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Safer Europe Without Falsified Medicines Conference

The Conference will address the subject of implementing the safety features of medicinal products in the European Union

Calendar

November 8-9, 2017

Marker

Tallinn, Estonia

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About

Safer Europe Without Falsified Medicines Conference will be held during the period of the Estonian Presidency of the EU Council and supports Estonia’s priorities as the ICT projects leader in Europe.

The aim of the Conference: 

 • To understand the current state of implementation of the safety features of medicinal products at the European Union level and in Member States

  • To identify the challenges for stakeholders and governments in implementing the safety features of medicinal products

  • To develop ideas for coping with challenges 

The Conference will address the subject of implementing the safety features of medicinal products in the European Union (Commission Delegated Regulation (EU) 2016/161). The main focus of the Conference is on the practical aspects of the preparations made by governments and stakeholders, also including legal aspects of the process and the implementation of IT solutions on national and European Union levels. By February of 2019 all EEA countries should run IT-based detection systems for all prescription-only medicines to detect falsified medicines in the legal chain.

Representatives of EU Agencies of Medicines, civil servants from health sector, representatives of National Medicines Verification Organizations, representatives of international and local pharmaceutical manufacturers, pharmacies and pharmaceutical wholesale organizations are expected to participate in the conference. Journalists and representatives of related sectors are also welcome to the conference. 

The Conference will be organised in co-operation with:
  • Ministry of Social Affairs
  • Estonian State Agency of Medicines (SAM)
  • Association of Pharmaceutical Manufacturers in Estonia (APME)
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • European medicines verification organisation (EMVO)
  • European Healthcare Distribution Association (GIRP)
  • Pharmaceutical Group of the European Union (PGEU)
  • European Association of Euro-Pharmaceutical Companies (EAEPC)
  • Medicines For Europe
  • Estonian Pharmacies Association (EAÜ)
  • Estonian Association of Pharmaceutical Wholesalers (RHL)

Program

Day 1

Wednesday, November 8, 2017

Day 2

Thursday, November 9, 2017

12:00

Registration and coffee


13:00

Setting the Scene

Organization

Estonian Ministry of Social Affairs

EU Commission

Presentations
  • Welcome
  • Situation with the falsified medicines in the world and in Europe
  • Overview of the requirements in EU
  • Benefits for the patients
Chair

Estonian Ministry of Social Affairs

Keynote address: Mr Andrzej Rys, Director of Health Systems and Products DG SANTE, European Commission


13:30

European and National Medicines Verification Organizations – state of play

Organization

EMVO
NMVOs

Presentations
  • EMVO – what is the status
  • Overview of NMVOs, Estonian experience
  • Repositories – central HUB, national repositories, what is ready, what is under development, what data is available to whom
Chair

Chair: Mr Andreas Walter, General Manager, EMVO
Speakers: Mr Mart Levo, Chief Executive, REKS
Ms Maija Gohlke-Kokkonen, Executive Director, FiMVO
Ms Leonie Clarke, Project Manager, IMVO
Ms Illiana Paunova, Executive Director, BgMVO


15:00

Coffee break


15:30

Developers of the new system – their challenges in setting up data repositories

Organization

EU stakeholders and EMVO

Presentations
  • View of stakeholders: – Manufacturers (EFPIA, EAEPC, Medicines for Europe) – Wholesalers (GIRP) – Pharmacies (PGEU)
Chair

Chair: Mr Per Troein, VP Strategic Partners QuintilesIMS
Speakers:
Ms Monika Derecque-Pois, Director General, GIRP
Mr Richard Freudenberg, Chief Executive, EAEPC
Mr Michael Rose, Vice President, Supply Chain Visibility, Johnson & Johnson and Chair of EFPIA’s Supply Chain
Ms Jurate Svarcaite, Secretary General, PGEU
Mr Adrian van den Hoven, Director General, Medicines for Europe
5 minutes each presenter, panel discussion


17:00

Coffee break


17:30

Challenges of implementing hospitals within NMVS

Organization

FAMHP
HOPE
EAHP
EMVO

Presentations
  • Panel discussion
Chair

Mr Philippe De Buck, FAMHP
Mr Pascal Garel, Chief Executive, HOPE
Ms Stephanie Kohl, EAHP
Mr Hugh Pullen, EMVO


18:30

Reception & dinner


9:00

IV session
Implementing by the Member States – timetable and challenges

How to get more value
– future developments
– additional applications
– is it possible?

