Symposium success! CELEBRATE IN STYLE

October 2015
THE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCH
In this issue...
Autumn usually feels
like the start of a new
term to me and this year
is no different: TOPRA
welcomes seven new
Fellows and announces
the new Board of
Directors who will take
office from January 2016.
Congratulations to them
all!
On the subject of
congratulations, there
is an exciting line-up
of entries in this year’s
Awards for Regulatory
Excellence. Why not join
in the celebrations and
raise awareness of the
amazing achievements of
regulatory professionals
throughout the global life
science sector. You never
know – in the future a
TOPRA Award could be
yours!
Greer Deal
Director, Global Regulatory
Services
Co-Editor, InTouch
Symposium success!
SARAH ROBERTS, TOPRA PRESIDENT
I am delighted to have heard very positive feedback about the 12th
TOPRA Annual Symposium in Berlin. A company meeting in the US
meant that I was unable to attend, but social media posts confirm
that a good time was had both at the conference and in Berlin!
I would like to take the opportunity
to thank the Symposium
Working Party for organising a
superb programme and great
opportunities for networking. This
is no mean feat and takes a huge
amount of hard work both prior to
and during the event itself. Thank
you to all!
For me personally, it was
strange not to be preparing a
session report or two for the
Regulatory Rapporteur on the
plane home, but I know the
editorial panel were there in force
and I look forward to reading the
reports in the next issue.
During the Annual Review
Meeting held at the Symposium,
Past-President Jonathan Trethowan
described the progress we had
made on the strategy set for
TOPRA. This highlighted the
progress on digital services,
(including the new member
engagement system and increase
in e-learning resources), on
partnerships we have forged and of
course the establishment of a new
‘home’ for TOPRA in our offices in
South Quay.
The newly published Annual
Report for 2014–15 includes a
full update of everything we have
achieved during the last year
with the help of our members
and volunteers, and includes a
summary of the positive financial
results for 2014. The Annual
Report has been circulated to all
members electronically: if you
have not spotted it in your packed
inbox please let the office know!
I urge you to read it: it is one
way in which the Board, which is
answerable to you as members,
can make sure you are fully
informed of everything happening
in your organisation.
The results of the TOPRA
Board Elections have now been
announced (see page 2). I would
like to congratulate our new Board
members and thank all of the
candidates who put themselves
forward for election – and of
course to everyone who voted. I
very much look forward to working
as part of the 2016 TOPRA Board
under the leadership of Thomas
Kühler.
With only a few weeks until
the Awards for Regulatory
Excellence, now is the time to
book your tickets (see below). I
would personally like to wish all
the shortlisted nominees every
success and look forward to an
evening of celebrating excellence
within our profession.
Finally, next week after
6 months of maternity leave,
I return to work. I have been
thinking about which, if any,
of my new-found transferable
skills may be relevant in the
workplace. I have to admit I am
struggling to position knowing
the words to over 50 nursery
rhymes into the mix – but you
never know! On a more serious
note, it has given me a new
appreciation of the importance
of the necessity of developing
medicines for paediatric use,
with all that entails.
CELEBRATE IN STYLE
Last chance to book your tickets for the Awards for Regulatory Excellence!
This year’s glittering ceremony will take place at the Royal College of Obstetricians and
Gynaecologists in Regent’s Park, London on 18 November. A record number of entries were
received this year and the Shortlists have been announced – it is now your chance to join us in
celebrating regulatory excellence!
BOOK NOW – Visit www.topra.org/awards15 for details and to book your seat.
INNOVATION
FUTURES
CHAMPIONS
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
A WARM WELCOME TO OUR NEW
TOPRA FELLOWS
Paul Cooper, Assentra
Nicola Hardman,
JensonR+
Vimal Patel, Reckitt
Benckiser
Davina Stevenson,
Gilead Sciences
We are thrilled to welcome seven new Fellows to our organisation this month:
Paul Cooper, Nicola Hardman, Vimal Patel, Davina Stevenson, Nick Sykes, Eszter
Teleki and Chris Walker
Paul Cooper was introduced to regulatory affairs at the start of his career in
industry in 1984, and since 2012 has continued through Assentra, his own
independent consultancy company. He has been Chair of the TOPRA Veterinary
SPIN group and the Veterinary Variations CRED training since 2013.
Nicola Hardman has 17 years of pharmaceutical industry experience, with
15 of those gained continuously in the regulatory field. Nicola has worked as a
regulatory consultant in JensonR+ since 2009, and has contributed articles on
topics including biopharmaceutical manufacturing to the Regulatory Rapporteur.
Vimal Patel has worked in regulatory affairs for 18 years, and is currently Head
of Global Compliance Projects at Reckitt Benckiser. Since 2009 Vimal has made
significant contribution to the TOPRA CRED CMC course, and as a member of the
TOPRA Professionalism Committee has helped to develop the CPD programme.
Davina Stevenson has worked in regulatory and pharmaceuticals for 16 years
and is currently Associate Director Regulatory Affairs, Liver Disease at Gilead
Sciences. She has been a member of the TOPRA Regulatory Rapporteur Editorial
Board since 2010, and wrote The TOPRA Guide to Regulatory Intelligence (2012).
