Preliminary
programme
AESGP REGULATORY CONFERENCE
09.30 Registration and welcome coffee
10.15 Opening of the conference
10.30 - 12.20 Session 1
Digital transformation of regulatory science and
healthcare
Keywords: digital single market, eHealth, eProduct
information, pharmacovigilance, real world evidence
◼ Guido Rasi, Executive Director, European Medi-
cines Agency (EMA)
◼ Andrzej Rys, Director, Health Systems, Medical
Products and Innovation, Directorate-General
Health and Food Safety, European Commission
◼ Karl Broich, Chair, EU Telematics Management
Board; Director General, Federal Institute for
Drugs and Medical Devices (BfArM), Germany
◼ César Hernández, Head of the Department of
Medicines for Human Use, National Agency for
Medicines and Medical Devices (AEMPS), Spain
◼ Sabine Straus, Chair of the EMA Pharmacovigi-
lance Risk Assessment Committee (PRAC); Head
of Pharmacovigilance, Medicines Evaluation
Board, the Netherlands
◼ Giovanna Ferrari, Regional Labeling Lead, Inter-
national Labeling Group
◼ Jurate Svarcaite, Director General, AESGP
12.00 - 13.30 Lunch
13.30 - 15.00 Session 2
Implementation of the Medical Devices Regula-
tion
Keywords: substance-based medical devices, MDR
implementation, Notified Bodies
◼ Helena Dzojic, Chair, Executive Group of the
Competent Authorities for Medical Devices
(CAMD), Head of Department of Medical Devices,
the Swedish Medical Products Agency, Sweden
Wednesday, 20 March 2019
◼ Zaide Frias, Head of Human Medicines Evalua-
tion Division, European Medicines Agency (EMA)
◼ Françoise Schlemmer, Director, The European
Association of Medical Devices Notified Bodies
(TEAM-NB)
◼ Oliver Bisazza, Director, Regulations & Industrial
Policy, MedTech Europe
◼ Maud Perrudin, Deputy Director General, AESGP
15.00 - 15.30 Coffee/Tea Break
15.30 - 17.00 Session 3
10 years since the first centralised switch. What
have we learnt?
Keywords: centralised procedure, non-prescription
medicines, self-care, access, innovation, switch
◼ Prof. Claudio Jommi, Affiliate Professor of
Government, Health and Not for Profit at SDA
Bocconi School of Management
◼ Ilaria Passarani, Secretary General, PGEU
◼ Gabriella Grippaudo, Senior Director Regulatory
& Medical Affairs EMEA, Pfizer Consumer
Healthcare
◼ Helene Guillard, Global Rx-to-OTC Switch Direc-
tor, HRA Pharma
◼ Zaide Frias, Head of Human Medicines Evalua-
tion Division, European Medicines Agency (EMA)
◼ Christelle Anquez-Traxler, Regulatory and
Scientific Affairs Manager, AESGP
17.00 - 17.30 Conclusions
Conclusions by Hugo Hurts, Executive Director,
Dutch Medicines Evaluation Board (MEB), and Birgit
Schuhbauer, AESGP President and Global Vice-
President strategic marketing OTC, Johnson & John-
son
17.30 Cocktail Reception
Dress code: Business
Objectives of the conference
The conference follows a long-standing tradition to
facilitate exchange between regulators and the
European self-care industry. The results of previous
meetings are available at www.aesgp.eu/events/
previous/.
The AESGP Regulatory Conferences bring together
the industry and regulators as well as other key
stakeholders with the aim of promoting and contin-
uing work towards a more efficient self-care prod-
ucts regulatory system which ensures access to
innovation and optimum public health protection.
Key topics that will be discussed during the confer-
ence are:
◼ Digital transformation of healthcare in the
Digital Single Market
Conference venue
Koninklijke Industrieele Groote Club
Dam 27, 1012 JS Amsterdam
The Netherlands
Event dress code
Leisurewear is not permitted inside the Club. For gen-
tlemen, business attire (e.g. a suit or sports jacket) is
required. For ladies, similarly appropriate attire is
required. Jackets are always worn whilst inside the
Club.
Registration fee: 500 Euro (excl. VAT)
The fee includes participation at the conference,
luncheon, coffee breaks and closing reception on 20
March 2019. Please note that AESGP does not accept
credit card payments.
Registration can be made online or by using a form
that can be downloaded from the conference website.
Visit our conference website on www.aesgp.eu/ams2019
◼ Impact of digital technologies on regulatory
science, product evaluation and risk manage-
ment
◼ Implementation of the medical devices regula-
tion with a particular focus on substance-based
medical devices
◼ Collaboration between medicines and medical
devices regulators
◼ Innovative path of market access to non-
prescription medicines via the centralised pro-
cedure
Ultimately, the conference aims to deliver key,
actionable insights into the very latest regulatory
developments as well as provide an understanding
of the European regulatory strategy for self-care
products.
Participants are encouraged to register by 28 February
2019.
Cancellations
For cancellations received after 28 February 2019, the
whole fee is withheld.
Hotels
In case you need a hotel room, reservations can be
made at the NH Grand Hotel Krasnapolsky or at Hotel
Park Plaza Victoria Amsterdam. More information on
rates and online booking is available on the confe-
rence website.
Conference secretariat
AESGP
7, Avenue de Tervuren
B-1040 Brussels
Tel: +32 2 735 51 30
Email: info@aesgp.eu