italian veterinary agency and Maria Tollis from the Istituto Superiore di Sanità

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1 Professor Paolo Biffignandi presents Professor Guido Rasi, the Executive Director-Elect of the EMA, with his Honorary Life membership certificate 2-4 David Jefferys awards Honorary Life memberships to former Presidents: Alan Hunter (2), Margareth Jorvid (3) and Cheryl Hall (4)

 view from the floor of A the main symposium


N ov ember 2011

TO PR A R egulatory Affairs

Awards 2011 - UPDATE

TOPRA BOARD

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

Join us at the Awards Ceremony this month

In just a few weeks’ time – on 24 November – we will be celebrating the achievements of our winners and the shortlisted candidates for the TOPRA Regulatory Affairs Awards. The Awards Dinner and Ceremony will be held at the sumptuous Four Seasons Hotel in Canary Wharf. Why not book your seat at this prestigious event and congratulate the winners and shortlist in person? Many leading industry and regulatory agency figures will be attending as the event coincides with the Joint TOPRA/EMA Annual Review meeting in London. The evening will begin with pre-dinner drinks reception, sponsored by NDA Regulatory Group. Before the dinner begins, we will be congratulating our TOPRA MSc students who will be receiving their certificates. The Awards will take place after dinner in the hotel’s ballroom and the guests will be able to enjoy the spectacle and excitement of the ceremony in splendid surroundings. But the real business of course will be in the recognition of the importance of Regulatory Affairs to improving health and medical care and congratulating those who have contributed to the success and excellence of the profession. To book your place, go to www.regulatoryaffairsawards.org for a booking form or e-mail awards@topra.org. If you are unable to attend, look out for the souvenir edition of InTouch in January, which will include reports and photographs of the evening.

Jonathan Trethowan Jonathan set up TRAC, a Regulatory Affairs consultancy based in Cornwall, with his wife Sarah in 2001 and employs a regulatory team of 10 working with companies worldwide. He obtained a BSc in Biotechnology from the University of Westminster (then The Polytechnic of Central London) before gaining a PhD in Biochemistry from the University of London. Jonathan has spent his entire working career in the pharmaceutical industry. After completing his PhD he worked for GSK as a protein scientist and was involved in the design and development of downstream processing steps for therapeutic proteins (monoclonal antibodies). In 1997 his career in Regulatory Affairs began when he joined ML Laboratories. His time at ML gave him a varied workload, providing him with the skills and abilities needed to set up his own business as an independent regulatory affairs consultant. Jonathan has been an active member of TOPRA since 1997 and was recently elected a Fellow of TOPRA in recognition for his contribution to the organisation and Regulatory Affairs in general. Jonathan has received numerous business awards and won TOPRA’s Inspiration category at last year’s inaugural Regulatory Affairs Awards.

STOP PRESS – PAREXEL to sponsor HORIZON

We’re delighted to announce that PAREXEL has joined our distinguished team of RA supporters and will be sponsoring the HORIZON category, which recognises newcomers who are already making their mark on the profession. We’d also like to thank Samarind, supporting Life Time Achievement; Thomson Reuters, supporting Inspiration; NDA Group, as Regulatory Affairs Awards Champion; and our Media Sponsor Ash for their continued support of the Awards. There is still time for your company to support these prestigious awards – either as a Category Sponsor or as a Regulatory Affairs Award Champion, contact mark.wilkins@ashridgecommunications.com for more information.

Meetings with the EMA The TOPRA annual EMA update meeting will be held within the EMA this year. So if you have not been to the EMA before, 24-25 November 2011 is the time to visit. We hope that the new Executive Director of the EMA, Professor Guido Rasi, the former Director General of the Italian agency AIFA will be there. The two-day programme includes:

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Risk-Benefit in Action: How are the Centralised Procedure and Community Referrals changing

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Impact of pharmacovigilance legislation for patients, industry and member states.

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T he EMA Road Map – from vision to reality in 2012 and beyond

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C  HMP: Work programme and current issues

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P  ast experience and future trends for development of medicines in paediatrics and the elderly

See www.topra.org/ema2011

Health Technology Assessment

Christopher Bailey

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Veterinary workshop For those working in Veterinary Regulatory T he work of the EMA: hear how the Affairs and struggling with ‘e’ working, we EMA works at a practical level have a special one-day workshop with the B  enefit/Risk: what are the outcomes of EMA and the TIGes vet sub-group at TOPRA the three-year project on Risk-Benefit on the 14 December 2011 – see web page for details. decision making?


