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To registration »
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| Meals & Accommodation |
The participation fee, which includes coffee and lunches is SEK 5.300 before 1 September and SEK 6.400 from that date. If you like to take part in the conference dinner on Wednesday 6 October, the price is SEK 500.
Accommodation
Hotel accommodation is not included in the participation fee. Please make your hotel booking at Radisson Blu Arlandia Hotel For instructions how to book: Read this pdf. In the box for promotional code, write "LAKEM". Please make sure to scroll down the webb page after clicking on "view rates". If you have any problems with the internet booking, please contact the hotel by telephone, +46 8 506 840 00.
After 7 September, 2010, accommodation cannot be guaranteed. The price for a single room is around SEK 1450/night including breakfast.
All prices excl. VAT.
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| Project Administrator |
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Professionals managing and/or coordinating clinical trials over the Nordic boarders who desire a broader understanding of requirements, processes and procedures.
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The aim of the two-day conference is to clarify country specific requirements for conducting clinical trials in the Nordic countries and strengthen cooperation between professionals. Current practical aspects of managing clinical trials in the region will be presented, both country by country and from a Nordic study management´s perspective. Aspects of creating a Nordic organization will be addressed and the possibility to use health registers in clinical research will be discussed. Regulatory representatives from the different countries will present their GCP-inspection work and the Inspectors Working Group within EMA.
This conference will provide an opportunity to interact and converse with colleagues from the different Nordic countries! |
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WEDNESDAY, OCTOBER 6
| 08:30-09:15 |
Registration and coffee/tea |
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09:15-09:30 |
Welcome!
Chairperson: Helena Lomberg
Senior Consultant, BTC Consulting, Sweden |
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09:30-12:00
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Inspections of clinical trials in the Nordic Countries
(10:30-11:00 Coffe/tea)
Philip Lange Møller
Medicines Inspector, Danish Medicines Agency
Gunnar Danielsson
Pharmaceutical Inspector, Medical Products Agency, Sweden
Elham Kossary
Pharmaceutical Inspector, Norwegian Medicines Agency |
| 12:00-13:15 |
Lunch |
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13:15-13:45 |
GCP Inspectors Working Group within the European
Medicines Agency
Philip Lange Møller
Medicines Inspector, Danish Medicines Agency |
| 13:45-14:20 |
Sponsors management and view of inspections
Guri Schüller
PV Regional Lead Scandinavia & Mid Europe, MSD (Norway) AS
Jakob Bjerg Larsen
Specialist consultant, LIF Denmark |
| 14:20-14:50 |
Non-interventional studies
Karin Eriksson
Research Director, LIF Sweden
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| 14:50-15:20 |
Coffee/tea |
| 15:20-16:30 |
Panel Discussion |
| 16:30-16:45 |
Concluding Remarks |
| 16:45 |
End of first day |
| 18:30 |
Dinner and networking |
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THURSDAY, OCTOBER 7
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| 08:30-08:45 |
Introduction to day 2 |
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08:45-12:15 |
Working Nordic – what do I need to know? Hints and tips
(Coffee/tea 9.45-10.15)
Conduct of clinical trials in Norway; Electronic application form for ethics approval and new legislation causing new procedures for the ethics committees
Katrine Ore
Advisor, Regional Committee for Medical and Health Research Ethics, South-East of Norway
Conduct of clinical trials in Denmark; New ethics committee legislation/ Authorization process for access to patients´ medical records?
Speaker TBD
Conduct of clinical trials in Finland; New research act/ New ethics committee structure/ Biobank legislation
Mia Bengtström
Senior Advisor, Pharma Industry Finland
Conduct of clinical trials in Sweden;
The new financial agreement/ E-biobanks/ Access to patient journals
Östen Karlsson
Senior Clinical Process Manager, AstraZeneca, Sweden
Nordic organization pros and cons
Ingela Larsson
Clinical Operations Manager, Janssen-Cilag; Sweden
Study management over the Nordic boarders
Ann-Kristin Lundblad,
Head of Operations L-Wyeth, part of Pfizer, Sweden
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| 12:15-13:30 |
Lunch |
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13:30-14:30 |
Health registers – facilitate clinical research in the Nordic Countries?
Frøydis Langmark
Director, Cancer registry of Norway
Additional speaker TBD |
| 14:30-15:00 |
Coffee/tea |
| 15:00-16:15 |
Panel discussion |
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16:15-16:30
16:30 |
Concluding remarks
End of conference |
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Regulatory authority representatives and key contributors to the field with an advanced knowledge of conducting clinical trials in their respective countries.
Organizers
Swedish Society for Clinical Trials
Swedish Academy of Pharmaceutical Sciences
The Norwegian Association of Pharmaceutical Manufacturers
Pharma Industry Finland
The Danish Association of the Pharmaceutical Industry
LIF - The Research-based Pharmaceutical Industry in Sweden
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| Organizers |
Organizing Committee
Mia Bengtström, Senior Advisor,
Pharma Industry Finland (PIF)
Karin Eriksson, Research Director,
the Research-based Pharmaceutical Industry (LIF), Sweden
Monica Kjeken, Manager of Research and Development,
the Norwegian Association of Pharmaceutical Manufacturers
(LMI), Norway
Jakob Bjerg Larsen, Special Consultant,
The Danish Association of the Pharmaceutical Industry (LIF),
Denmark
Helena Lomberg, Senior Advisor, BCT Consulting, Sweden
Louise Lunt, Project Manager, Swedish Academy of
Pharmaceutical Sciences (SAPS), Sweden
Katarina Thor, GCP-Inspector,
Medical Products Agency, Sweden
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| Time and Location |
The conference will be held at Radisson Blu Arlandia Hotel, near Arlanda airport.
The meeting starts at 09.15 (registration from 08.30) and ends at appr. 16.30 on Thursday 7.
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| Application, confirmation etc |
Cancellation
- should be addressed in writing
- made at the latest Augusti 31 is free of charge
- from September 1 to September 21 you will be charged 50% of the fee
- from September 22 and forward no refund will be done (you will be charged 100% of the fee)
The registration may be transferred at any time to another person. In this case you are kindly requested to forward the name of the substitute to kia.olsson@lakemedelsakademin.se, as soon as possible.
Conference Dinner on October 6, 2010
- cancellation should be addressed in writing
- cancellation at the latest August 31 is free of charge, thereafter no refund.
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