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ASSOCIATION OF THE EUROPEAN
SELF-MEDICATION INDUSTRY
Substance-based medical devices:
An important part of self-care
Brussels
14-15
October
2015
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Wednesday, 14 October 2015
18.30 - 21.30 RECEPTION & BUFFET DINNER IN THE EUROPEAN
PARLIAMENTS
SALON DES MEMBRES
60 rue Wiertz, Brussels
19.00 Welcome by
Giovanni La Via, Chair, Committee on the Environment,
Public Health and Food Safety, European Parliament
Vytenis Andriukaitis, European Commissioner for Health
Roger Scarlett-Smith, President AESGP
Three years after the publication of the European Commissions
proposal for a regulation on medical
devices in September 2012, the discussion on the new legal
provisions has made considerable progress.
The European Parliament and the EU Member States have taken
their positions. These include considera-
tions for the new requirements specific to self-care medical
devices, and particularly devices composed of
substances or combination of substances (substance-based medical
devices).
In autumn 2015, the medical devices legislation will be
negotiated between the co-legislators: the Euro-
pean Parliament and the EU Member States. It will be essential
to adapt the new rules to the needs and
expectations of patients and consumers, and to ensure an
adequate availability of all types of medical
devices, including self-care medical devices. It is also
important to remember that an objective of the new
legislation is to allow industry to bring safe, effective and
innovative products to the market as quickly
and efficiently as possible.
Understanding the particularities of self-care medical devices
is a prerequisite to discussing the new legal
framework and to avoiding unnecessary regulatory delays while
making sure that the most suitable regu-
latory framework is applied.
In line with these principles, the aims of the conference will
be to provide information on the self-care
medical devices sector, and allow a frank exchange of views on
the current and future legislative and
regulatory environment of self-care medical devices between
representatives of the European Parliament,
the EU Member States, the European Commission, consumer
organisations, industry and other important
stakeholders including notified bodies.
The sessions of the conference will cover the general framework
as well as relevant details of the future
legislation of substance-based medical devices. Participants
will get a good understanding of the future
market conditions which will facilitate an adequate planning of
their activities.
PROGRAMME
Objectives
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THE OVERALL STATUS OF THE REVIEW OF THE MEDICAL DEVICE
LEGISLATION
Panel discussion with the participation of:
Gesine Meissner, Member of the European Parliament
Carlo Pettinelli, Director, DG GROWTH, European Commission
Jean-Pierre Labe, Permanent Representation of Luxembourg to the
EU
Catherine Choma, Ministry of Social Affairs, Health and Womens
Right,
France
John Wilkinson, Director of Medical Devices, Medicines and
Healthcare
products Regulatory Agency (MHRA), United Kingdom
SUBSTANCE-BASED MEDICAL DEVICES: HOW TO ESTABLISH LONG-TERM
SUSTAINABILITY?
Panel discussion with the participation of:
Michle Rivasi, Member of the European Parliament
Judith Neves, Director, Health Products Directorate, Infarmed,
Portugal
Maria Grazia Leone, Ministry of Health, Italy
Matthias Neumann, Ministry of Health, Germany
Andrew Wilson, Member of the AESGP Committee on Medical
Devices
MAKING THE NEW SYSTEM WORK IN REALITY
Panel discussion with the participation of:
Mairead McGuinness, Vice-President of the European
Parliament
Gert Bos, President, The European Association for Medical
devices of Notified
Bodies (TEAM-NB)
Hubertus Cranz, Director General, AESGP
MEDICAL DEVICES: AN IMPORTANT PART OF SELF-CARE
Panel discussion with the participation of:
Matthias Groote, Member of the European Parliament
Maria Iglesia-Gomez, Head of Unit, DG SANTE, European
Commission
Maikel Hendriks, CEO, Medical Brands
Emiliano Giovagnoni, Regulatory Affairs Director, Aboca
Ilaria Passarani, Head of the Food and Health Department,
European
Consumer Organisation (BEUC)
09.00
11.00
14.00
16.30
12.30 Lunch
10.30 Coffee / Tea break
Thursday, 15 October 2015
17.30 Farewell drink
16.00 Coffee / Tea break
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Conference secretariat
AESGP
7 avenue de Tervuren
B-1040 Brussels, Belgium
Tel: +32 2 735 51 30
Fax: +32 2 735 52 22
E-mail: [email protected]
The room rate is per night and includes breakfast. The city tax
of
7,58 per night is excluded.
The rates are valid for reservations made until 29 August
2015;
after this date rates are no longer guaranteed and rooms are
attri-
buted upon availability.
Registration fee: 500
The fee covers the reception and dinner on 14 October and
the
conference, lunch and farewell drink on 15 October 2015.
Please
note that AESGP does not accept credit card payments.
Registration can be made online or using a form that can be
downloaded on the conference website. We recommend registra-
tion before 25 September 2015.
Cancellations
For cancellations received after 5 October 2015, the whole fee
is
withheld.
Updated information on the conference programme will be pro-
vided at aesgp.eu/bru15
Room rates
Deluxe single room:
199.00
Deluxe double room:
219.00
Hotel information
The Renaissance Hotel
19, rue du Parnasse, Brussels
Phone: +32 2 505 2500
Fax: +32 2 505 2473
Email: [email protected]
Room reservations can be made through aesgp.eu/bru15
under Practical Information.
The conference will start on
Wednesday, 14 October 2015
with a reception and buffet
dinner in the European Parlia-
ment. For those without a
permanent access pass to the
European Parliament and
wishing to attend the re-
ception, please make sure to
complete the corresponding
fields in the registration form
AND to bring your identity
document (ID card or
passport) on the day of the
reception. It will be requested
at the Parliaments entrance.
The Renaissance Hotel, where
the meeting on 15 October
will take place, is in a short
walking distance from the
European Parliament.
Self care: The first choice in healthcare
