www.aesgp.

eu
/MAL17

20-21
February
2017

Excelsior
DEFINING THE PRIORITIES FOR THE Grand
FUTURE DEVELOPMENT OF SELF-CARE Hotel
Malta

Conference with the Heads of EU Medicines

Agencies during the Maltese EU Council Presidency
 PROGRAMME
Objectives of the conference
Self-care is nowadays recognised as a key ele-
ment of healthcare. The European Commissions
report on Good governance of non-prescription
medicines, which was endorsed by all EU Mem-
ber States and relevant stakeholders, explains
concrete ways forward. It paved the way to the
inclusion of specific recommendations in the first
ever European Union Medicines Agencies Net-
work Strategy and multi-annual work programme
calling for improved access to well-established
including non-prescription medicines. In addition,
the Co-ordination Group for Mutual Recognition
and Decentralised Procedures (CMDh) advocates
in its 2020 Strategy easier access to non-
prescription medicines and suggests a number
of concrete actions in its Multi-Annual Work Plan.
All this together is an excellent basis for discuss-
ing future priorities with the heads of the EU
authorities and their colleagues taking into ac-
count the proposals of the AESGP Self-Care
Agenda 2020.
The conference follows a long standing tradition
to facilitate exchange between the Heads of the
EU Medicines Agencies and the European Self-
Care industry. Results of previous meetings are
available at www.aesgp.eu/events/previous/.
Monday, 20 February 2017
19.30
Reception and dinner at the Excelsior
Grand Hotel Malta
20.00
Welcome by:
Birgit Schuhbauer, AESGP President
Christopher Fearne, Minister of Health,
Malta
Helena Dalli, Minister for Social Dialogue,
Consumer Affairs and Civil Liberties, Malta
Tuesday, 21 February 2017
08.30 Welcome coffee
09.00
Opening
Helena Dalli, Minister for Social Dialogue,
Consumer Affairs and Civil Liberties, Malta
Martin Seychell, Deputy Director General
DG SANTE, European Commission
09.30
1 Session 1: Availability of non-
prescription medicines
Chair:
Christa Wirthumer-Hoche, Chair of the
EMA Management Board and Head of the
Austrian Medicines and Medical Devices
Agency (AGES MEA)
Anthony Serracino Inglott, Chairperson,
Malta Medicines Authority
Andreja ufar, Executive Director, Public
Agency of the Republic of Slovenia for
Medicinal Products and Medical Devices
(JAZMP), Slovenia
Kristin Raudsepp, Director General, State
Agency of Medicines, Estonia
Andrzej Rys, Director, Health Systems,
Medical Products and Innovation, DG
SANTE, European Commission
10.30 Coffee break
 PROGRAMME
11.00
Session 2: Regulatory optimi-
2 zation and non-prescription
medicines
Chairs:
Hugo Hurts, Director, Medicines Evaluation
Board (MEB), the Netherlands
Hubertus Cranz, Director General, AESGP
Karl Broich, Director General, Federal Insti-
tute for Drugs and Medical Devices
(BfArM), Germany
Ian Hudson, Chief Executive, Medicines
and Healthcare products Regulatory Agen-
cy (MHRA), United Kingdom
Catarina Andersson Forsman, Director
General, Swedish Medical Products Agency
(Lkemedelsverket), Sweden
Helen Vella, Member of the Co-ordination
Group for Mutual Recognition and Decen-
tralised Procedures-Human, Director, Li-
censing Directorate, Malta Medicines Au-
thority
12.30 Lunch break
14.00
Session 3: How to facilitate
3 moving medicines from pre-
scription to non-prescription
status
Chair:
Xavier de Cuyper, Chief Executive Officer,
Federal Agency for Medicines and Health
Products (FAMHP), Belgium
Zade Frias, Head of Human Medicines
Evaluation Division, European Medicines
Agency (EMA)
Lilian Azzopardi, President, European Asso-
ciation of Faculties of Pharmacy (EAFP)
June Raine, Chair, European Medicines
Agencys Pharmacovigilance Risk As-
sessment Committee (PRAC)
Lorraine Nolan, Chief Executive, Health
Products Regulatory Authority (HPRA),
Ireland
15.30 Coffee break
16.00
Session 4: Future of self-care
4 in a connected world (big
data, eHealth data protec-
tion and empowered patients)
Chairs:
Guido Rasi, Executive Director, European
Medicines Agency (EMA)
Andrzej Rys, Director, Health Systems,
Medical Products and Innovation, DG
SANTE, European Commission
Beln Crespo, Executive Director, Agency
for Medicines and Health Products
(AEMPS), Spain
Thomas Senderovitz, Director General,
Danish Medicines Agency
(Laegemiddelstyrelsen), Denmark
Dirk Ossenberg-Engels, Senior Vice-
President, Head of Region Europe South,
Central and Eastern Europe and Middle
East, Bayer Consumer Care
17.45 Conclusions
18.00 End of the meeting