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N ov em ber 2011

InTouch Editors: Michael Bangs, Greer Deal and Virginia Guellal

Andrew Germain

Leslie Dowling

How to contact InTouch

Katriona Methven

Regulatory Rapporteur: A change of leadership The TOPRA Publishing team has said a heartfelt ‘thank you’ to Andrew Germain, who is stepping down from the role of Editor-in-Chief of Regulatory Rapporteur after three busy and fruitful years. It was under Andy’s stewardship that the editorial team won ‘Top Team’ award in 2010. While Andy will remain on the editorial panel, we are pleased to welcome the new Editor-in-Chief, Leslie Dowling of Gilead Sciences International, and new Deputy Editor, Katriona Methven of AstraZeneca. Leslie was previously Andy’s deputy and Katriona has been an inspiring consultant editor on several editions of the journal. Both have shown a great deal of commitment to Regulatory Rapporteur over the years and they are determined to build on the achievements that took place under Andy’s watch, and to further develop the content and range of coverage to ensure the journal is of an even higher quality and relevance to readers in the future.

Running for charity

Membership renewal by e-mail

Anne Wigmore put on her running shoes to take part in the 2011 Windsor Half Marathon on 25 September to raise money for Shooting Star CHASE, a charity that supports children with life-limiting conditions.

It will soon be time to renew your TOPRA membership for 2012

‘I did manage to get round and ran all the way, albeit rather slowly in 2.27 but that was good enough for me!’ she said. ‘I have raised almost £700 already and am still hoping to reach my target of £1,000. My page on justgiving at the link below will be open for a few more weeks if you did want to sponsor me but hadn’t quite got round to it’ (http://www.justgiving.com/anne-wigmore). Anne is a past Chair of BIRA and former Board member of TOPRA.

In order to make the process easier, TOPRA is introducing renewal reminders via e-mail. We hope you will continue to take advantage of the resources available to members, the valuable monthly publication Regulatory Rapporteur, Spin Group participation, Daily News feed via e-mail and much more.

NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently. A full list of new members can be found at www.topra.org/intouch. Mrs Brenda Ijeoma Mrs Katrin Rupalla Waltham Cross, UK (Student Celgene International Sarl, Member) Boudry, France

Miss Konstantina Miss Farrah Malik Papaspyridonos PharmaCare Europe Ltd, Specifar S.A., Athens, Greece Horsham, UK*

Dr Natascha Welzel Amgen, Vienna, Austria

Ms Madalena Olearczyk London, UK

Mrs Monica Bothwell Hungerford, UK

Dr Shagufta Ahmed Purley, UK

Mr Tim Twells Gilead Sciences Ltd, Cambridge, UK

Mr John Harvey Octagon Research Solutions, Quincy, US

Dr Alessandro Agostini G.A.B.A srl, Rome, Italy

Dr Barbara Mouzopoulou Holargos, Greece*

Mrs Nathalie ThomasPujol Maisons-Alfort, France*

Mr Ankush Shirish Patil Harrow, UK (Student Member)

Ms Veronika Ganeva Croydon, UK (Student Member)

Mrs Susanne Wessman Bayer AB, Solna, Sweden

Mrs Roza Saleh Northwood, UK

Dr Sara Fonseca Vifor Pharma, Neuilly-surSeine, France

Mr Frederic Cheneau Cephalon France, MaisonsAlfort, France Ms Marina Kochetkova MSD Pharmaceuticals, Moscow, Russia* Ms Isabel Diaz Ugalde Teva Europe BV, Harlow, UK

Mr Jean Colombel Dassault Systems, Velizy Villacoublay, France* Miss Nirvashi Ramgoolam Hounslow, UK Ms Ailish O’Driscoll Glanworth, Ireland

Ms Yumi Wenjie Zhao Toronto Canada (Student Member) Dr Fanny Masson F. Hoffmann La Roche Ltd, Basel, Switzerland Miss Avni Raichura Biogen Idec, Maidenhead, UK* Dr Joanne Hannam Cambridge, UK

Dr Simon Gallagher Slough, UK Dr Atsuhiro Kawaguchi Mitsubishi Pharma Europe, London, UK Dr Kara Johanna Purcell SEQ Ltd, Isle of Man, UK* Dr Darren Oakes Maidenhead, UK* Dr Carmen Masanneck Encorium Germany GmbH, Germany *Registered Member

InTouch welcomes contributions from TOPRA members. If you would like to contribute to the newsletter, or find out about deadlines, please contact Michael Bangs (Michael@topra.org) or Jenine Willis (Jenine@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. © 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: topra@topra.org InTouch is free to TOPRA members. Annual membership of TOPRA is €220. TOPRA members can read or download InTouch online at www.topra.org

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.

www.topra.org/intouch

TOPRA InTouch November 2011  

TOPRA InTouch November 2011