Nick Sykes has been working in regulatory since joining SmithKline
Beecham in 1992 as part of their Regulatory Intelligence team. He is currently
a Senior Director at Pfizer, and Nick speaks regularly at the TOPRA Spring
Introductory Course and the Annual Symposium.
Eszter Teleki is a medical doctor by training, with 20 years of
pharmaceutical and regulatory experience. She has spoken at a number of
international meetings and conferences and was one of the co-founders of the
Hungarian Regulatory Affairs Professional Society (HURAS).
Chris Walker joined the regulatory profession in 1996 at Bio Products
Laboratories (BPL), and has since been based at Amgen. He completed the
TOPRA MSc in 2002, and has since spoken at the Introductory Course. Chris is
an active member of a number of trade association committees.
Nick Sykes, Pfizer
Eszter Teleki, BristolMyers Squibb
Chris Walker, Amgen
Thank you for choosing our new Board members
TOPRA announced the new Board of Directors at the Annual Review Meeting in Berlin on 13 October, appointed
after a well-supported election process
The successful candidate for President-Elect was Robert (Bob) Clay, Chief Regulatory Officer at Kinapse and Director of
Highbury Regulatory Science. Along with Bob, four new Directors were appointed at the meeting and are all due to take office
from January 2016. The new
Directors will be Lena Björk
(Director of Supervision, Medical
Products Agency), Will Drury
(Senior Business Associate,
Cyton Biosciences), Aileen Fisher
(VP Regulatory Affairs, Kinapse)
and Sharon Gorman (Director EU
Bob Clay
Lena Björk
Will Drury
Aileen Fisher
Sharon Gorman
Regulatory Policy, Pfizer).
TOPRA InTouch Newsletter – October 2015
TOPRA InTouch Newsletter – October 2015
12 TH TOPRA ANNUAL SYMPOSIUM
Highlights from Berlin
TOPRA’s Annual Symposium – a key event in the regulatory calendar – took place on
TOPRA is pleased to announce the shortlisted nominees for the Awards for Regulatory Excellence,
12–14 October in Berlin, Germany. This year’s conference was held in conjunction with the Federal Institute
following careful consideration of all entries by our prestigious panel of judges. This year’s
for ceremony
Drugs and will
Medical
Devices (BfArM) and the Federal Office of Consumer Protection and Food Safety (BVL).
be held at the Royal College of Obstetrics and Gynaecology on 18 November 2015
1
2
3
4
5
1. Prof. Dr. med. Karl Broich, President of
BfArM in Germany, opened this year’s
Symposium by presenting the fourth
TOPRA Annual Lecture on the subject of
‘Next Generation Sequencing’.
2.More than 400 delegates attended the
three-day conference, held this year at
the Maritim proArte Hotel in Berlin.
6
7
3.(L–R) TOPRA Executive Director Lynda
Wight with Birka Lehmann, Head of Unit
at BfArM, Karl Broich, President of BfArM
and Christine Mayer-Nicolai, Senior
Director, Head Europe Global Regulatory
& Scientific Policy, Merck Serono.
4.Congratulations to Sandra NavarroCarrasco from Hibernia College, Ireland,
who won first prize in the Student Poster
Competition.
8
9
5. Celebrations were also in order for
this year’s ‘TOP Team’, presented to
Margareth Jorvid on behalf of TOPRA In
Sweden.
6.A delighted Melanie Leivers, Working
Party Member for the Veterinary
Symposium, received the Distinguished
Service Award for her valued
contribution to TOPRA.
10
11
7/8. The Exhibition Hall was a hive of
activity with almost 30 market-leading
exhibitors in attendance spanning
translation, recruitment, consultancy
and more!
9/10.The German themed Symposium
Networking Dinner was the perfect
close to a busy first day of sessions,
and delegates were treated to musical
entertainment by the ‘Berlin Trio’.
11.TOPRA President-Elect Thomas Kühler
looked to the future of TOPRA in the 2015
Annual Review Meeting.
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
TOPRA InTouch Newsletter – October 2015
Diamond BioPharm
hits the big 10!
This October, Diamond BioPharm celebrates
10 years of supporting the pharmaceutical
and biotech industry. Company founder and
TOPRA Fellow Maureen Graham reflects on
the highlights of the last decade...
In October 2005 the doors opened to Diamond
BioPharm, a regulatory affairs consulting
organisation. Making the decision to move away
from the security of working for a pharmaceutical
company and starting a business was scary, to say
the least – but it had to be done!
Before stepping out alone, I gained extensive
regulatory and development experience across
many product types and from major multi-nationals
such as Amgen, Merck Sharp and Dohme, Ivax (now
Teva) and Glaxo.
I knew I wanted to continue to work with people
around me and not on my own, so I started out in
a serviced office with an administrative colleague.
Over the 10 years, the organisation has grown and
currently employs around 20 people across the UK
and US. I cannot mention them all here, but they are
a fabulous, strong team!
