Lääketietokeskus Koulutus Koulutuskalenteri 5th Nordic Pharmacovigilance Conference

5th Nordic Pharmacovigilance Conference

In cooperation with the Nordic national competent authorities and the Nordic pharma industry.

The aim of this conference is to highlight hot topics within the field of pharmacovigilance legislation and to discuss challenges in implementing the new legislation in every day practice.

Meet over 100 Nordic experts!

Introduction

Take this opportunity to meet representatives from the competent authorities and other experts within the field of pharmacovigilance. 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 pharmacovigilance and also participate in 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 pharmacovigilance. Welcome to an interesting and fruitful day!

Topics

  • Eudravigilance 8 and Changes in EU PV Reporting
  • Risk Management Plans: New GVP Module V and New RMP Template 
  • EMA’s Medical Literature Monitoring Service 
  • Maintaining Oversight of the Risk Management System 
  • Current Challenges with Risk Minimisation Materials 
  • Pharmacovigilance for Biologicals – GVP PII Biologics 
  • Patient Involvement in Adverse Drug Reaction Reporting 
  • Audits and Inspections 
  • EU Data Protection Regulation and Its Impact on PV

Who should attend?

Professionals who have an interest in pharmacovigilance and drug safety with an EU/Nordic focus will benefit from attending the conference. We welcome participants from pharmaceutical companies (HQ and affiliates), pharmaceutical industry associations, national competent authorities, contract research organizations and consultants. You may also be working in the field of regulatory affairs, drug discovery/drug development or drug information and marketing.

Time and Place

The conference is held 11 October 2017 at Team Finland House, Porkkalankatu 1 (Auditorium), Helsinki. 

The conference starts at 9.00 AM (registration and coffee from 8.00 AM) and ends approx. at 5.00 PM. With reservation to minor changes. More information about the schedule will be published soon.

Participation Fee, Meals and Accommodation

Early registration (until 11.9.2017) 395 EUR + VAT.
Late registration (after 11.9.2017) 475 EUR + VAT.
The participation fee includes lunch and coffee.

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 27 September 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/5th-nordic-pharmacovigilance-conference

Exhibitor Information

During the 5th Nordic Pharmacovigilance Conference we offer companies an exhibition package at a price of 995 EUR + VAT. Stands come equipped with a bar table and a place for the exhibitor’s roll up. The fee also includes a complimentary registration for one company representative, including lunch and coffee for the conference day.

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:

 

In cooperation with the Nordic national competent authorities and the Nordic pharma industry.

The aim of this conference is to highlight hot topics within the field of pharmacovigilance legislation and to discuss challenges in implementing the new legislation in every day practice.

Meet over 100 Nordic experts!

Introduction

Take this opportunity to meet representatives from the competent authorities and other experts within the field of pharmacovigilance. 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 pharmacovigilance and also participate in 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 pharmacovigilance. Welcome to an interesting and fruitful day!

Topics

  • Eudravigilance 8 and Changes in EU PV Reporting
  • Risk Management Plans: New GVP Module V and New RMP Template 
  • EMA’s Medical Literature Monitoring Service 
  • Maintaining Oversight of the Risk Management System 
  • Current Challenges with Risk Minimisation Materials 
  • Pharmacovigilance for Biologicals – GVP PII Biologics 
  • Patient Involvement in Adverse Drug Reaction Reporting 
  • Audits and Inspections 
  • EU Data Protection Regulation and Its Impact on PV

Who should attend?

Professionals who have an interest in pharmacovigilance and drug safety with an EU/Nordic focus will benefit from attending the conference. We welcome participants from pharmaceutical companies (HQ and affiliates), pharmaceutical industry associations, national competent authorities, contract research organizations and consultants. You may also be working in the field of regulatory affairs, drug discovery/drug development or drug information and marketing.

Time and Place

The conference is held 11 October 2017 at Team Finland House, Porkkalankatu 1 (Auditorium), Helsinki. 

The conference starts at 9.00 AM (registration and coffee from 8.00 AM) and ends approx. at 5.00 PM. With reservation to minor changes. More information about the schedule will be published soon.

Participation Fee, Meals and Accommodation

Early registration (until 11.9.2017) 395 EUR + VAT.
Late registration (after 11.9.2017) 475 EUR + VAT.
The participation fee includes lunch and coffee.

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 27 September 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/5th-nordic-pharmacovigilance-conference

Exhibitor Information

During the 5th Nordic Pharmacovigilance Conference we offer companies an exhibition package at a price of 995 EUR + VAT. Stands come equipped with a bar table and a place for the exhibitor’s roll up. The fee also includes a complimentary registration for one company representative, including lunch and coffee for the conference day.

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:

 

Speakers

Mia Bengtström, Senior Advisor, Pharma Industry Finland
Terhi Lehtinen, Senior Medical Officer, Fimea
David Lewis, Global Head of Pharmacovigilance, Novartis Pharma AG
Tom Paternoster-Howe, Scientific Administrator, EMA
Jukka Pesonen, Director, Drug Safety (QPPV), Orion Corporation
Doris Stenver, Member of the PRAC, EMA/DKMA
Johan Sundberg, Partner, DLA Piper, Sweden
Johan Thörn, Senior Associate, DLA Piper, Sweden
Helena Tidlund, Pharmacovigilance Inspector, Drug Inspectorate Industry and Hospital, MPA, Sweden
Raphael Van Eemeren, