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March 2014

The TOPRA Newsletter – Keeping members in Touch

In this issue... After the doom and gloom of the winter months, it’s great that spring seems to have finally arrived! Jonathan’s ‘reasons to be cheerful’ are apt. It’s so true that we, as regulatory professionals, can (and do) make a difference to patients’ lives. As TOPRA members our voices can be heard loud and clear so I would encourage everyone to share their thoughts and opinions with the membership. I also have another ‘reason to be cheerful’: I’m delighted to welcome Graeme Ladds, CEO of PharSafer, to the InTouch editorial team. Graeme is extremely well known in the Pharma industry with over 20 years experience focusing on Pharmacovigilance and Medical Information. I, for one, am looking forward to Graeme’s first InTouch introduction! Greer Deal Director, Global Regulatory Services Co-Editor, InTouch

Reasons to be cheerful... Jonathan Trethowan, TOPRA President

Following the months of very wet weather the outlook is looking brighter – not only in terms of weather. I’m writing this piece on 5 March which is Saint Piran’s day – the Patron Saint of Cornwall. While the festivities here may not reach the levels enjoyed by many on Saint Patrick’s Day in Ireland, I can assure everyone that it is a day of the year when Cornish pasty consumption hits a peak and I’ll certainly need to extend my run this evening to compensate. The other highlight is that it is not raining, which means that we are enjoying the first complete dry day in Cornwall since midDecember! In February it was a pleasure to attend the first TOPRA Roundtable for the year. I was delighted to meet some new people as well as catch up with familiar faces. We all enjoyed the discussion on the Empower Campaign which David Jefferys has kindly summarised for us in this issue. I particularly liked participating in a discussion that is on the periphery of my day-to-day experience, and feel that our knowledge and influence as

regulatory professionals is so valuable – we have the capability to make such an impact to patients’ lives. I encourage members to attend future Roundtable sessions. I am also keen to identify ways in which we can make these events even more accessible for our members to take part. For example, I would be interested to hear your views on attending a Roundtable-type session that is run as a webinar. Although our next Regulatory Awards for Excellence are some way off I am sure that you will have seen that preparations for 2014 Awards programme are well underway (see page 3). Having attended all of the Regulatory Awards Ceremonies to date I am thrilled to witness how the event has developed real traction and is building to be a key event in regulatory calendars. Events like the Awards are so important in many ways. We shouldn’t underestimate the importance of taking a step back from our busy professional lives to celebrate the incredible

achievements we are making in so many areas. I am particularly delighted to see the addition of two new awards categories this year: Contribution (recognising experienced individual regulatory professionals who do an excellent job) and Futures (acknowledging regulatory science in bringing innovative technologies and medicines to the clinic). These are a welcome addition to the existing seven categories and I encourage everyone to seriously consider making a nomination this year. Let’s make our 2014 Regulatory Awards our biggest celebration to date.

A Masterclass in US regulation

Masterclasses are three-day workshops aimed at experienced regulatory professionals who are looking for in-depth continuing professional development on specific regulatory topics. The latest Masterclass took place 4–6 February, and focused on the US Regulatory Environment.

Jim Hinson (Module Leader), Alan McEmber and Bob Clay.

A wide range of topics were covered, including the history of drug regulation in the US and FDA rules and regulations. The course was led by Jim Hinson of Rockwell Medical in Brighton, Michigan. He was joined by Randal Batenhorst, Vice President of Global Regulatory Affairs, GSK, US; Alan McEmber, Senior Director of Immunology, Global Regulatory Affairs, Abbott, US; and Bob Morgan, a Consultant based in Boston, US. Also speaking were Dr Sarah Roberts of PRA International and Bob Clay from AstraZeneca. Masterclasses can also be taken as part of the TOPRA MSc in Regulatory Affairs. This Masterclass was combined with Module 11, and it saw the introduction of two new students to the MSc: one from K-Pharma Consulting, UK and the other from Novartis Animal Health, Switzerland.


roundtable update

Access to Medicines – could the time be right...? Sir Peter Lachmann led the Roundtable discussions at the Royal Society on 5 February, with a presentation and discussion on ‘Access to Medicines and meeting the real needs of patients’ Despite appalling weather conditions and a tube strike, a significant number of TOPRA members came to hear Sir Peter Lachmann, a staunch supporter of Empower, which aims to make access to new medicines faster and more efficient. Empower was founded by Les Halpin, a biotechnology entrepreneur who suffered from motor neurone disease. Access to Medicines is a hot topic which goes to the heart of our work as regulatory professionals, particularly as there was a recent high level meeting in the UK Parliament and a lobby of Parliament on this subject is planned for the end of March. There is a widespread belief that this might be the right time to achieve change.

The talk highlighted some of the unintended consequences of the progressive introduction of medicines regulation over the past several decades – in particular the complexity of developing new medicines, the lengthening development timescale and the resulting high cost of modern medicines. The impact of litigation on drug development was highlighted and the emergence of an over-cautious regulatory system. It was made clear that there is no wish to change the controls on the quality and consistency of a medicine, nor on the studies required to fully characterise the metabolism, the safety and efficacy of the drug in animals. The central argument is that, where Phase II studies show favourable

TOPRA In Sweden A recent TOPRA In Sweden network meeting, held at the Medical Products Agency (MPA) in Uppsala on 30 January focused on medical devices legislation.

benefit–risk, then the remedy should be made available to those patients who agree to waive litigation rights and who are prepared to participate fully in follow-up surveillance. Inevitably, such proposals would need to be compatible with current European legislation, and will raise calls for no fault compensation. Following the presentation there was a lively discussion, and it was recognised that the determination of benefit–risk is at the centre of this debate. The key question is how much risk an individual patient and/or society is prepared to accept and who should set the threshold. A range of suggestions was made as to how some of the legislative and legal provisions might be

addressed and overcome. The arrival of powerful new biomarkers and the introduction of the ‘breakthrough medicines’ legislation in the US along with the ongoing discussions over ‘an early access scheme’ in the UK are signs that this debate is gaining traction. It was recognised that TOPRA members have much knowledge to contribute to this important debate. David Jefferys, former TOPRA President To find out more about Les Halpin and the Empower Campaign, go to the-campaign/les-halpin.

An audience of more than 70 people, from both industry and the MPA, attended the meeting. The topic ‘Current Regulation and future revision of the legislation of Medical Devices’ clearly garnered a great deal of interest. After a brief introduction, three presentations were given: • T he MPA’s roles and responsibilities and the process for market surveillance – Helena Dzojic, Head of the Medical Device Unit, MPA • C  linical trials/clinical assessment of medical devices – the clinical assessment report and the life cycle management and clinical trials with medical devices by Jan Thorelius, Clinical Assessor at the Medical Device unit at the MPA • M  DD (EU): a legislation in transformation – proposed changes and current status – Erik Hansson, Deputy Head of Health Technology and Cosmetics in DG SANCO at EC in Brussels, Chair of the Medical Device Expert Group and Borderline and Classification working group.

Helena Dzojic, Erik Hansson and Jan Thorelius at TOPRA in Sweden

TOPRA InTouch Newsletter – March 2014

The meeting delivered a successful mix of various aspects of the medical device legislation. It also included a follow up on the previously implemented updates of the directive, as well as the proposed new changes and experience from the CA perspective (MPA). It was interesting to hear about the measures already taken by the EC due to the PIP scandal before the new legislation has been finalised. Anna Mäkinen Salmi

Dr David Jefferys

TOPRA InTouch Newsletter – March 2014

2014 awards update

Nominations will open on 24 March for this year’s updated Awards Programme, providing you with the ideal opportunity to recognise your high-achieving colleagues, teams and organisations within the regulatory affairs community. This year there have been some exciting developments taking place, including the addition of two new categories: CONTRIBUTION and FUTURES, as outlined below. HORIZON CONTRIBUTION Recognising experienced individual RA professionals who do an excellent job

FUTURES Acknowledging regulatory science in bringing innovative technologies and medicines to the clinic

For recent entrants into the profession who have already shown great potential

INNOVATION Recognising the achievements of those who have significantly improved the regulatory process

INSPIRATION Acknowledging senior professionals who inspire and mentor others

COMMUNICATION Supporting regulatory professionals conveying complex healthcare messages to a broader audience

EDUCATION For educators and course leaders developing regulatory education

Who will you nominate? In the lead-up to the opening of nominations, now is an excellent time to start considering who you would like to recognise for their hard work and dedication to our profession. Judged by a prestigious panel of internationally renowned experts, the Awards for Regulatory Excellence cover a broad sector of the industry and acknowledge professionals from small service providers to big pharma. To register your interest in nominating or for attending the Awards ceremony later this year, please visit