Since the company was founded a number
In-House Editor
Rachel Cook
Co-Editors
Greer Deal, Ishbel MacDonald
and Graeme Ladds
Publisher
Jenine Willis
How to contact InTouch
The Diamond BioPharm team celebrate their 10th anniversary
this month, led by Company Director Maureen Graham (front
row, 4th left).
of challenges have presented themselves to the
pharmaceutical and biotech industry. Diamond
BioPharm has sought to overcome these for our
clients in order to ensure regulatory challenges and
changes are met with innovation and compliance.
Our team is able to draw on a wealth of
experience, and we continue to look to provide
services that offer maximum value to our clients
in the most efficient and cost-effective manner.
The hard work of the Diamond team was recently
reflected in them winning the Innovation Category
in the TOPRA Awards for Regulatory Excellence in
2013.
The hardest thing in starting a business
was choosing the name – but, for my ex-Amgen
colleagues, it had to feature Diamonds!
NEWTOPRAMEMBERS
TOPRA welcomes the following new members who joined recently
Miss Claire Starr, Regulatory
Operations Associate II,
Gilead Sciences, Great
Abington, UK*
Ms Barbara Lachmann,
Labelling Consulting,
Hofheim, Germany*
Mrs Priya Vasudeva,
Regulatory Affairs Officer,
London, UK
Miss Sarah Laird, Regulatory
Affairs Associate, Reckitt
Benckiser, London, UK*
Ms Ida Sophie Grew,
Regulatory Affairs
Professional, Novo Nordisk,
Soeborg, Denmark
Mr Viren Bhatia, Pharmacist,
Tudor Pharmacy,
Northampton, UK
Mrs Abigail Matthews, Safety
Reporting Specialist, Novella
Clinical, Norwich, UK
Dr Anne-Marie McNicol,
Regulatory Specialist, Novella
Clinical, Stevenage, UK
Miss Adesola Alade,
Regulatory Safety
Associate, Novella Clinical,
Hertfordshire, UK
Dr April Marquick, Regulatory
Affairs Associate, Novella
Clinical, Hertfordshire, UK
Mr Farhad Salam, Regulatory
Affairs Associate, Novella
Clinical, Hertfordshire, UK
Miss Mariya Petkova,
University of Aberdeen, UK
(Student)
Miss Anita Chiverton,
Harborne, UK (Student)
Miss Caroline Haegeman,
London, UK (Student)
Mr Mehraj Ahmed, Kings
College London, St Ives, UK
(Student)
Miss Laura Maginley, Kings
Langley, UK (Student)
Mr Robbie McCann, Head
of Quality & Reg Affairs,
Tangerine Holdings, Preston,
UK*
Mr Bhagwant Ubhi, Senior
Regulatory Affairs Manager,
Pfizer Consumer Healthcare,
Oakville, Canada*
Miss Helene Deconinck, UCL
School of Pharmacy, London,
UK (Student)
Mr Seth Cunningham, Wells,
UK (Student)
Mr Arnór Jonsson, Global
Regulatory Affairs Associate,
Ferring Pharmaceuticals,
Copenhagen, Denmark*
Mrs Keral Patel, Regulatory
Affairs Officer, Merck Sharp &
Dohme, Hoddesdon, UK*
Ms Lilya Winterton, Pfizer
Consumer Healthcare,
Tadworth, UK
Miss Sarah Robertson,
Regulatory Affairs Specialist,
Endo Ventures, Ballsbridge,
Ireland
Dr Ralf Herbold, Head
of RA Emerging Markets
Biosimilars, Boehringer
Ingelheim Pharma, Frankfurt,
Germany
Mr Luke Cunlisse, University
of Leeds, Wigan, UK (Student)
Mr Daniel Lewis, University
of Hertfordshire, Baldock, UK
(Student)
Dr Haven McCall, Vice
President Regulatory Affairs,
Megadyne Medical Products,
Draper, US
Dr Nonna Holpné Kozlova,
Senior Regulatory Consultant,
Reginfo, Pest, Hungary*
Ms Marie-Claire GatineauChazal, Regulatory Operations
Associate, EUSA Pharma,
Lyon, France
If you would like to contribute
to the newsletter, or find
out about deadlines, please
contact Rachel Cook
([email protected]).
Please address any articles
and correspondence to:
[email protected] 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.
© 2015 The Organisation
for Professionals in
Regulatory Affairs
TOPRA
6th Floor
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South Quay
London E14 9GE
Tel:+44 (0) 20 7510 2560
Fax:+44 (0) 20 7537 2003
E-mail: [email protected]
InTouch is free to TOPRA
members. Annual
membership of TOPRA is
£190. TOPRA members can
read or download InTouch
online at www.topra.org
Mrs Sonal Patil, Regulatory
Affairs, Medreich, Feltham,
UK*
Ms Eduarda Batista, EU
Strategist, Pfizer, Tadworth,
UK*
Mr Mark Roessel, Vice
President, Concert
Pharmaceuticals, Lexington,
US
Miss Katharine Miller,
Lead Associate, Genpact
Pharmalink, Maidenhead, UK
Dr Fiona McMonagle, RA
Executive, Wockhardt,
Wrexham, UK*
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.
*Registered Member
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION