THE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCH

September 2015

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

By now, summer seems like a distant memory. My family and I were very lucky to enjoy a few days of sunshine on Tiree, a small island off the West Coast of Scotland. Scotland is not renowned for sunshine (especially true over the past couple of months), but Tiree boasts more hours of sunshine than the rest of the UK and this was certainly true for our visit. It is also quite windy. You perhaps may not be aware that each year Tiree hosts ‘Tiree Wave Classic’ – the world’s longest running professional windsurfing event. Although the locals will tell you that they get their roofs fixed during that week, as it is almost always the week in the year with the least wind!

This year we have received a great response to the call for nominations for the TOPRA Board positions in 2016 (see page 2). I would personally like to thank the candidates for putting themselves forward and for the commitment and

dedication they clearly have to TOPRA.

Now is the opportunity for you – the membership – to vote for the candidates that you want to see join the Board next year. I encourage you to take the time to read the candidate summaries available on the TOPRA website (www.topra.org/board-elections) which outline their intentions for TOPRA, and select the candidates you feel will best serve in each of the key roles for the organisation.

In this month’s issue of InTouch you will also see the Shortlists for the Awards for Regulatory Excellence 2015 (see page 3). On a personal note, it is fantastic to see individuals and companies who I have had the privilege of working with over the years being recognised for their work and achievements. Congratulations to all those who have been shortlisted and good luck!

Don’t forget that you too can

help support the nominees by attending the celebration, which will be held at the Royal College of Obstetricians and Gynaecologists on 18 November. To be part of this prestigious event, visit www.regulatoryaffairsawards/book and secure your place.

Last,but certainly not least, we are now just a few days away from the key event on the European healthcare regulatory calendar, the 12th TOPRA Annual Symposium in Berlin. This year’s theme is ‘Thinking Globally, Acting Locally’, and will be held on 12–14 October (see below).

The programme looks set to deliver an exceptionally engaging and valuable event for all and we hope to see many TOPRA members in Berlin!

SARAH ROBERTS, TOPRA PRESIDENT

It’s a big month for TOPRA with two important announcements: the release of the Shortlists for the Awards for Regulatory Excellence and the opening of the Board Elections for 2016!

Making your vote count

VISIT WWW.TOPRASYMPOSIUM.ORG TO SEE THE EXCELLENT SPEAKER PANEL AND TO BOOK YOUR PLACE!

Join us in Berlin for the Annual SymposiumTOPRA’s Annual Symposia – covering pharmaceuticals, veterinary medicines and medical devices – are together the largest forum for European regulatory professionals to meet up, discuss current regulatory issues and debate future plans for regulation.

Have you booked your place yet? A highlight in the regulatory calendar, this event will be held with the support of the Federal Institute for Drugs and Medical Devices (BfArM) on 12–14 October 2015 in Berlin, Germany.

In this issue...

This month we are at first taken to the beautiful island of Tiree in Scotland to calm us and allow reflection, before moving swiftly on to our busy schedule of events to come.

Firstly, we encourage all members to vote in the TOPRA Board Elections before voting closes next week (see page 2), as well as a timely reminder of the TOPRA Annual Symposium in October.

In this issue we also find out the final selection of those have been shortlisted in the Awards for Regulatory Excellence because of their brilliance; and of course their creative, innovative and supportive skills (see page 3). The Ceremony this year will be held in the Royal College of Obstetrics and Gynaecology – an amazing and truly inspiring venue.

Finally, we highlight a celebration for three members of the TRAC services team and our TOPRA running stars.

Ishbel MacDonaldRegulatory Consultant, MacDonald Regulatory LtdCo-Editor, InTouch

TOPRA InTouch Newsletter – September 2015

TOPRA BOARD ELECTIONS: VOTE ONLINE BY 5 OCTOBER 2015

IT’S TIME TO CAST YOUR VOTE

ALL VOTES MUST BE RECEIVED ONLINE BY 6PM UK TIME ON MONDAY 5 OCTOBER 2015

There has been a great response to our call for nominations to the TOPRA Board for 2016, and we are pleased to announce that by the deadline two nominations were received for the position of President-Elect, and eight for the four vacant Director positions.

The full list of candidates can be seen below along with their nominators. Members will be asked to select one candidate for President-Elect and up to four candidates for the Director positions. We ask that members consider all of the candidates for each role individually, and vote for the person who they feel would be best suited in these important roles for TOPRA.

In order to help you make your selection, the candidates have provided a brief summary of their intentions in standing for election. These can be viewed on the TOPRA website by visiting www.topra.org/board-elections.

It is now time for the whole membership to play their part. We invite ALL current and paid-up Members, Registered Members and Fellows (including those who are retired) to be part of the decision-making and to cast their votes by visiting www.topra.org/voting.

