July/August 2014
The TOPRA Newsletter – Keeping members in Touch
In this issue... There are several ‘new beginnings’ in this edition of InTouch: a baby, a marriage, four new TOPRA fellows and the oncoming Escher Project – so it looks as though there is plenty for us to look forward to! Don’t forget the call for nominations to the TOPRA Board for 2015! If you’d like to become part of this trend for ‘new beginnings’ please take this opportunity to nominate yourself or your colleagues and become part of TOPRA’s future. Of equal importance is to reflect on past achievements, so it’s great to hear that 2014 has surpassed previous years for the number of nominations received for the TOPRA Awards – congratulations to all! Greer Deal Regulatory Consultant, MacDonald Regulatory Ltd Co-Editor, InTouch
Shaping our profession Jonathan Trethowan, TOPRA President
Welcome to the summer edition of InTouch. I’m sure many of us are looking forward to a well-earned break, either during the school holidays or perhaps you try to avoid these busier times! Later this month I will be packing the car, catching the Plymouth to Roscoff ferry and driving the 900km to the Midi-Pyrénées region of France for two weeks of activities and camping with the children. I’m hoping for a good settled spell of weather for this trip, but certainly have no intention of letting a bit of inclement weather dampen the enjoyment. Nominations are in! I was delighted to hear that this year more nominations than ever have been received for the Awards for Regulatory Excellence. I would like to say a massive ‘thank you’ to everyone who has invested the time to consider and make these nominations – without these the Awards would not be possible. I would also like to thank the office team and the Awards Working Party whose dedication and commitment to celebrating our achievements are the driving force behind this event. It is now over to the judges, including myself, who have the challenge
of determining our shortlist and winners. Watch this space! Call for speakers Following the outstanding success of the Fellows Dinner in June with Dr Ian Hudson (see page 2), I want to maintain the momentum this event has generated. To achieve this we need a quality programme of topics and speakers. These are member events and allow us to facilitate access for our members to thought leaders and topics that interest them. Therefore I would ask everyone to support the TOPRA office by contacting them with suggestions for topics and/or speakers. Escher Project On 18 September TOPRA will be holding a joint meeting with the DIA on ‘Lessons from the Escher Project’. The Escher Project (see page 4) is made up of a number of projects – completed and ongoing – focused to initiate research and policy debate on the development, marketing
authorisation, reimbursement and use of medicines. The project goal is to facilitate patient access to medicines and innovative technologies that address public health needs. More information is available on the project website – please visit http://escher-projects.org. This project, along with its findings, will shape the future of our profession and how we interact with other disciplines. Therefore I urge you to keep updated with this project. Our meeting in September is a great opportunity to hear from the key players involved and the vital lessons that have been learned to date. I am looking forward to the second half of 2014 and the exciting plans we have. In closing I would like to send my best wishes to everyone for a fantastic summer.
thank you for your nominations!
2014
Registrations for the 2014 Regulatory Affairs Awards have now closed, and we would like to thank everyone who has taken the time to share with us some examples of outstanding work in our profession. Shortlists will be announced in September – watch this space!
INNOVATION
CHAMPION
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
north american news
TOPRA Board member and North American Representative Patricia Duchene and her husband Laurent are the proud parents of a baby girl. Emma was born on 7 July, weighing 7lb 3oz – many congratulations!
The TOPRA North America Leadership Team (NALT) held its annual face-to-face meeting in New Jersey on 12 May The meeting focused on the scope of TOPRA membership in this region and looked towards the planning of TOPRA North America events to be held in 2014–15. These include the Essentials of EU Regulatory Affairs courses and upcoming webcast programmes, as well as the North America focus to the November 2014 issue of the Regulatory Rapporteur. Eleven US and Canadian colleagues were able to join the gathering along with TOPRA staff from London, and the NALT was delighted to have Lynda Wight (Executive Director, TOPRA) join the meeting in person.
MEMBERSHIP NEWS
congratulations
Gillian Ivers-Read, Clovis Oncology
Sarah Roberts, PRA
Alan Newlands, Clovis Oncology
Eva Kopecna, Teva
to our new fellows
This month we are pleased to announce the addition of four new TOPRA Fellows to our membership: Gillian Ivers-Read, Sarah Roberts, Alan Newlands and Eva Kopecna. Gillian has more than 20 years’ experience in regulatory affairs – most of that time spent in senior RA positions in big pharma or in smaller biotech companies. She is a founding member of the NALT created in 2004, and has been Executive Vice President, Technical Operations and Chief Regulatory Officer at Clovis Oncology since 2009. Sarah Roberts, TOPRA President-Elect, has a scientific background in oncology research, moving into regulatory affairs in 2002 as a consultant with global CRO MDS Pharma Services. In 2010 Sarah helped establish and chair the TOPRA Clinical Trials Special Interest (SPIN) group. As Executive Director of Global Regulatory Affairs at PRA International, she manages a global team of over 200 regulatory professionals. Alan Newlands has worked in regulatory affairs for more than 20 years following his PhD in Drug Metabolism. He has been influential in regulatory training and mentoring, and contributes articles to the Regulatory Rapporteur. Alan is Vice President of Regulatory Affairs at Clovis Oncology with reponsibility for all regulatory activities outside of North America. Eva worked as a hospital physician for almost 10 years before moving into the pharmaceutical industry. She began her regulatory career in 1999 at Galena and has since progressed steadily while working for small and large pharmaceutical companies. Eva has been influential in regulatory training acting as Module Leader for the
MSc, and is Head of Regulatory Affairs at Teva.
