A (re)new(ed) agenda for self-care products

Towards a sustainable framework for self-care products

Brussels | 8 - 9 October 2019
 PROGRAMME
Objectives of the conference
Self-care products make an important
contribution to the health and well-being
of Europeans. Individuals want to take
greater responsibility for their own health
and well-being; this combined with de-
mographic changes and the increasing
pressure on healthcare system requires to
advance responsible self-care in order to
make European health systems future-
proof.
The ability of individuals to self-care safe-
ly and effectively can be enhanced by
improving the regulatory system for self-
care products. With this aim, the AESGP
Conference brings together the self-care
industry, legislators and regulators as well
as other key stakeholders to discuss how
to further improve the current framework
for self-care products, notably non-
prescription medicines, substance-based
medical devices and food supplements.
Ultimately, the conference aims to deliver
key, actionable insights into the very lat-
est regulatory developments as well as
provide an outlook to what a future regu-
latory landscape might look like.
Tuesday, 8 October 2019
European Parliament
(Rue Wiertz 60, 1047 Brussels)
18.30 - 20.30 Opening evening
19.15 Welcome
Cristian-Silviu Busoi, MEP (EPP), Vice-
Chair, ENVI Committee
Birgit Schuhbauer, President, AESGP
Wednesday, 9 October 2019
Renaissance Brussels Hotel
(Rue du Parnasse 19,1050 Brussels)
08.30 Registration and welcome coffee
09.00 - 10.30 Session 1
Changes and challenges pertaining to
the regulatory framework of food sup-
plements
Keywords: food supplements, nutrition and
health claims, botanicals, transparency of
food risk assessment, food additives, novel
food
◼ Alexandra Nikolakopoulou, Head of
Food information and composition, food
waste unit, European Commission
◼ Camilla Smeraldi, Senior scientific of-
ficer, Food Ingredients and Packaging
Unit, European Food Safety Authority
◼ Rafael Perez Berbejal, Policy Officer,
Food processing technologies and novel
foods unit, European Commission
◼ Maud Perrudin, Deputy Director Gen-
eral, AESGP
10.30 - 11.00 Coffee break
11.00 - 12.30 Session 2
Implementation of the Medical Devices
Regulation
Keywords: substance-based medical devic-
es, MDR implementation, Notified Bodies,
Borderline and Classification
◼ Claudia Gamon, MEP (Renew Europe),
ITRE Committee
 PROGRAMME
◼ Salvatore D’Acunto, Head of Unit 15.30- 16.00 Coffee break
Health Technology and Cosmetics,
European Commission 16.00 - 17.30 Session 4
◼ The European Association of Medical
Devices Notified Bodies (TEAM-NB) The European Self-care Agenda - A
(tbc) Stakeholder Perspective
◼ Ivana Hayes, Regulatory Affairs Of- Keywords: responsible self-care, health
fice, Scientific and Regulatory Man- and well-being, citizen empowerment,
agement Dept., European Medicines sustainability of healthcare systems
Agency (EMA)
Maud Perrudin, Deputy Director
Ilaria Passarani, Secretary General,
◼

General, AESGP
◼

PGEU
Usman Khan, Executive Director, EPF
12.30 - 14.00 Lunch/Networking
◼

◼ Aurélien Perez, Policy Officer, Direc-

torate Health and Food Safety, Euro-
14.00 - 15.30 Session 3
pean Commission
Jurate Svarcaite, Director General,
Functioning of marketing authorisa-
◼

AESGP
tion procedures (MRP/DCP) for non-
prescription medicines
17.30 - 17.45 Conclusions
Keywords: mutual recognition proce-
dure, decentralised procedure, non-
prescription medicines

◼ Mark Griffiths, Vice President, Head

of Consumer Regulatory & CMC
EMEA, Global Smoking Cessation,
Cough Cold & Digestive Health,
Johnson & Johnson Consumer Ser-
vices EAME Ltd
◼ Martin Huber, Chair of the CMDh
Non-Prescription Medicinal Products
Task Force
◼ Frank Waimer, General Manager
Operations, Dr. Willmar Schwabe
GmbH & Co. KG
◼ Reinhard Laenger, Head of De-
partment on Herbal, Homoeopathic
and Veterinary Medicinal Products,
Austrian Agency for Health and Food
Safety
Registration fee: 500 Euro (excl. VAT*)
The fee includes participation at the evening re-
ception at the European Parliament on Tuesday, 8
October 2019 and the conference, lunch and
coffee breaks at the Renaissance Brussels Hotel on
Wednesday, 9 October 2019.
* AESGP Conferences are subject to the VAT rules
of the country where the conference takes place.
Registration can be made online or by using a
form that can be downloaded from the confe-
rence website.