Welcome to our new home AWARDS VENUE ANNOUNCED

April 2015
THE TOPRA NEWSLETTER – KEEPING MEMBERS IN TOUCH
In this issue...
TOPRA’s new office is
exciting news this month,
and has been long in the
planning. With better
facilities and location for
our members, it is clear
that TOPRA has a firm
future ahead (see page 2).
This month we would
also like to remind
members of the benefits
that joining one of our
TOPRA Communities can
bring (see page 3). Giving
you the opportunity to
share your professional
expertise with – and gain
knowledge from – your
colleagues and peers, it is
a great way to get the most
out of your membership.
Graeme Ladds
Director, PharSafer
Co-Editor, InTouch
Welcome to our new home
SARAH ROBERTS, TOPRA PRESIDENT
TOPRA’s big news this month is the announcement of
the office move to Harbour Exchange, South Quay – a
relocation which has been a long time in the making!
The TOPRA Board has been
discussing the various options
for our new home for at least
two years. During that time a
number of different premises in
a variety of locations have been
considered.
Each option had many pros
and cons which needed to be
weighed up to benefit both the
needs of the organisation and
its members, as well as the
current and future economic
environment (see page 2).
Harbour Exchange offers
many advantages in terms
of location (it is closer to the
EMA with great access to
Canary Wharf and South Quay
stations), but also has flexible
meeting rooms so that TOPRA
can continue to run some of its
educational offerings ‘in-house’
and of course continue to host
regular Working Party meetings.
Perhaps most importantly, the
new building offers us long-term
security as we have negotiated a
very competitive 10-year lease.
A big thank you to the TOPRA
office team for ensuring a very
quick and efficient move, with a
special mention to Loretta Brown
(Facilities Manager at TOPRA)
for her outstanding efforts in
making sure that the new office
was fitted out to a great standard
and ready for the move.
In the January and February
2015 issues of InTouch we
showcased some testimonials
from our graduates of the MSc
in Regulatory Affairs, now
validated by the University of
Hertfordshire.
Some of the comments made
in the testimonials struck a chord
for me, and it is great to see such
commitment to our profession.
Creating a solid foundation of
regulatory knowledge, focusing
on career progression and
improving transferrable skills
such as strategic thinking are all
important factors in building a
successful career.
The MSc course welcomes
new participants and more
information can be found
on the TOPRA website or by
contacting [email protected].
Finally, you may have seen
our recent notifications that
nominations are now open
for the Awards for Regulatory
Excellence 2015. To view
the category criteria in full
and to request nomination
forms please visit www.
regulatoryaffairsawards.org.
This is a prestigious
annual event, but it is of
course reliant on receiving
high quality nominations for
each of the categories. If you
would like to discuss which
category would best suit your
nominee, or to find out more
information about completing
the nomination form, please
contact the TOPRA team at
[email protected] who will be
happy to help!
AWARDS VENUE ANNOUNCED
The 2015 Awards for Regulatory Excellence will be presented at the
Royal College of Obstetrics and Gynaecology, London on 18 November
The College was founded in 1929 with a mission to set standards to improve women’s
healthcare worldwide. It is therefore the perfect venue for our Awards, which celebrate
the contribution of regulatory affairs to safe and effective healthcare.
Please put the date in your diary and look out for more Awards information soon!
INNOVATION
FUTURES
CHAMPIONS
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
PAEDIATRIC LEGISLATION CONFERENCE, 20 MARCH, LONDON
ARE WE MEETING THE CHALLENGE?
Delegates from seven EU member states and the US gathered together last month to discuss the impact of EU paediatric
regulation on drug development and regulatory strategy
Paolo Tomasi, Head of Paediatric Medicines at the European
Medicines Agency (EMA) began proceedings by presenting an
overview of the EU regulatory landscape in this area since the new
regulation was introduced in 2007.
This was followed by a summary of how industry has adapted
to these changes, outlined by Anthony Compton of Pfizer (Director,
Worldwide Safety and Regulatory, Global Innovative Pharma
Business). Pamela Dicks (Manager, Scottish Children’s Research
Network) also discussed how patient groups have worked with the
new regulation.
The session was later split into three separate workshops
(pictured above) to widen the debate, focusing on the following
paediatric topics:
•Workshop 1: Practical challenges with Paediatric Investigation
Plans (PIPs), led by Anthony Compton
•Workshop 2: Global development challenges, led by Jill Challis
(NDA) and Dirk Mentzer (Chair of the Paediatric Committee)
•Workshop 3: Paediatric networks and their place in challenges
associated with the conduct of studies in paediatrics, led by
Pamela Dicks with support from Irmgard Eichler (Co-Chair of
Enpr-EMA (European Network of Paediatric Research at the
EMA)).
The day was rounded off with a panel session aided by Jordi
Llinares-Garcia, Head of Department of Product Development
Scientific Support at the EMA. A full report of the lively discussion
which followed will appear in Regulatory Rapporteur in the coming
months.
TOPRA also announced the launch of an online course on EU
paediatrics legislation, including topics such as developing a PIP.
Module 1 is available now: www.topra.org/online_paediatrics.
