ICMRA ‘Rare’ Symposium 2024

About

Join us for the ICMRA ‘Rare’ Symposium and Workshop 2024. A multi-stakeholder event focusing on rare diseases, organised by the International Coalition of Medicines Regulatory Authorities (ICMRA), open to selected stakeholder organisations and to regulators.

The symposium will take place on September 16, 2024 and will be followed by a regulators workshop on September 17, open to participating ICMRA authorities only. The symposium and workshop together aim to appreciate evolving technological and regulatory developments encountered with (ultra-)rare diseases.

Key objectives:

To better appreciate the main challenges and opportunities encountered with (ultra-)rare diseases in translation and clinical development
To critically compare existing regulatory requirements in this space and identify opportunities for innovators/investors, in particular the utilization of DHTs (digital health technologies) for data generation and recruitment.
To hear from patients and caregivers about their journeys and how we can better involve them

Agenda

September 16

12:00

Welcome Coffee

13:00

Introduction

13:15

Keynotes 1: Clinical insights

Bench-to-bedside
How to facilitate clinical development
What we can learn from Oncology

14:30

Panel 1: Recommendations

Group of clinicians and investigators
Lessons learned, expectations, ideas
R&D trends
Regulatory frameworks

15:15

Coffee Break

15:45

Keynotes 2: Digital Health opportunities

Showcasing exciting tech developments
Facilitating R&D
International activities

17:00

Panel 2: Driving Innovation

Big pharma digitized, SME, start-ups
How can DHT help, what’s holding us back?
Over-/under-regulated?
International aspects

17:45

Lakeside chat

Patient and caregiver journeys

18:15

Wrap Up

18:30

End of Symposium

Hotel booking platform

Through our official partner agency, Amiconi Consulting SA, Swissmedic has pre-booked rooms in various hotels in the city of Lugano. All hotels are located within a walking distance of max. 15 minutes from the venue. The hotels have different star categories, locations and prices in order to meet the different needs of the participants.

All participants are responsible for arranging and paying for their own travel to and accommodation during the meeting.

Rooms will be offered on a first-come, first-served basis. The room contingents will be available until 15th August 2024 depending on the hotel you choose. After this date, all hotel rooms will expire and Swissmedic has no longer the possibility to organize accommodation and availability can no longer be guaranteed.

The number of rooms is limited. It is therefore worth booking your room early.

Book your hotel here: https://ticino.e-vent.online/web/50E817DA9B9F4FFFB44C4C18D7A62D04/EN

Travel information

Arriving by air

We recommend flying to one of the following airports:

• Zurich Kloten Airport (CH)

• Milan Malpensa Airport (IT)

The airports of Zurich and Milano are connected to the Swiss railway network and have their own stations.

Trains to Lugano run every 30-60 minutes from all cities. We recommend traveling to Lugano by public transport. Cabs/Taxis are very expensive in Switzerland.

Link to the Swiss railways (SBB/CFF) online schedule: www.sbb.ch

Arriving by train

Tickets for the train can be purchased either online via www.sbb.ch or at one of the ticket machines at the station.

Travel times to Lugano by train

• From Zurich Kloten Airport: approx. 3 hrs

• From Milan Malpensa Airport: approx. 1 hr 30

Arriving by car

Switzerland – and Lugano – is also easily reachable by car from its neighbouring countries as it is linked to the entire European highway network. The Swiss motorway ticket is required when driving through Switzerland in your own vehicle. Click here to buy your Swiss motorway ticket. Rental cars already come with a ticket.

Travel times to Lugano by car:

• From Milano: 80 km, approx. 1 hr

• From Zurich: 220 km, approx. 3 hrs

Useful links

www.myswitzerland.com: Information for travelling to Switzerland

(such as passports & visa, customs entry regulations and electricity)

www.myswitzerland.com: General information about Switzerland and Lugano

www.sbb.ch/en: Swiss Railway System SBB

www.swissmedic.ch: About Swissmedic