Lääketietokeskus Koulutus Koulutuskalenteri 6th Conference on Clinical Trials in the Nordic Countries

6th Conference on Clinical Trials in the Nordic Countries

Introduction

Take this opportunity to meet representatives from the competent authorities and other experts within the field of clinical trials. Listen to the latest news and current trends, network with colleagues from the Nordic countries and discuss best practice initiatives. Representatives from both the Nordic authorities and EMA will present their perspective on clinical trials and also participate in panel discussions open for questions. Valuable examples will be presented. You will be able to bring ideas home with you facilitating your work within the field of clinical trials. Welcome to an interesting and fruitful day!

Who should attend?

Professionals who have an interest in clinical trials with a Nordic focus will benefit from attending the conference. We welcome participants from pharmaceutical companies, pharmaceutical and medical device industry associations, health care and academic organizations, national competent authorities, contract research organizations and consultants. 

Topics

• Update on EU Clinical Trial Regulation – Implementation Acts and Publication
• The latest news on development of the Portal – tester’s experiences
• Nordic Regulatory Authority update on the National activities related to the EU Regulations
• The Nordic Authority expectations of a successful clinical trial application
• Impact of the regulatory changes on the clinical data expectations in Europe
• Clinical Trials with Medical Devices and Combination Products
• Big Pharma View on Clinical Trials in the Nordic Region and vision of future drug development

Participation Fee, Meals and Accommodation

Public sector (health care and academic organizations, national competent authorities):

445 EUR + VAT.

Private sector:

Early registration (until 25.9.2017) 745 EUR + VAT. 
Late registration (after 25.9.2017) 845 EUR + VAT.

The participation fee includes lunch, coffee and dinner. Hotel accommodation is not included in the participation fee.

Registration and Cancellations

You can register using the registration form on this web page. The last registration date is 11 October 2017.

If a registrant is unable to attend the conference for any reason they may substitute, by arrangement with the registrar, someone else from the same organisation. Cancellations can be made at no charge up until 30 days before the conference. Registrations cancelled less than 30 but more than 14 days before the conference will be refunded 50 % of the participation fee. Registrations cancelled less than 14 days before the conference will not be eligible for a refund. Cancellations should be addressed in writing.

Register in English: https://www.laaketietokeskus.fi/en/training/training-calendar/the-6th-conference-on-clinical-trials-in-the-nordic-countries 

Hotels Closest to the Venue

  • Holiday Inn Helsinki West
  • Radisson Blu Seaside Hotel
  • Clarion Hotel Helsinki

For more information on hotel booking and payment options, please see the how to book page

Collaboration

The conference will be developed in cooperation with

  • Pharma Industry Finland
  • The Association of the Pharmaceutical Industry in Norway
  • The Danish Health and Medicines Authority
  • The Swedish Medical Products Agency
  • The Swedish Society for Clinical Trials
  • Pharmaceutical Information Centre Ltd

Introduction

Take this opportunity to meet representatives from the competent authorities and other experts within the field of clinical trials. Listen to the latest news and current trends, network with colleagues from the Nordic countries and discuss best practice initiatives. Representatives from both the Nordic authorities and EMA will present their perspective on clinical trials and also participate in panel discussions open for questions. Valuable examples will be presented. You will be able to bring ideas home with you facilitating your work within the field of clinical trials. Welcome to an interesting and fruitful day!

Who should attend?

Professionals who have an interest in clinical trials with a Nordic focus will benefit from attending the conference. We welcome participants from pharmaceutical companies, pharmaceutical and medical device industry associations, health care and academic organizations, national competent authorities, contract research organizations and consultants. 

Topics

• Update on EU Clinical Trial Regulation – Implementation Acts and Publication
• The latest news on development of the Portal – tester’s experiences
• Nordic Regulatory Authority update on the National activities related to the EU Regulations
• The Nordic Authority expectations of a successful clinical trial application
• Impact of the regulatory changes on the clinical data expectations in Europe
• Clinical Trials with Medical Devices and Combination Products
• Big Pharma View on Clinical Trials in the Nordic Region and vision of future drug development

Participation Fee, Meals and Accommodation

Public sector (health care and academic organizations, national competent authorities):

445 EUR + VAT.

Private sector:

Early registration (until 25.9.2017) 745 EUR + VAT. 
Late registration (after 25.9.2017) 845 EUR + VAT.

The participation fee includes lunch, coffee and dinner. Hotel accommodation is not included in the participation fee.

Registration and Cancellations

You can register using the registration form on this web page. The last registration date is 11 October 2017.

If a registrant is unable to attend the conference for any reason they may substitute, by arrangement with the registrar, someone else from the same organisation. Cancellations can be made at no charge up until 30 days before the conference. Registrations cancelled less than 30 but more than 14 days before the conference will be refunded 50 % of the participation fee. Registrations cancelled less than 14 days before the conference will not be eligible for a refund. Cancellations should be addressed in writing.

