FINDING THE RIGHT BALANCE FOR

CONSUMER HEALTH PRODUCTS

10-11 OCTOBER 2017

ASSOCIATION OF THE EUROPEAN
SELF-MEDICATION INDUSTRY
Brussels, Belgium
OBJECTIVES OF THE CONFERENCE

Self-care is nowadays recognised as a key element of healthcare. This is re-

flected in numerous policy documents and backed by studies demonstrating
the economic and social value of self-care. However, there are still uncertain-
ties when it comes to the most appropriate balance between the three legal
categories of self-care products: non-prescription medicines, food supple-
ments and self-care medical devices.

The AESGP conference near the premises of the European Parliament will pro-
vide an update on the regulatory challenges for consumer health products
with a focus on relevant developments around substance-based medical de-
vices, food products and (traditional) herbal medicines. Particular attention
will be paid to the implementation of the new medical device legislation and
the ongoing discussion on botanical claims.

The event will start on Tuesday, 10 October 2017 at 18.30 with a reception in
the European Parliament hosted by Adina-Ioana Vlean, Chair of the Com-
mittee on the Environment, Public Health and Food Safety of the European
Parliament. Guest speaker will be Vytenis Andriukaitis, European Commissio-
ner for Health and Food Safety.

The meeting will continue on Wednesday, 11 October 2017 in the Renaissance

Brussels Hotel (Rue du Parnasse 19, 1050 Brussels) until 17.45.

PROGRAMME
Tuesday, 10 October 2017
European Parliament

18.30 - 20.30 RECEPTION & BUFFET DINNER IN THE EUROPEAN PARLIAMENT

60 rue Wiertz, Brussels

19.15 WELCOME
Adina-Ioana Vlean, Chair of the Committee on the Environment,
Public Health and Food Safety of the European Parliament
Vytenis Andriukaitis, Commissioner for Health and Food Safety,
European Commission
Hubertus Cranz, AESGP Director General
 Wednesday, 11 October 2017
Renaissance Hotel

08.30 Registration and coffee

09.00 FOOD PRODUCTS AND HEALTH WHICH DIRECTION TO GO?

Moderated by Renate Sommer, Member, Committee on Environment, Public Health and Food Safe-
ty (ENVI), European Parliament
Nathalie Chaze, Deputy Head of Cabinet of Commissioner Vytenis Andriukaitis, European
Commission
Camilla Smeraldi, Senior Scientific Officer, Food Ingredients and Packaging Unit, European
Food Safety Authority (EFSA)
Amire Mahmood, Federal Ministry of Health, Austria
Ilaria Passarani, Head of the Food and Health Department, European Consumer Organisa-
tion (BEUC)

10.30 Coffee / Tea break

11.00 THE REAL IMPLICATIONS OF THE NEW MEDICAL DEVICE LEGISLATION
Moderated by Gesine Meissner, Member, Committee on Environment, Public Health and Food Safe-
ty (ENVI), European Parliament
Carlo Pettinelli, Director, Consumer, Environmental and Health Technologies, Directorate
General Internal Market, Industry, Entrepreneurship and SMEs, European Commission
John Wilkinson, Director of Medical Devices, Medicines and Healthcare products Regulatory
Agency (MHRA), United Kingdom
Emiliano Giovagnoni, Regulatory Affairs Director, Aboca
Bettina Funke, Head of Medical Device, Scientific & Regulatory Affairs, R&D Consumer
Health Care, Merz Consumer Care GmbH

12.30 Lunch / Networking

14.00 FOSTERING MARKET ACCESS FOR SUBSTANCE-BASED MEDICAL DEVICES
Moderated by Maud Perrudin, Legal and Regulatory Affairs Manager, AESGP
Roberta Marcoaldi, Director of Notified Body 0373 Istituto Superiore di Sanit (ISS), Italy
Bassil Akra, Vice President, TV SD, Germany
Jrg Wilke, Zertifizierungsgesellschaft fr Medizinprodukte in Europa mbH (ECM)
Maikel Hendriks, CEO, Medical Brands

15.30 Coffee / Tea break

16.00 CREATING A PROPORTIONATE REGULATORY ENVIRONMENT FOR HERBAL MEDICINAL PRODUCTS
Moderated by Hubertus Cranz, Director General, AESGP
Karin Kadenbach, Member of the European Parliament
Agns Mathieu-Mendes, Deputy Head of Unit, Directorate Health and Food Safety, Europe-
an Commission
Werner Knss, Head of Division, Complementary and Alternative Medicines and Traditional
Medicines, Federal Institute for Drugs and Medical Devices, Germany
Susanne Keitel, Director, European Directorate for the Quality of Medicines & Healthcare
(EDQM), Council of Europe
Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP

17.45 END OF THE MEETING

Hotel information Room rates
The Renaissance Hotel
19, rue du Parnasse, Brussels
Single room:
Phone: +32 2 505 2500 219.00
Fax: +32 2 505 2473
Email: brussels.reservations@marriott.com Double room:
Room reservations can be made through www.aesgp.eu/ 239.00
bru17 under Practical Information.

The room rate is per night and includes full American breakfast and The conference will start on
WiFi. The city tax of 7.58 per night is excluded. Tuesday, 10 October 2017
The rates are valid for reservations made until 25 August 2017; after
with a reception and buffet
this date, rates are no longer guaranteed and rooms are attributed
dinner in the European Parlia-
upon availability.
ment. For those without a
permanent access pass to the
Registration fee: 500
European Parliament and
The fee includes participation at the evening reception and buffet wishing to attend the re-
dinner at the European Parliament on Tuesday, 10 October 2017 and ception, please make sure to
the conference, lunch and coffee breaks at the Renaissance Hotel on complete the corresponding
Wednesday, 11 October 2017. Please note that AESGP does not accept fields in the registration form
credit card payments. AND to bring your identity
document (ID card or
Registration can be made online or using a form that can be down- passport) on the day of the
loaded on the conference website. We recommend registration before reception. It will be requested
22 September 2017 . at the Parliaments entrance.

Cancellations The Renaissance Hotel, where

For cancellations received after 2 October 2017, the whole fee is with-
the meeting on 11 October
held.
will take place, is in a short
walking distance from the
Updated information on the conference programme will be provided
European Parliament.
at www.aesgp.eu/bru17

Conference Secretariat

AESGP
7 avenue de Tervuren
B-1040 Brussels, Belgium
Tel: +32 2 735 51 30
Self care: The first choice in healthcare
Fax: +32 2 735 52 22
E-mail: info@aesgp.eu