TOPRA InTouch Newsletter – July/August 2014
TOPRA FELLOWS’
DINNER A Dinner held for the TOPRA Fellows and Honorary Life Members took place at Villandry in London on 11 June, where Dr Ian Hudson (Chief Executive, MHRA) introduced the MHRA’s plan for early access to medicine. The enjoyable evening was an ideal opportunity to catch up with colleagues and friends!
TOPRA InTouch Newsletter – July/August 2014
elections for president-elect, north america and eu representatives
your chance to stand for the topra board
All members should have received a call for nominations to the Board for 2015, outlining the opportunity to nominate colleagues from the membership to stand for election. Please consider standing and making your contribution to your professional organisation
The following positions will fall vacant at the end of 2014 as the current post holders complete their terms of service PRESIDENT-ELECT
Nominations are invited to this post, which is for a one-year term. The successful candidate will then serve a further one year as the TOPRA President and a final one year as Past-President.
NORTH AMERICA REPRESENTATIVE
These are positions that are held for two years (for a maximum of two consecutive two-year terms). These Board Directors have oversight of the activities of TOPRA in the specific regions including our active ‘TOPRA In’ groups. Together with the rest of the Board they have the legal and financial responsibility for TOPRA, setting and monitoring its strategy and overseeing the work of the staff.
EU REPRESENTATIVE
Why stand for election? This is a real chance for a regulatory professional to influence the work of their professional body and to offer their time and talents to promoting TOPRA and the profession of regulatory affairs in general. Board members are volunteers but they also enjoy the benefits of being leaders of an organisation that is increasingly high profile and influential and they have a real chance to shape the way forward for TOPRA. Members of the Board participate in the Advisory Council with leading figures in the regulatory affairs world and have opportunities to attend conferences and meetings that help develop their personal regulatory intelligence and networks. Participation in TOPRA at Board level is a significant personal development opportunity, raises your personal profile and above all is a chance to ‘put something back’ into the profession. The organisation encourages all members to consider standing for election.
Going the extra mile The Distinguished Service and Top Team Awards recognise individuals and teams who have gone over and above in a volunteering project for TOPRA. Visit www.topra.org/volunteering to make your nominations by 31 August 2014. Winners will be announced at the Annual Review Meeting, held on Tuesday 13 October at the Annual Symposium in Brussels.
HOW TO MAKE A
NOMINATION
If you would like to stand for these positions you will need to complete a nomination form containing the following: ● the signatures of three other TOPRA members
● a statement from you which explains why you wish to stand and what you think you would bring to the Board. The nomination form is available on the website: https://www.topra.org/boardnominations-14 Nominations must be received at the TOPRA Offices by post, fax or email by close of business on Wednesday 20 August 2014.
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
TOPRA InTouch Newsletter – July/August 2014
TOPRA in partnership
InTouch Editors: Greer Deal, Ishbel MacDonald, Graeme Ladds and Jenine Willis
Part of the Board’s strategic plan is for TOPRA to engage in partnerships with other organisations, where this will be of value to our members and the wider regulatory community To date TOPRA has worked together with national agencies, the EMA, the EU Commission, trade associations and other professional bodies. One collaboration that will be of particular interest to members is the joint conference we are holding with DIA in Brussels on 18 September. The subject of the conference is the Escher Project. This is a project undertaken with the support of EFPIA, AESGP and academic and research institutions, looking at the future of medicines regulation. There is increasing concern that, apart from all the benefits of drug regulation, the balance
may have shifted towards over-regulation with apparent threats to drug innovation in general. The Escher Project has two aims: to identify areas for potential improvement within the EU regulatory system that will positively affect innovative research and development, especially for products that address medical need/priority medicines; and to generate evidence on the underlying problems with the regulatory system to help inform the agenda for policymaking at the European and national level. The project is due to report in the autumn and the TOPRA/DIA event
Regulatory capacity for the future in TOPRA The day to day activities of TOPRA benefit greatly from the regulatory expertise of the volunteers, but it is necessary for the office team to have a good base of regulatory knowledge to play their part. This is not only in planning events or editing the journal, but perhaps more crucially in the external relationships TOPRA has and in planning for future developments that will benefit members and the profession as a whole. Sharp-eyed readers of the Regulatory Rapporteur may have noticed a recent advertisement for a senior person to take on some of these activities from 2015, initially on a part time basis with a view to taking on greater commitment for the organisation as a whole in the next two years. This role would be ideal for someone who is looking for a transition into a new career in the non-profit sector, using their regulatory and business competencies and putting something back into their profession. If this sounds interesting you can enquire for more information in strictest confidence from lynda@topra.org.
Assistant Editor: Rachel Cook
will be an opportunity for those who are not familiar with it to hear about the outputs almost as soon as they are published, and to debate what the next steps might be in a series of workshop settings. This meeting will be of great value to regulatory professionals working in EFPIA/AESGP members but also to those in other companies and consultancies who may not otherwise have an opportunity to take part in the discussion. Speakers from companies, the EMA and the Commission have been invited so look out for the brochure and make sure you can attend!
congratulations
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. © 2014 The Organisation for Professionals in Regulatory Affairs
from topra!
TOPRA
TOPRA’s Postgraduate Administrator Kay Wood and her new husband Gareth Platt celebrated their wedding on 7 June. We wish them every happiness for the future!
Tel: +44 (0) 20 7510 2560 Fax: +44 (0) 20 7537 2003 E-mail: topra@topra.org
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InTouch is free to TOPRA members. Annual membership of TOPRA is £185. TOPRA members can read or download InTouch online at www.topra.org
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ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION