ICMRA 'Rare'
Symposium
16 September 2024
Lugano, Switzerland
A very warm ‘welcome’ to our dedicated event website for the ICMRA ‘Rare’ Symposium 2024.
You can register as an on-site or virtual participant for the Symposium, find the agenda concept, venue and travel information as well as a hotel booking platform below.
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) and hosted by Swissmedic, 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
Photo credits: ©LAC 2015 - Foto Studio Pagi
Emer Cooke (EMA) & Raimund Bruhin (Swissmedic)
Claus Bolte (Swissmedic) & Kerry Jo Lee (FDA)
More opportunities than challenges today!
Maria Ester Bernardo, Pediatrician (I) (Link)
Basic & translational research
Tiina K. Urv, NIH (US) (Link)
Pharma R&D (clinical development)
Thomas F. Miller, Industry (US), InsideScientific (Link)
Pragmatic evidence generation in routine care
Lars Hemkens (CH), DKF USB, Pragmatic Evidence Lab (Link)
Academic clinicians and investigators
Keynote 1 speakers
(Ultra-)Orphan Drug Designation?
Daniel Michaeli (D), Nat. Center for Tumor Diseases (Link)
How can DHT help (recruitment, evidence)?
Keynote 2 speakers
Regulatory Science evolving
Elisabeth Kunkoski, FDA (Link)
Low- and middle-income countries
Steffen Thirstrup, CMO EMA
Claus Bolte (Swissmedic) & Kerry Jo Lee (FDA)
ICMRA Steering Committee & Faculty Dinner @20:00 (CET)
Any updates or modifications to the agenda will be promptly reflected on our website. We encourage you to check the website regularly for the most current information.
Please note that the registration for ICMRA ‘Rare’ Symposium is now closed. We are unable to accept any new registrations at this time.
If you have any questions or need further assistance, please don’t hesitate to contact us at events@swissmedic.ch.
Please be aware that our pre-booked hotel room contingents expired on August 14, 2024. While Swissmedic can no longer arrange accommodations, you can still book directly with hotels, though availability may be limited.
For any special requests or assistance, feel free to reach out to info@amiconiconsulting.ch.
Thank you for your understanding.
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
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
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
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