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T h e T O P R A N e w s l e tt e r – K e e ping m e m b e rs in T o u c h
In this issue... Following the lull of the summer months, and now that everyone is back from their holidays, there seems to be a frenzy of activity. TOPRA is no exception. There’s the TOPRA Annual Symposium which has just taken place – look out for coverage in next month’s InTouch. We are now looking forward to the Awards for Regulatory Excellence which will be held next month. I’d like to take this opportunity to congratulate the shortlisted nominees (see page 2). It’s your opportunity to vote new members to the Board in the next few weeks. Please find out more about the candidates on page 3. Looking to the future, I’ve spotted that TOPRA’s ever-growing membership is becoming increasingly global. With new members from as far as the United Arab Emirates, Malaysia and Australia – welcome to you all! Greer Deal, Co-editor, InTouch
Have your say
A message from Patrizia Nestby, TOPRA President It is a very busy time of year for TOPRA with the Annual Symposium, the Regulatory Affairs Awards and, most importantly, for every member the TOPRA Board Elections. This year we have elections for both President Elect and four Directors. For full information on all the candidates and the election process go to page 3. The elections are your opportunity to have a say in the composition of the TOPRA Board and how our organisation will take shape in future. I encourage you to cast your vote!
NEWS FROM THE TOPRA MEMBERSHIP TEAM
In this month’s column, Head of Membership Duncan Judd focuses on networking via the Special Interest Networks (SPINs) TOPRA members are very passionate about regulatory affairs and this enables us to continue to develop our networks that bring members together. TOPRA Special Interest Networks are one of the main benefits of membership. They create an environment to facilitate neutral and independent discussion within a face-to-face or virtual context. We have active SPINs for Clinical Trials, CMC (Chemistry, Manufacturing and Controls), Electronic Regulatory Affairs, Med Tech, Pharmacovigilance, Regulatory Intelligence and Veterinary. Taking part in SPINs, and volunteering in general with
TOPRA, helps members both gain insight into regulatory issues from their peers as well as give back to the profession by sharing knowledge and forms of best practice that can assist other members in their regulatory roles. Members really value the ability to become part of a community of professionals that has an identity and respect. A recent Med Tech SPIN meeting in the TOPRA office, for example, produced a day of keen discussion. On the same day, a virtual VET SPIN meeting was held remotely for vet members. I am assisting with the development of all our networks and this will be facilitated by a new database and website. By early
TOPRA In Updates
2014 members will be able to see the benefits of this new approach. It will enable members to interact with others in the same networks, instant messaging for Q&A, access to meeting dates, downloadable information and minutes and will allow members to join any of the networks they wish to. If you want to know more about how to join a SPIN, or TOPRA In group, or for information on what they involve and when their next meeting dates are then please e-mail me at duncan@ topra.org. I look forward to updating you all on the next stage of developments with your membership soon.
A recent TOPRA In Switzerland networking event at switzerland Clinipace, Zurich brought TOPRA members together from all over Switzerland and the surrounding regions for an evening of networking. There were discussions on the challenges of managing eSubmissions and implementing eCTD in Global Organisations, while representatives from the local agency Swissmedic also discussed issues. The event was a great success and was followed by informal networking for all TOPRA In members. The next TOPRA In networking meetings are due to be held in Dublin on 22 October for TOPRA In Ireland, along with an international TOPRA In event to be held in Austria on 14 November for members in Austria, Sweden, Italy, France, Spain and Portugal.