For service providers and consultants who go the extra mile for their clients


This Award recognises individuals who have contributed to the profession and to healthcare over an entire career

Welcome to our new Judges! TOPRA is pleased to welcome the following distinguished professionals to our eminent judging panel, drawn from agencies, industry, law, academia and patient groups. Richard Barker, Director, CASMI Judith Creba, Head EU Liaison & Policy, Novartis Pharma AG Maureen Graham, Managing Director, Diamond BioPharm Ltd

Pat O’Mahony, Chief Executive, Irish Medicines Board Christa Wirthumer-Hoche, Head of Institute, AGES – Institute Market Authorisation & Lifecycle

Sheila Kelly, Executive Director, PAGB Alastair Kent, Director, Genetic Alliance UK Peter Lassoff, Vice President and Head of Global Regulatory Affairs, Quintiles Consulting Meredith Lloyd-Evans, Managing Director, BioBridge Ltd

Thank you to our Awards Sponsors!

Our special thanks go to Mary Baker, Ali Harrison, Aginus Kalis, Richard Tiner and Anthony Warnock-Smith who are stepping down as judges this year having supported the Awards since its launch in 2010.


TOPRA is grateful to our sponsors for the support given for the event – without them the celebration could not take place. We are very pleased to announce that Samarind will be sponsoring the Innovation category again this year. Their continued support for rewarding excellence in regulatory affairs is key to making the evening a success and one of the main events in the regulatory calendar. ‘Samarind is delighted to be sponsoring TOPRA’s Innovation Award again this year’ says Miranda Pothiawala, Samarind’s Software Director. ‘Winning the inaugural award in 2010 gave our team and our business a huge boost, so we know how important it is to encourage and reward innovation. We are great supporters of TOPRA and we look forward to presenting the Award to the winners, at what is now one of the key events in the regulatory calendar.’ To align your company with the ethos of these Awards by supporting a category or the Programme in general, please contact


TOPRA InTouch Newsletter – March 2014


Investing in our Members One of our main concerns is how we demonstrate value to our members. As I touched upon in February’s InTouch, we regularly gather information from our members to ensure that we are providing a broad and effective service. We understand our membership and have access to the latest information associated with regulatory affairs. We understand the age demographic, range of job roles, education and career background of our members, and are therefore in an ideal position to assist in your career progression. We aim to continually develop our member benefits and

services. Members will see our investment in the latest technology and social media in the next few months, particularly with the launch of the new database and website. Our commitment to professionalism ensures that regulatory affairs professionals always gain as much support, information and networking opportunities as possible. Feedback is welcomed, and members can also submit responses to consultations and help ensure that the regulatory voice is heard across the healthcare sector. We have also made sure that our annual subscription fee has not increased by more than 3% due to the economic

downturn, and we strive to help our members even further with more widespread career development programmes and access to the latest employment opportunities. The latest Regulatory Affairs Salary Survey, conducted by Clinical Professionals, has now been released. If you would like a free copy, please email me at We hope that our members will continue to get the most out of their membership throughout 2014 — our current membership renewal statistics are certainly very encouraging! I look forward to updating you all on the next stage of developments with your membership soon.


TOPRA welcomes the following new members who joined recently Mrs Sarah Kilpatrick, Victoria, Australia* Mr Arun Mahendran, Regulatory Affairs Executive, Convatec, Deeside, UK* Ms Hazel Hobbs, Regulatory Submissions Associate, Maidenhead, UK Ms Clare Horner, Junior Regulatory Officer, Thornton & Ross, Huddersfield, UK* Dr Pedro Lory, Regulatory Affairs Professional, Janssen Infectious Diseases BVBA, Beerse, Belgium Miss Masoumeh Bana, GE Healthcare Ltd, Amersham, UK* Dr Paschalis Dimopoulos, Regulatory Affairs Specialist, PPD, Cambridge, UK Ms Louisa Vangsted-Rees, Regulatory Administrator, United Therapeutics, Chertsey, UK Dr Rhys Whomsley, Director Exploratory Drug Development, Shire Pharmaceuticals, Basingstoke, UK Dr Mithu Sen, Abiogen Pharma, Director Regulatory Affairs, Pisa, Italy* Mr Alan Hennessy, Regulatory Affairs Officer, Clonmel Healthcare, Clonmel, Ireland Ms Louise Pett, Regulatory Affairs Consultant, TRAC Services, Redruth, UK Mr Michael Webb, Regulatory Affairs Consultant, TRAC Services, Redruth, UK

Mr Toby Butcher, Regulatory Affairs Consultant, TRAC Services Ltd, Redruth, UK Mr Paul Dearden, Regulatory Professional, Ulverston, UK Ms Alice Grasset, Director, GlaxoSmithKline, Wavre, Belgium* Ms Louise Wakefield, Regulatory Affairs Officer, GlaxoSmithKline, Barnard Castle, UK* Dr Natalie Thomas, Regulatory/ Clinical Consultant, Clinical Network Services (CNS) UK, St. Albans, UK Miss Merryn Collard, Regulatory Affairs Manager, Premier Research Group, Wokingham, UK* Dr Onjee Choi, Regulatory Affairs Associate, London, UK Dr Victoria Hayes, Regulatory Consultant, DLRC Ltd, Letchworth Garden City, UK* Mr Muhammad Ikram Gondal, Analytical Development Manager, Thomas Swan & Co, Consett, UK* Miss Meryll Rawet, Regulatory Associate II, Cambridge, UK Mrs Sarah Ghasemi, Surbiton, UK (Student) Ms Madhavi Govindaraju, Regulatory Affairs Officer, Sanofi, Guildford, UK Dr Kathleen Dawes, Regulatory Project Manager, GSK, Ware, UK*

Mr Yves Jonckheere, Interim Manager, Belgium Miss Beatrice Tilt, SunburyOn-Thames, UK (Student) Miss Rufaro Chigwada, Regulatory Affairs Associate, Parexel, Uxbridge, UK Mr William Johnson, Relief Pharmacist, Glasgow, UK Ms Ekaterina Gelman, EPFL Switzerland, Batiment SV, Switzerland Mr Daniel Bailey, Stockport, UK (Student) Dr Shahid Soomro, Manager Regulatory Affairs, Bremer Pharma GmbH, Warburg, Germany* Miss Delphine Laurent, Regulatory Affairs Process Associate, Elanco Animal Health, North Europe, Basingstoke, UK Miss Sandra Cardinal, Regulatory Affairs Associate, Parexel, Uxbridge, UK Dr Azgar Chughtai, Quality Assurance Manager, Pharmaspec, Birmingham, UK* Dr Charlotte De Leon, Regulatory Affairs Manager, Triomed AB, Lund, Sweden Mrs Eileen Smith, Senior Regulatory Affairs Specialist, PPD, Cambridge, UK Dr Marina Kraemer, Senior Specialist, PPD, Cambridge, UK Dr Vicki Brandt, Senior Regulatory Affairs Specialist, PPD, Cambridge, UK

Mr John Brandt, Senior Regulatory Affairs Specialist, PPD, Cambridge, UK Mr Ricardo Sanz-Gadea, Regulatory Affairs Manager, Premier Research, Madrid, Spain* Miss Elizabeth Ilett, Regulatory Affairs Officer, Meda Pharmaceuticals, Bishops Stortford, UK Ms Alexandra Oger, Merck Sharp & Dhome (Europe) Inc, Associate Director, Brussels, Belgium* Mrs Sylvie Delpy, Regulatory Affairs Consultant CR Pharma, Nice, France* Mrs Ini Okereke, Huddersfield, UK Ms Sumedha Malsure, Lausanne, Switzerland (Student) Miss Victoria Haslingden, Rugby, UK Mr Andrew Kelly, Castleknock, Ireland (Student) Dr Anna Mäkinen Salmi, Uppsala, Sweden* Miss Divya Magan, Tooting, UK (Student) Dr Tam Cilgi, Regulatory Strategy Manager, Reckitt Benckiser Pharmaceuticals, Slough, UK*

InTouch Editors: Greer Deal, Ishbel MacDonald, Graeme Ladds and Jenine Willis

Assistant Editor: 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 ( 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. © 2014 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 €225. TOPRA members can read or download InTouch online at

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 nos. 000055553-0001 and 0002.

*Registered Member


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