Register in English: https://www.laaketietokeskus.fi/en/training/training-calendar/the-6th-conference-on-clinical-trials-in-the-nordic-countries 

Hotels Closest to the Venue

  • Holiday Inn Helsinki West
  • Radisson Blu Seaside Hotel
  • Clarion Hotel Helsinki

For more information on hotel booking and payment options, please see the how to book page

Collaboration

The conference will be developed in cooperation with

  • Pharma Industry Finland
  • The Association of the Pharmaceutical Industry in Norway
  • The Danish Health and Medicines Authority
  • The Swedish Medical Products Agency
  • The Swedish Society for Clinical Trials
  • Pharmaceutical Information Centre Ltd

DAY 1: EU CLINICAL TRIAL REGULATION 

10.00 Registration and Welcome Coffee

11.00 Welcome and practicalities
Mia Bengtström, Senior Advisor, Pharma Industry Finland

11.05 Welcome and introduction
Moderator Philip Lange Møller, Medicines Inspector, Danish Medicines Agency

11.10 Update on Regulation
Implementation Acts and Publication Given by EU Commission
● Replacing Vol 4, Annex 13 and Update
TBC

12.10 The latest news on development of the Portal – tester’s experiences
TBC

12.50 Lunch and networking

14.00 The Pharma view of the EU clinical trial regulation
Nick Sykes, Director, European Regulatory Policy, Pfizer

14.30 Roll out of the Portal – educational plan
TBC

15.00 Nordic Regulatory Authority update on the National activities related to the EU Regulations
DK: TBC
FIN: TBC, Ministry of Social Affairs and Health
IS: Eirikur Baldursson, Managing Director, National Bioethics Committee, Iceland
NO: Ingvild Aaløkken, Head of Section, Norwegian Medicines Agency
SWE: Gunilla Andrew-Nielsen, Head of Clinical Trials, Medical Product Agency

16.20 Coffee

16.50 Q&A session
Moderator Outi Konttinen, General Secretary, National Committee on Medical Research Ethics (TUKIJA)

17.45 End of the first conference day

18.00 Buss to Helsinki City Hall, Pohjoisesplanadi 11-13

18.30 Reception, Networking and “Food for Thought and Stomach”

19.30 End of the official conference day

DAY 2: CLINICAL TRIALS IN THE NORDIC REGION – INTERESTING ASPECTS 

8.00  Registration and Welcome Coffee

Moderator Helena Lomberg, Director Clinical Operations, Owner, BCT Consulting

8. 30 Clinical Trials with Medical Devices and Combination Products - Competent Authorities’ and Notified Bodies’ point of view

(8.30) The Nordic Authority expectations of a successful clinical trial application
Elin Karlberg, Regulatory Assessor, Medical Devices, Medical Products Agency, SWE

(9.00) Impact of the regulatory changes on the clinical data expectations in Europe
Bassil Akra, Vice President, Global Focus Teams, TÜV SÜD Product Service, DE

(9.40) Challenges in medical device trials
Philip Lange Møller, Medicines Inspector, GCP Inspector, Danish Medicines Agency

10.00 Panel Discussion

10.40 Coffee

11.10 NOPHO (Nordic Organization for Pediatric Hematology and Oncology)
Mervi Taskinen, Docent, Consultant in Pediatric Hematology Oncology, Hospital District of Helsinki and Uusimaa (HUS)

11.30 Nordic NECT
Katriina Peltola, Senior Consultant, Early Phase Trial Unit, Comprehensive Cancer Center, Helsinki University Hospital

11.50 Nordic Lymphoma Group
Sirpa Leppä, Professor, Department of Oncology, Helsinki University Central Hospital Cancer Center

12.10 Recruiting patients from other Nordic Countries
Steinar Aamdal, Professor, Head of Section for Clinical Cancer Research and Resource Development, Oslo University Hospital, Norway

12.30 Discussion

12.50 Lunch

Moderator Mia Bengtström, Senior Advisor, Pharma Industry Finland

14.00 NSGO: 30 years of fruitful Nordic collaboration in clinical trials
Mansoor Raza Mirza, Chief Oncologist at the Department of Oncology, PhD, Rigshopitalet, Copenhagen, DK

14.20 IMI EHR4CR (electronic health records for clinical research)
● What is IMI EHR4CR and why is it important for Pharma and the Nordic countries
Juuso Blomster, Director Physician, AstraZeneca AB, SWE

14.50 Coffee

15.20 SME View on Clinical Trials in the Nordic Region and vision to the future
Mansoor Raza Mirza, Chief Oncologist at the Department of Oncology, PhD, Rigshopitalet, Copenhagen, DK

15.50 Big Pharma View on Clinical Trials in the Nordic Region and vision of future drug development
Tom Lillie, Vice President, Head of European Clinical Development, MSD

16.30 Welcome to the 7th Conference on Clinical Trials in the Nordic Countries
Katrine Bryne, Advisor, The Association of the Pharmaceutical Industry in Norway (LMI)

16.40 Conference Wrap-Up & End of the Conference

17.00 Bus to the Airport

Lisätietoja

Milla Kajanne
Koulutuspäällikkö
work 050 372 9162
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