Nov 21 2013 11:30AM - Nov 22 2013 3:00PM | DoubleTree by Hilton (formerly The Burlington Hotel)
Upper Leeson Street
This 1.5 day workshop will focus on the European experience with biosimilar medicinal products. The workshop will give an overview of the current regulatory as well as market-access situation for these products. Moreover, the lessons learned and the challenges faced by two classes of products, Erythropoietin (EPO) and Granulocyte-Colony Stimulation Factor (G-CSF), which were among the first classes of biosimilars approved in the EU, will be addressed and put into perspective for the most recently approved biosimilar monoclonal antibodies.
The workshop is being chaired by Steffen Thirstrup, who was the co-chair for the project group on Market Access for Biosimilars under EC’s Platform on Access to Medicines in Europe.
The workshop will provide
• An update on the current regulatory framework and market-access situation for biosimilars in the EU
• An overview of the regulatory, scientific and market access situation for biosimilars in the EU
PRESENTATION ACCESS INFORMATION
As a benefit of registration, presentations will be made available on the DIA website 1-3 days before the event start date. Please log in to MyDIA and choose My Presentation Downloads, where you will be able to download all presentations that have been submitted by speakers.
Note: You will need to enter your DIA User ID and password to verify your status. If you have forgotten your DIA User ID and password, use our Login Reminder.
Who Should Attend
This conference is aimed at intermediate and experienced professionals from
- Regulatory agencies
- The pharmaceutical industry and service providers
- Academic institutions
- Regulatory affairs personnel
- Pharmacovigilance staff
- Clinical and medical personnel
- Project managers and development
• To provide insight into the regulatory requirements, scientific and operational situation, including challenges associated with biosimilars in the EU
• Attendance will offer opportunities to exchange experiences and engage in discussions with a range of stakeholders in the field of biosimilars
Group Discounts Available – Send 3 participants and the 4th is free!
Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.
Hotel & Travel
DIA has blocked a limited number of rooms at the following hotel:
DoubleTree by Hilton Dublin (formerly The Burlington Hotel)
Upper Leeson Street
Dublin 4, Ireland
Tel: +353 (0)1 618 5600
Fax: +353 (0)1 6185693
at the rate of:
EUR 105.00 per room/night inclusive of breakfast and VAT, plus city tax
To book your accommodation, fill out the Hotel Booking Form. Details of the hotel can be found on the Hotel website.
Important: Please complete your reservation by 5 November 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.
In case of cancellation:
To avoid cancellation charges please cancel accommodation directly with hotel and acquire a cancellation number. If room is cancelled within seven days of arrival date, the hotel will endeavour to resell the space, if unable to resell the space a charge equal to the amount of the first night stay will apply.
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52