Please note that Honorary Life Members and Student Members are not eligible to vote.

All votes must be received online by 6pm UK time on Monday 5 October 2015.

The results

The results of the Election will be announced at the TOPRA Annual Review Meeting on 13 October 2015, which will be held during the Annual Symposium in Berlin.

Michel Mikhail

Mariam Aslam Lena Björk Will Drury

Aileen Fisher Sharon Gorman Carlos Langezaal

Robert Clay Angela Stokes

Andrew Whiles

POSITION NOMINEE PROPOSER SECONDER (1) SECONDER (2)PRESIDENT-ELECT Robert Clay Thomas Kühler Zubair Hussain Carlos Langezaal

PRESIDENT-ELECT Angela Stokes Sue Harris Eva Kopecna Sarah Roberts

DIRECTOR Mariam Aslam Anusha Bala Raveesh Nayar David Sapp

DIRECTOR Lena Björk Thomas Kühler Anita Finne Grahnén Anders Neil

DIRECTOR Will Drury Sally John Sarah Roberts Thomas Kühler

DIRECTOR Aileen Fisher Bob Clay Graham Higson Colin Vickers

DIRECTOR Sharon Gorman Nick Sykes Stuart Comlay Sylvia Lobo

DIRECTOR Carlos Langezaal Chris Griffett Alix Alderman Olga Alfieri

DIRECTOR Michel Mikhail Zubair Hussain Miranda Pothiawala Stella Koukaki

DIRECTOR Andrew Whiles Michael Fenster Aine Kane Anthony Barker

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA InTouch Newsletter – September 2015

AWARDS FOR REGULATORY EXCELLENCE 2015

TOPRA is pleased to announce the shortlisted nominees for the Awards for Regulatory Excellence, following careful consideration of all entries by our prestigious panel of judges. This year’s ceremony will be held at the Royal College of Obstetrics and Gynaecology on 18 November 2015

THE SHORTLISTS

BOOKING NOW OPEN! Please visit www.regulatoryaffairsawards/book to secure your place

CONTRIBUTION Aileen Fisher, VP Global Regulatory Affairs, CMC and Publishing, Kinapse, UKTorkil Fredborg, Principal Regulatory Advisor, Eli Lilly, UKRobin Henderson, Director, Regulatory Affairs, Alan Boyd Consultants, UKAngela Stokes, Senior Director Regulatory Affairs, Chiltern International, UK

FUTURES Advanced Therapies Forum Regulatory Team, PPD, representatives from Belgium, Germany, Sweden, UK and USAlexis Cockroft, Biopharm CMC Regulatory Affairs, GlaxoSmithKline, UKMaureen Graham, Managing Director, Diamond BioPharm, UK Lindsay Ham, Global Neuroscience Franchise Head, Regulatory Affairs, Roche, Switzerland

INNOVATION Sabine Atzor, Head of EU Regulatory Policies, Roche, Switzerland and Director Regulatory Affairs, EFPIA (secondment), BelgiumAnna Nightingale, Michelle Riddalls and Kate Stockman, Pfizer Nexium GSL, Pfizer Consumer Healthcare, UK Thomson Reuters Cortellis Regulatory Intelligence, Thomson Reuters, France

EDUCATION Detlef Hold, Nathalie Schultze and Elke Sims, The Roche Global Regulatory Leader Pipeline Programme, Roche, US and SwitzerlandMargareth Jorvid, Regulatory Consultant, Methra Uppsala AB and Senior Partner, LSM Group, SwedenCarlos Langezaal, Director, Global Regulatory Affairs, Eisai, USLloyd Stevens, Early Clinical, A Pharmaceutical Consultancy, UK

HORIZON Kirsty Cotton, Senior Regulatory Affairs Executive, TRAC Services, UKChloé Garay, Senior Regulatory Associate, Eli Lilly, UK Françoise Van Eenoo, Regulatory Affairs Officer, Quintiles, Belgium

INSPIRATION Michael Banks, Senior Vice President Regulatory Affairs, Teva Pharmaceuticals, UKJames Hall, Chief Regulatory Officer, JensonR+, UKFlorence Houn, Vice President Global Regulatory Intelligence Policy and Strategy (Retired), Celgene, US Leyla Lister (Head of Emerging and Regional Affiliates) and Marta Parmar (Head of International Product Support), Roche, Switzerland

SUPPORT Kinapse Merck Regulatory Team, UK and USPPD RegView, PPD, USTRAC Services, UKValerie Codrons and Regulatory Affairs Team, Quintiles Global Regulatory Affairs, Belgium

THANK YOU to our Awards Sponsors! TOPRA is grateful to our sponsors for their support in rewarding excellence in regulatory affairs.