TOPRA has moved!
The TOPRA office moved on 13 April, and our new address is:
TOPRA
6th Floor
3 Harbour Exchange
South Quay
London E14 9GE
Better facilities, better location
©LifeTrain
There are substantial advantages to the new offices which help secure
TOPRA’s long-term future. We have a 10 year lease, meaning TOPRA has
a stable home in our preferred location.
With a Boardroom and separate meeting room we will be able to
host more TOPRA courses and meetings in-house. TOPRA members will
also be able to make use of these facilities for their own meetings at
preferential rates.
The move takes us closer to EMA headquarters, and is just next to
South Quay DLR station and an easy walk from the Jubilee Line at
Canary Wharf.
We hope to see you at the new office soon!
Please note that our telephone numbers and email addresses remain the same.
TOPRA InTouch Newsletter – April 2015
TOPRA InTouch Newsletter – April 2015
TOPRA COMMUNITIES:
INs AND SPINs
As a TOPRA member you have access to a wealth of networking and discussion opportunities to
share your expertise and in turn benefit your professional development
You might be interested in joining one of the ever-growing number of TOPRA In groups facilitating meetings in
individual countries. Alternatively, if you have a specific area of interest – from biotechnology through to clinical
trials – then joining one of the TOPRA Special Interest Networks (SPINs) may be for you.
With the recent launch of the new member engagement service, you can now manage your groups under the
‘My communities’ tab on the TOPRA website. This will enable you to share in discussion that is relevant to your
professional interests, and will ensure that you get the most out of your TOPRA membership. Join a TOPRA
Community today or contact membership @topra.org for more information.
How do TOPRA Communities work?
TOPRA In groups
Special Interest
Networks (SPINs)
Our TOPRA In groups support regulatory professionals living and working
in a particular country or region, providing a relevant and focused forum
for discussion and networking.
There are currently nine active groups operating in the following
countries:
•Austria
• France
• Ireland
•Italy
• North America • Scotland
• Spain
• Sweden
• Switzerland
TOPRA SPIN groups promote contact between regulatory professionals
working in the same specialist sector, encouraging the exchange of views
and ideas.
They are also a useful channel for TOPRA to ensure that the needs of
these sectors are taken into account in the planning stages of the TOPRA
training programme, along with gaining expert input into its content.
The following SPINs are available for all TOPRA members:
• Biotechnology • Medical Technologies • Regulatory Intelligence
• CMC
• Veterinary
• Japan
• eRA
• Pharmacovigilance
• Clinical Trials
• Young Regulatory
Professionals
TOPRA IN UPDATE
TOPRA In Italy
Dr Antonia Orsi, Chair of TOPRA
In Italy and Director, Salupont
Consulting Ltd
TOPRA In Italy was formed in 2012, intended to
provide Italian members with the opportunity to
come together and discuss different perspectives in
regulatory affairs, make new contacts and help with
daily regulatory work in the healthcare sector.
I have been the Chair of this group since its
inception and I am delighted with the progress it
has made; thank you to its active Working Party for
their help! We have already organised two successful
events in 2015, the first to discuss ‘Falsified
Medicines in Italy and Europe’ and the second on
‘Clinical Stem Cell Research: a review of recent
regulatory updates and Italian activities’. We are now
preparing for further interesting meetings, including
a session on ‘Adaptive Pathways’ (21 April) and the
‘Escher Project’ (19 May).
Do not hesitate to contact me (aorsi@
salupontconsulting.com) if you have any questions
about TOPRA In Italy or would like to join the group –
I look forward to welcoming you at our next meeting!
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
TOPRA InTouch Newsletter – April 2015
Career opportunity at TOPRA
In-House Editor
Rachel Cook
TOPRA is looking to appoint a senior regulatory professional to join the team as
Director of Policy in our new offices in the Canary Wharf area of London
Co-Editors
What is the role? This new role will be responsible
for taking forward strategies to develop
increasing professionalism for those working in
regulatory roles, and to ensure that TOPRA has
the structures, tools and resources to support
members in achieving professional recognition.
The Director of Policy will have oversight of the
evolution of membership and education activities
within the organisation, and also an important
role in building and maintaining our key external
relationships.
Publisher
Who do we want? You will be an experienced
regulatory practitioner, perhaps with a policy
or regulatory intelligence background. You will
have an appreciation of how TOPRA works, an
understanding of the importance of professional
development and a commitment to furthering
regulatory excellence.
Your track record will demonstrate an ability
to manage change and achieve consensus
with excellent oral and written communication
skills. An interest in developing a career in the
association sector is crucial.
Interested? If you would like to learn more please
contact Lynda Wight ([email protected]) to request
a full position description or to talk about the role
in confidence.
