7/17/2019 AESGP Conference October 2015

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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 

7/17/2019 AESGP Conference October 2015

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Wednesday, 14 October 2015

18.30 - 21.30 R ECEPTION & BUFFET DINNER  IN THE EUROPEAN PARLIAMENT’S 

R ESTAURANT 

60 rue Wiertz, Brussels

18.30  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 Commission’s 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 andregulatory 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 

Introduction and chair: Gesine Meissner , Member of the European Parliament  

Speakers:

Carlo Pettinelli , Director, DG GROWTH, European Commission 

Jean-Pierre Labe, Permanent Representation of Luxembourg to the EU  

Vincent Houdry , Health Advisor, Permanent Representation of France to the EU  

John Wilkinson , Director of Medical Devices, Medicines and Healthcare products Regu-

latory Agency (MHRA), United Kingdom

Discussion

SUBSTANCE-BASED MEDICAL DEVICES: HOW TO ESTABLISH LONG-TERM SUSTAINABILITY?

Introduction and chair: Michèle Rivasi , Member of the European Parliament  

Speakers:

Andrew Wilson , Member of the AESGP Committee on Medical Devices 

Judite Neves , Director, Health Products Directorate, Infarmed, Portugal 

Maria Grazia Leone, Ministry of Health, Italy  

Matthias Neumann , Ministry of Health, Germany  Discussion

MAKING THE NEW SYSTEM WORK  IN REALITY 

Final 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 

Discussion

MEDICAL DEVICES: AN IMPORTANT PART OF SELF-CARE 

Opening: Roger Scarlett-Smith , President, AESGP

Introduction and chair: Matthias Groote, Member of the European Parliament

Speakers:

Aurelien Perez , Policy Officer, 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 Organ-

isation (BEUC) 

Discussion 

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 

08.30 Registration and coffee 

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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 22E-mail: info@aesgp.eu

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 bedownloaded 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 2473Email: brussels.reservations@marriott.com 

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 orpassport) on the day of the

reception. It will be requested

at the Parliament’s 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