INNOVATION FUTURES CHAMPIONS

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA InTouch Newsletter – September 2015

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.

In-House EditorRachel Cook

Co-Editors Greer Deal, Ishbel MacDonald and Graeme Ladds

PublisherJenine Willis

How to contact InTouchIf 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/intouchViews 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.© 2015 The Organisation for Professionals in Regulatory Affairs

TOPRA6th Floor 3 Harbour Exchange South Quay London E14 9GETel: +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 £190. TOPRA members can read or download InTouch online at www.topra.org

Mr Sam Bovonsombat, Regulatory Affairs Analyst, Allergan, Marlow, UK

Ms Aghogho Ogunlesi, Regulatory Affairs Associate, Chiltern International, Edinburgh, UK

Ms Sophie Totten, ClinTec International, Glasgow, UK

Ms Leigh Fell, ClinTec International, Glasgow, UK

Ms Ramona Pittarello, Sales Rep & Technical Consultant Medtronic, Medtronic BioPharma, Torino, Italy

Mr Yousif Elhaty, Regulatory

NEWTOPRAMEMBERSTOPRA welcomes the following new members who joined recently

*Registered Member

Affair Manager, Valeant Pharmaceuticals, Sharjah, UAE

Mr Fahd Azzabi, Quality Control Supervisor, CHUV, Lausanne, Switzerland (Student)

Mrs Yulia Maslova, Regulatory Affairs Manager, PRA Health Sciences, Moscow, Russia

Dr Lisa Matzen, Gau-Algesheim, Germany

Mrs Peggy Cance, Senior Regulatory Affairs Consultant, Blue-Reg Pharma, Sophia Antipolis, France

Ms Sini Eskola, Regulatory Affairs Director, EFPIA, Brussels, Belgium

Miss Donna Kaye Robinson, R&D Info Systems Analyst I, Gilead, Cambridge, UK

Mr Donald Palmer, Director, Product Strategy & Regulatory Informatics, Acuta, Yardley, US

Ms Yumiko Asano, Associate Director Regulatory Affairs, Chugai Pharma, London, UK

Miss Claudia Bellomo, Uppsala University, Uppsala, Sweden (Student)

Miss Carly Bedwell, Regulatory Affairs Officer, Quintiles, London, UK

Mr Sriharsha Myneni, Regulatory Affairs Officer, Quintiles, East Ham, UK

Mrs Nicola Brookbanks, Regulatory Affairs Associate, Novella Clinical, Stevenage, UK

Dr Micaela Rocco, Associate Consultant, Parexel International, London, UK

Mrs Emma Lambert, Regulatory Affairs Associate II, Gilead Cambridge, UK

(L-R) Sophie Brand (Senior RA Executive), Sarah Trethowan (Operations Director), Graham Donaldson (RA Project Manager), Jonathan Trethowan (Commercial Director) and Claire Pomeroy (RA Manager).

CELEBRATING ‘TIN’ YEARS EU Regulatory Affairs consultancy, TRAC Services, has recently celebrated not one, but three employees’ 10–year anniversaries

year employees. They’ve brought an outstanding contribution to the company and truly helped us get to where we are now.”

Graham, Claire and Sophie have been TOPRA members since joining TRAC and are all proactively involved in our professional body. Contributions include encouraging more graduates to choose regulatory affairs, helping plan and deliver events and training such as the introductory course and TOPRA Awards ceremony; and as members of TOPRA committees such as the Professionalism Committee.

Graham Donaldson, Sophie Brand and Claire Pomeroy all joined TRAC Services in late 2005, as the company’s first employees. They will be celebrating a ‘tin’ anniversary with the company after ten years of service. TRAC was created in 2001 by company directors Jonathan and Sarah Trethowan, and is based in Redruth, Cornwall.

“I remember starting like it was yesterday” said Graham Donaldson, Regulatory Affairs Project Manager, “I’ve seen the company grow and it’s been amazing to be part of that journey.”

Claire Pomeroy, Regulatory Affairs Manager said: “We joined TRAC when it was taking those first steps of expansion and now it’s evolved into a successful business with fantastic people, knowledge and skills.”

Company Director Jonathan Trethowan said, “Has it really been 10 years? I’m very impressed and proud of all the achievements of our 10– David Callaghan, TRAC Services

Team TOPRoar!Past and present TOPRA staff members Stevie Moore, Rachel Cook, Vincent Costello and Emma McNeely completed the 10k ZSL London Zoo Stampede on 20 September.

Over 500 runners took part in the race through London Zoo and Regent’s Park, raising money for the Asiatic Lions Campaign.

Team TOPRoar were the sixth team to cross the finish line!