Lääketietokeskus Koulutus Koulutuskalenteri 2nd Nordic Pharmacovigilance Conference

2nd Nordic Pharmacovigilance Conference

A conference with the Nordic pharma industry organizations and Nordic competent authorities

This conference is a unique opportunity to meet colleagues and listen to regulatory authority representatives and key actors in the field.

Who should attend?

The main audience is pharmacovigilance personnel. Professionals who have an interest in pharmacovigilance, regulatory affairs, compliance and risk management and want an update on the planning for the implementation of the new EU PV legislation in the Nordic countries.

Conference objectives

  • To discuss the impact of the new EU PV legislation and hot topics on pharmacovigilance relevant in the Nordic region
  • To address specific issues of concerns and how to overcome them
  • To offer a unique opportunity to interact and converse with colleagues in the Nordic countries

Organizers 

Pharma Industry Finland, The Research-based Pharmaceutical Industry in Sweden, The Danish Association of the Pharmaceutical Industry, The Norwegian Association of Pharmaceutical Manufacturers, the Icelandic Association of the Pharmaceutical Industry and Pharmaceutical Information Centre.

Participation Fee

The fee (incl. certificate of completion, coffee and lunch) is € 290 before December 3rd and € 390 after that date. All prices given excluding VAT.

Registration and Cancellations

The last official registration date was January 15th but you can still register using the registration form on this web page.

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 fees. Registrations cancelled less than 14 days before the conference will not be eligible for a refund. Cancellations should be addressed in writing.

Contact Information

For further questions, please contact Mia Bengtström, mia.bengtstrom(at)pif.fi

Hotels Closest to the Venue

Holiday Inn Helsinki West

Radisson Blu Seaside Hotel

Exhibition Area

We offer companies an exhibition package for 790 € (+ VAT). All stands come equipped with a power socket, a bar table and a place for company's own roll up. The fee also includes a complimentary registration for one company representative, including lunch and refreshments for the conference day.

The exhibitors:

  • DRA Consulting Oy
  • Medfiles Oy
  • ScanApps
  • TFS Trial Form Support Oy

A conference with the Nordic pharma industry organizations and Nordic competent authorities

This conference is a unique opportunity to meet colleagues and listen to regulatory authority representatives and key actors in the field.

Who should attend?

The main audience is pharmacovigilance personnel. Professionals who have an interest in pharmacovigilance, regulatory affairs, compliance and risk management and want an update on the planning for the implementation of the new EU PV legislation in the Nordic countries.

Conference objectives

  • To discuss the impact of the new EU PV legislation and hot topics on pharmacovigilance relevant in the Nordic region
  • To address specific issues of concerns and how to overcome them
  • To offer a unique opportunity to interact and converse with colleagues in the Nordic countries

Organizers 

Pharma Industry Finland, The Research-based Pharmaceutical Industry in Sweden, The Danish Association of the Pharmaceutical Industry, The Norwegian Association of Pharmaceutical Manufacturers, the Icelandic Association of the Pharmaceutical Industry and Pharmaceutical Information Centre.

Participation Fee

The fee (incl. certificate of completion, coffee and lunch) is € 290 before December 3rd and € 390 after that date. All prices given excluding VAT.

Registration and Cancellations

The last official registration date was January 15th but you can still register using the registration form on this web page.

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 fees. Registrations cancelled less than 14 days before the conference will not be eligible for a refund. Cancellations should be addressed in writing.

Contact Information

For further questions, please contact Mia Bengtström, mia.bengtstrom(at)pif.fi

Hotels Closest to the Venue

Holiday Inn Helsinki West

Radisson Blu Seaside Hotel

Exhibition Area

We offer companies an exhibition package for 790 € (+ VAT). All stands come equipped with a power socket, a bar table and a place for company's own roll up. The fee also includes a complimentary registration for one company representative, including lunch and refreshments for the conference day.

The exhibitors:

  • DRA Consulting Oy
  • Medfiles Oy
  • ScanApps
  • TFS Trial Form Support Oy

Speakers

Regulatory authority representatives from the Danish Health and Medicines Authority, Finnish Medicines Agency, Norwegian Medicines Agency, Swedish Medical Product Agency and European Medicines Agency with an in depth knowledge of their respective countries and the EU/EEA preparations.

Program committee members

Denmark: Ulla Høegh, LIF Denmark
Finland: Mia Bengtström, Pharma Industry Finland
Iceland: Jakob Falur Garðarsson, Frumtök – the Icelandic Association of the Pharmaceutical Industry
Norway: Kjersti Viken, sanofi; Monica Kjeken, LMI
Sweden: Johan Hellmer, Baxter; Maria Stål, Celgene; Anna Olausson, AstraZeneca

Program

8.30 Registration and Welcome Coffee

9.00 Welcome Note 
Mia Bengtström, Senior Advisor, Program Committee Member, Pharma Industry Finland
Jukka Pesonen, Director, Drug Safety (QPPV), Orion Pharma

9.15 First PRAC Experiences
• PRAC Composition and Responsibilities
• PRAC Key Deliverables and Processes
• Interactions Between PRAC, CHMP and CMD(h)
• First Experiences from the PRAC Meetings
Ingebjørg Buajordet, Member of the Pharmacovigilance Risk Assessment Committee (PRAC), NOMA

Industry Comment on How the PRAC Is Working and How the Transparency is Working
Laurent Auclert, MD, Qualified Person Responsible for Pharmacovigilance (QPPV), Sanofi-Aventis R&D
Merete Schmiegelow, Director, Regulatory Policies and Intelligence, Novo Nordisk

Discussion

10.30 Break

10.45 New Pharmacovigilance Legislation – New Paradigms
• Decisions Based on International Experience
• Integrated Benefit/Risk Assessment
• Risk Communication
• Involvement of New Stakeholders
Doris Stenver, Member of the PRAC, DHMA

Industry Reflection 
Johan Hellmér, Deputy EU Qualified Person for Pharmacovigilance, Baxter

12.00 Lunch Break

13.00 Overall Update and What Is up for 2013
Video Contact: Franck Diafouka, Project Manager, EMA

Panel Discussion:
Current Hot Topics in the Nordic Countries Related to the New Pharmacovigilance Legislation

Experience from the Legislation and GVP Modules

Short Introduction by Each Member State

Kirsti Villikka, Member of the PRAC, Fimea
Suvi Loikkanen, Senior Pharmaceutical Officer, Fimea
Doris Stenver, Member of the PRAC, DHMA
Ingebjørg Buajordet, Member of the PRAC, NOMA
Anna Toth, Group Manager Pharmacovigilance Inspections, MPA, Sweden
Kerstin Jansson, Head of Pharmacovigilance Unit, MPA, Sweden

15.10 Coffee Break

15.40 PV Inspections Experience
Anna Toth, Group Manager Pharmacovigilance Inspections, MPA, Sweden

Industry Reflection 
Jukka Pesonen, Director, Drug Safety (QPPV), Orion Pharma

Discussion

Summary of Impressions from the Day
Jukka Pesonen, Director, Drug Safety (QPPV), Orion Pharma

16.30 End of Conference

Lisätietoja

Anja Isoaho
Koulutuspäällikkö
work (09) 6150 4959
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