Closing date: Tuesday 12 May
NEWTOPRAMEMBERS
TOPRA welcomes the following new members who joined recently
Mr Vladimir Obradovic,
Regulatory Officer, Pfizer,
Belgrade, Serbia and
Montenegro*
Mrs Julie Raybould, Search
& Selection Consultant, TM
Recruit, Berkhamsted, UK
Dr Katarina Alheim, RA
Manager, NordicInfu Care,
Nacka Strand, Sweden*
Dr Aisling Frizzell, RA
Specialist, Merck Sharp and
Dohme, Hoddesdon, UK*
Dassault Systemes, Velizy
Villacoublay, France
Mr Yann d’Aramon, Sales
Director Life Sciences,
Dassault Systemes, Velizy
Villacoublay, France
Dr Dinesh Mistry, Director
Global Regulatory Strategy,
Covance Clinical and
Periapproval Services,
Maidenhead, UK*
Mrs Vi Stuart, RA Director,
Retroscreen, London, UK*
Mr Etienne Daher, Joseph
Fourier University, Grenoble,
France (Student)
Miss Victoria Stead, RA
Manager, Mölnlycke Health
Care, Lance, UK
Mrs Kirsten Van Garsse, RA
Manager, Tosoh Europe NV,
Tessenderlo, Belgium
Ms Zahrah Chaudhary, RA
Assistant, Mölnlycke Health
Care, Lance, UK
Miss Rabiea Abdullah,
Pharmaceutical Assessor,
MHRA, Luton, UK*
Ms Elizabeth Rimmer, QRS,
Ipsen, Warrington, UK
Miss Hayley Colleran, RA
Administrator, Pharmalink
Consulting, High Wycombe,
UK
Miss Ligita Montvilaite,
Queen Mary, University of
London, UK (Student)
Dr Raheleh Ahmadi, RA
Associate, GlaxoSmithKline,
London, UK
Ms Michelle Ortiz, Associate
Director ROW LATAM, Gilead,
Great Abington, UK*
Mr Stephen Tavares,
Principal, Philosophy IB,
Florham Park, US
Mr Alban Van Landeghen,
Senior Business Consultant,
Mr Phil Ross, RA Specialist,
Mölnlycke Health Care,
Bolton, UK
Dr Stuart Beattie, Regulatory
Product Development
Manager, Diamond BioPharm,
Harlow, UK
Miss Eesha Vyas, RA
Associate, GlaxoSmithKline,
Bracknell, UK*
Mr Tristan Maguet, St Ismier,
France (Student)
Mr Ian Love, Site Regulatory
Officer, Sanofi, Bishops
Stortford, UK*
Mrs Margarita Rodriguez
Espinoza, RA Specialist,
Novartis Animal Health,
Basel, Switzerland*
Mrs Samantha Marshall,
RA Manager EMEA & APAC,
Ansell Healthcare, Tamworth,
UK*
Ms Paula Martinez,
Biologiclas RA Manager,
Laboratorios Ovejero SA,
Carbajal de la Legua, Spain*
Ms Kathleen Harris,
Managing Director, 2Harris
Consulting, Market Drayton,
UK
Miss Aparajitha Ganapathi,
Oxford, UK*
Miss Melissa Griffith,
Hounslow, UK (Student)
Ms Judit Dunbar, Officer,
Basel, Switzerland
Miss Fatima Naseer, Preregistration Pharmacist,
General Pharmaceutical
Council, London, UK
(Student)*
Dr Silvia Stingele, RA
Executive, Regulis Consulting,
Tring, UK*
Dr Hilde Depraetere, Senior
Consultant RA, Eudrac, MEM,
MTOPRA, Eberbach, Germany
Ms Safina Arif, Regulatory
Consultant, Parexel,
Uxbridge, UK
Ms Elena Hermida, Senior
RA Specialist, PPD, Madrid,
Spain
Ms Jacquelyn Awigena-Cook,
Associate Director, Head
of PV Policy, Johnson and
Johnson, High Wycombe, UK
Mr James Shearn, UK RA
Manager, Abbott Diabetes
Care, Witney, UK
Ms Anne-Marie Turner,
Regulatory Associate, Reckitt
Benckiser, Hull, UK
Ms Sandrine Couturier,
Manager, Celgene, Uxbridge,
UK
Ms Charlotte Vergara,
Associate Manager, Celgene,
Uxbridge, UK
Dr Laurie Bertrand, Actelion
Pharmaceuticals, Allschwil,
Switzerland
Greer Deal, Ishbel MacDonald
and Graeme Ladds
Jenine Willis
How to contact InTouch
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
3 Harbour Exchange
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
Mrs Sue Scott, Quality
Regulatory Specialist, Ipsen,
Nantwich, UK*
Mr Martin Kretz, RA Manager,
Vifor, Glattbrugg, Switzerland
Mr Jonathan Archer, Director
and Hub Lead EU/ANZ, EME &
AFME, Pfizer, Minster, UK*
Mr Jay Vora, Pharmacist,
Leicester, UK*
Dr Graeme Deuchar, RA
Manager, Kinesys Consulting,
Glasgow, UK
Miss Raluca-Elena Enuta,
ISPB Lyon, Vaulx-en-Velin,
France (Student)
Ms Emma Blasi, RA Manager,
VCN Biosciences, Sant Cugat
Del Valles, Spain
Dr John Smart, Director
Reg CMC, AstraZeneca,
Macclesfield, UK
Mrs Roza Stevens, Project
Manager, Forest Laboratories,
Dartford, 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