Organization

HMA – Heads of Medicines Agencies
EMVO stakeholders

Presentations
  • National requirements – ATD (Anti-tampering Device) on OTC products, extension of the requirement of safety features, multi-market packs vs potential inclusion of national reim-bursement numbers in data matrix codes, update of marketing authorization files
  • Supervision of repositories – who is responsible for what
  • National Competent Authorities’ access to data contained in repositories
Chair

Chair: Ms Belén Crespo Sánchez-Eznarriaga,
Director General, Spanish Agency of Medicines and Medical Devices

Panel: with participation of representatives from National Competent Authorities (NCA), Commission and EMVO stakeholders
Speakers:
Mr Michael Rose, Vice President, Supply Chain Visibility, Johnson & Johnson and Chair of EFPIA’s Supply Chain
Ms Jurate Svarcaite, Secretary General, PGEU
Ms Monika Derecque-Pois, Director General, GIRP
Ms Jan MacDonald, Head Patient Information Quality, MHRA
Ms Agnès Mathieu-Mendes, Deputy Head, DG SANTE, European Commission


10:30

Coffee break


11:00

Availability of medicinal products after Feb 2019

Organization

Estonian State Agency of Medicines (SAM)
EMVO stakeholders

Presentations
  • How do Member States intend to use the data contained in repositories?
  • To what extent the setting up of EMVS (European Medicines Verification System) would impact availability?
  • Will the situation with the availability of medicines worsen or improve?
Chair

Chair:
Ms Kristin Raudsepp, Director General, Estonian State Agency of Medicines
Speakers:
Mr Adrian van den Hoven, Director General, Medicines for Europe
Mr Richard Freudenberg, Chief Executive, EAEPC
Ms Stephanie Kohl, Policy Officer, EAHP


12:00

Is Europe ready?

Presentations
  • Identification of key priority issues for progressing implementation & recom-mendations for action
  • Conclusions of the conference
Chair

Moderator:
Ms Agnès Mathieu-Mendes, B4, Deputy Head, DG SANTE, European Commission
Panellist:
Mr Andreas Walter, General Manager, EMVO
Ms Anci Kvarnström, CEO, PhQConsulting AB, NMVO Sweden


13:00

Lunch


Print the whole program (preliminary)

Registration

Participation in the Conference is free of charge
The conference will be held in English without translation

Calendar icon

November 8-9, 2017

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Tallinn, Estonia

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Hotels

The Conference participants will get a special discount at Nordic Hotel Forum, Go Hotel Shnelli or PK Ilmarine Hotel with the password fmd.

Nordic Hotel Forum

Nordic Hotel Forum

Nordic Hotel Forum, the superior four-star business hotel, welcomes you on the edge of the Old Town in the heart of Tallinn and a 10-minute walk away from the conference venue.

Go Hotel Schnelli

Go Hotel Shnelli

Hotel is an ideal stop for anyone who appreciates kind service, superb location and affordable prices. Only a 10-minute walk away from the conference venue.

PK Ilmarine Hotel

PK Ilmarine Hotel

With just a 3 minute walk to the venue, PK Ilmarine Hotel offers you amazing location just next to the Old Town. For special discount contact us: booking.ilmarine@pkhotels.eu.


Location

Safer Europe Without Falsified Medicines Conference

The venue of the conference, Kultuurikatel, is only a 15 minute taxi drive from the airport.

Kultuurikatel, Watch the video
Põhja puiestee 27a,
10415 Tallinn, Estonia
http://kultuurikatel.ee/

Contact us

Pia Kuusik +372 5635 7866
Sirli Peepson +372 5566 4868

About Estonia

Estonia is a country in the Baltic region of Northern Europe bordered to the north by the Gulf of Finland, to the west by the Baltic Sea, to the south by Latvia and to the east by Lake Peipus and Russia. Across the Baltic Sea lie Sweden and Finland.

Tallinn is the capital city of Estonia and a perfect destination if you want to combine the comforts of modern world and luxurious adventures with rich cultural scene in the local historical setting.

Tallinn Old Town is one of the best preserved Hanseatic town centres in the world. The oldest continuously running pharmacies in Europe, Reval Raeapteek, is located in Tallinn. Raeapteek has been in the same building since the early 15th century, celebrating its 595th anniversary this year. A stone’s throw away you’ll find the city’s business centre with modern towers and luxurious hotels, trendy neighbourhoods and large shopping centres. First established in the early medieval era, today’s Tallinn is an exciting mix of old and new.

Here’s the good news: with Tallinn being such a compact, green capital, you can cover a lot in just a weekend and enjoy short scenic strolls while at it.

Population density in Estonia is 30.3 people per km². That is almost four times less than EU’s average – 116.7 people per km² –, making Estonia the third sparsely populated country in EU.

Estonia’s air is among the cleanest in the world, and the freedom to roam is codified in law. Pick berries, mushrooms, or herbs. Go hiking. Or sit still and take inspiration from the sounds of nature.

A short ride is all that’s required to experience Estonia’s full natural diversity. Little distance separates cities and nature. Our versatile cultural heritage and seasons of the year make every visit unique.

"e-Estonia", the E is for electronic, has become the go to tag to describe Estonia's immensely successful love affair with all things networked and digitised. Country wide enthusiasm for the efficiency of E has enthralled both citizens and policymakers alike. Estonian programmers have been behind the creation of digital brands such as Skype, Hotmail and more recently Transferwise (a online currency converter which has attracted investment from the likes of Richard Branson). The Estonian state currently offers 600 e-services to its citizens and 2,400 to businesses. For years, the digital prescription and digital health record have been used in Estonia.