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TOPRA REGULATORY AFFAIRS AWARDS 2013
THE SHORTLISTS
TOPRA is pleased to announce the shortlisted nominees for the Awards for Regulatory Excellence, due to be held at the Institute of Directors in London on 27 November COMMUNICATION
HORIZON
SUPPORT
● Gavin
● Andrea
Quaye, Regulatory Affairs Consultant, Pfizer, Surrey, UK ● Kathryn Parsley, Senior Regulatory Affairs Specialist, PPD, Cambridge, UK ● Sarah Bentouati, Regulatory Program Manager, Roche, Basel, Switzerland
● Triskel
EDUCATION
INSPIRATION
● Tony
● Gert
Edwards, Manager, Integrated Product Development, PAREXEL Consulting, Uxbridge, UK ● Sue Harris, Unit Manager, MHRA, London, UK ● Auditgraph team led by Mauricha Marcussen, CEO, Agano Solutions, Ohio, US
INNOVATION ● Diamond
BioPharm, Harlow, UK ● mRTS (MakroCare Regulatory Tracking System), New Jersey, USA ● On-course®, IMI EMTRAIN team, Medical University of Vienna and University of Manchester
Cartwright, Independent Regulatory Affairs Adviser, Hertfordshire, UK ● F Hoffmann - La Roche Regulatory Team, Basel, Switzerland ● Anne Tomalin, Managing Director, OptumInsight, Ontario, Canada
team, Triskel Integrated Services, Geneva, Switzerland ● Gillian Traynor, Director, Albany Regulatory Consulting, Cambridge, UK ● Regulis Consulting Regulatory Team, Regulis, Hertfordshire, UK
Bos, Head of Regulatory and Clinical Affairs, British Standards Institution, UK ● Chris Griffett, New Jersey, US ● Sushma Sanger, Pfizer, Surrey, UK
To find out more information on the shortlisted nominees and how to book your seat at the prestigious Awards Dinner and Ceremony go to www.regulatoryaffairsawards.org/shortlists or email awards@topra.org
PPD AND PAREXEL JOIN OUR TEAM OF CATEGORY SPONSORS THIS YEAR TOPRA is pleased to welcome PPD and PAREXEL as sponsors this year. PPD is supporting the COMMUNICATION category again this year and PAREXEL will be supporting HORIZON again after a one-year gap. Paul Bridges, Corporate VP, PAREXEL explains “The HORIZON Award celebrates the achievements and success of regulatory professionals who are newcomers to the industry. Understanding that recognition is a key motivator in the development of competence and skill, PAREXEL is delighted to support this award and to
celebrate the recipients”. Elizabeth Madichie from PPD also spoke in support of the Communication category, explaining that “PPD prides itself on excellent communication skills with our internal and external partners, which contribute to company success. This is especially important within the regulatory affairs team and across our global footprint. We are delighted to sponsor the Communication Award again this year to acknowledge the talented regulatory affairs professionals who are deserving of this prestigious award.”
Our ongoing thanks also go to Samarind RMS, which is supporting the INNOVATION Award and Clinical Professionals, which is supporting the INSPIRATION Award. No matter what the size of your organisation, it’s not too late to align your company with the ethos of excellent regulatory practice and help raise the profile of regulatory professionals. Go to www.regulatoryaffairsawards.org/ sponsorship or contact mark.wilkins@ ashridgecommunications.com for further details.
RMS samarind regulatory management software Innovation Award
w w w. t o p ra . o r g / i n t o u c h
Inspiration Award
Communication Award Horizon Award
O cto be r 2013
T h e TO PR A Ne wsle tt er – K eeping mem b e rs in To uc h
News
TOPRA BOARD ELECTION UPDATE
It’s time to make your decision There has been a great response to our call for nominations to the TOPRA Board, so we are now running elections for President Elect and the four director posts. The full list of candidates [in alphabetical order] is listed in the table below with their nominators.
Members will note that one candidate has been nominated for both the President-Elect and Director positions, which is allowable under our current constitution and electoral procedures. Members should consider the
candidates for the two distinct roles (that of President-Elect and Director) separately and vote for the candidate who they feel would be best for each role. You will find full details for each of the candidates on the TOPRA website – go to www.topra.org/elections
POSITION
NOMINEE
PROPOSER
SECONDER (1)
SECONDER (2)
PRESIDENT-ELECT
Carlos Langezaal
Craig McCarthy
Axel Wenzel
Monique Garrett
PRESIDENT-ELECT
Sarah Roberts
Patrizia Nestby
Jonathan Trethowan
Angela Stokes
DIRECTOR
Bob Clay
Graham Higson
Ali Harrison
Rhiannon Davies
DIRECTOR
Tacye Connelly
Lorna Griffin
Jason Collins
Shaun Stapleton
DIRECTOR
Judith Creba
Nick Sykes
Fiona Reekie
Mireille Muller
DIRECTOR
Thomas Kühler
Patrizia Nestby
Merete Schmiegelow
Angelica Joos
DIRECTOR
Carlos Langezaal
Craig McCarthy
Axel Wenzel
Monique Garrett
DIRECTOR
Christine Mayer Nicolai
Helene Thybo
Nick Sykes
Liz Gifford
DIRECTOR
Angela Stokes
Alan Newlands
Paul Jeffreys
Sarah Roberts
Carlos
Sarah
Bob
Tacye
VOTE, VOTE, VOTE… We invite ALL current and paid-up Members, Registered Members and Fellows (including Retired) to be part of the decision-making and to cast their votes by visiting www.topra.org/ board-elections-voting-form. In order to help you make your selection, the candidates have provided a brief summary of their intentions in standing for election and these are also available to read on the website. Members will be asked to select ONE candidate for PresidentElect and up to FOUR candidates for Director positions. The four candidates with the highest number of votes will be elected as Directors.
Please note that Honorary Life Members, Student members and members of the TOPRA Linked In group who are not also paid-up TOPRA members, do NOT have voting rights. Votes will be automatically counted but they will all be checked to ensure that they have been submitted by an eligible paidup member and that each member has only voted on one occasion for each position. Your vote, however, will be treated as confidential and reviewed only by our nominated Returning Officer.
Clearly, it is not possible for the candidate who has stood for both roles to be elected to both positions. Therefore in the event that he receives the highest number of votes for PresidentElect, he will be withdrawn from the contest for Director. In the event that he does not receive the most votes for President-Elect, he will continue to be part of the election for Director. Only the votes cast for him in that role will be taken into consideration when considering the results for the Director positions.
Your vote must be received by 6pm UK time on Wednesday 20 November 2013. Any votes received after this time will not be counted.
Judith
Thomas
Christine
Angela
The RESULTS
The results of the Election will be announced at the TOPRA Annual Review Meeting and EGM on Wednesday 27 November 2013, which this year will be held immediately prior to the TOPRA Annual Lecture and Awards evening at the Institute of Directors, Pall Mall, London. The newly elected Board members will take up their posts from 1 January 2014 and will serve for a term of one year in accordance with the constitution.
A u g u st 2 0 0 9
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Viv Edwards takes up new regulatory post
InTouch Editors:
A TOPRA member for 10 years, Dr Viv Edwards has more than 15 years’ experience in product registration across the respiratory, gastrointestinal, musculoskeletal and women’s health categories.
Dr V iv Edwards
She has recently been appointed in the newly created position of Director of Regulatory and Medical Affairs at infirst HEALTHCARE. Viv has moved from Procter & Gamble having worked in the Consumer Healthcare and Pharmaceuticals divisions. Manfred Scheske, Chief Executive Officer of infirst HEALTHCARE, says: ‘We are delighted to welcome Viv to our team. Viv shares our passion to make a real difference to people’s lives by making known drugs better.’
A regulator who will be sadly missed George Wade, a long-standing member and friend of TOPRA, died peacefully on the 3 October after a long battle with cancer. George joined BIRA while working in the pharmaceutical industry. He gave many presentations from his unique perspective as a leading regulator within the EMA. He was a principal pharmacist within the Medicines Control Agency (MCA) in the European Licensing Unit under the direction of Tony Cartwright. With the creation of the EMEA in 1995 it was a natural progression to move to the new Agency, where he was a leading project manager and supported the quality working party. He also helped develop several key
policies, including the assessment of drug device combinations. He was a knowledgeable, pragmatic, problem-solving assessor. Countless patients across the world owe the high quality of medicines to his work. He was a ‘go to’ regulator. Following the death of his wife, George brought up their young daughter. He had many outside interests and it is regrettable he was not able to pursue these in his all too short retirement. George was a good friend and colleague who will be greatly missed by many across the whole spectrum of regulatory science.
NEWTOPRAMEMBERS TOPRA welcomes the following new members who joined recently
Mrs Susan Nixon, Global Regulatory Affairs Intelligence & Policy Manager, Novartis Consumer Health SA, Nyon, Switzerland Mr Ben Jacoby, UK* Ms Deirdre McManus, Regulatory Operations Officer, GlaxoSmithKline UK Ltd, Uxbridge, UK Dr Mark Ammann, President, Catalyst Regulatory Services, LLC, Dexter, USA Ms Elsa Vecino, Technical Director, EGGVP, Brussels, Belgium Dr Christian Kutzleb, Manager Regulatory Affairs, Almirall Hermal GmbH, Reinbek, Germany* Mrs Anne Dal Pra, Regulatory & Safety Intelligence Manager, Sanofi-aventis Research & Development, Chilly-Mazarin, France Ms Nicole Jackson, Regulatory Affairs Associate, M&A Pharmachem Ltd, Bolton, UK Dr Mary-Beth Daniel, Medical & Regulatory Affairs Project Administrator, Walthamstow, UK Ms Louise Downer, Consultant, Esher, UK Mrs Ivelina Pencheva, Regulatory Affairs Assistant, Pharma Support Services Ltd, Sofia, Bulgaria
Ms Monica da Silva, Compliance Officer, London, UK Miss Kate Nicholson, Hull, UK (Student) Miss Shabana Patel, Associate Consultant Regulatory Affairs, Ilford, UK* Mr Bhushan Sarode, Vaud, Switzerland (Student) Mr Moshin Malik, Regulatory Affairs Associate Consultant, Parexel, Slough, UK* Dr Philippe Karl, Head of QA & RA, Sanofi-Aventis (Suisse) SA, Gulmmatt, Switzerland Mr Tim Stevenson, Senior Recruitment Consultant, Matchtech Group PLC, Whiteley, UK Dr Helen Donnelly, Manager, Kinapse Ltd, Regulatory Affairs, Wimbledon, UK* Miss Sabistan Davar, Clinical Trial Lead, GlaxoSmithKline, Uxbridge, UK* Mr K VanLuvanee, President/ CEO, Virtual Regulatory Solutions Inc, Schwenksville, USA Mrs Karin Grosch, Holo, Sweden Mr Latino Massimo, Senior Director, Global Regulatory Affairs, Pessano con Bornago, Italy Mr Shankar Suresh, Birmingham, UK (Student)
Mrs Carlota Vinals, Brussels, Belgium* Mrs Vilma Costa, Director, Regulaffairs, Barcelona, Spain* Mrs Anne Ravnholdt Hoecker, H Lundbeck A/S, Pharmaceutical Scientist, Denmark* Ms Lee Lee Lim, Senior Regulatory Affairs Associate, InQpharm Group, Malaysia Ms Laura Zitare, Riga, Latvia* Mr Shawn Nelson, Enfield, UK Mrs Sarah Barrs, Hampshire, UK* Miss Katarzyna Szafranska, Cambridge, UK (Student) Ms Isabelle De Montazet, GRA Regulatory Operations Manager, Novartis Consumer Health SA, Nyon, Switzerland* Mr Stephen Galvin, Regulatory Scientist, Eli Lilly SA Irish Branch, Co. Cork, Ireland* Ms Margarita De La Puente Janez, Campo Real, Spain Mr James Pink, Vice President, NSF-DBA, Rotherham, UK* Miss Nicola Watts, Editor OTC, Nicholas Hall & Company, Southend-on-Sea, UK Dr Orit Beilin, Regulatory Affairs Associate, Raanana, Israel* Dr Quan Yang, Pharmaceutical Assessor, Woking, UK* Mr Sanjay Jain, London, UK
Ms Yvette Cleland, Group Managing Director, Clinical Professionals, UK* Miss Andrea Hermosa Rubio, Orton Malborne, UK (Student) Ms Kathe Byrstrom, Director, Stockholm, Sweden* Ms Amel Belacel, Regulatory Affairs Associate, Reckitt Benckiser, United Arab Emirates* Dr Satyam Upadrashta, Waltham, USA* Ms Jana Reitmajer, Swords, Ireland (Student) Miss Deborah McConnell, Regulatory Affairs Officer, Merck Sharp & Dohme Ltd, Hoddesdon, UK* Miss Crystal Mok, Cambridge, UK (Student) Mr Amar Patel, Pinner, UK (Student) Mrs Louise Moore, The Gap, Australia* Mrs Nicky Cosens, Regulatory Affairs Consultant, Nicky Ellis Regulatory Services Ltd, Henlow, UK Mr Zaid Hussain, London, UK (Student) Dr Johan Hellmer, PV Director, S-berg, Sweden
*Registered Member
Jenine Willis, Greer Deal and Ishbel MacDonald
Editorial support: 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. © 2013 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 €225. 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.
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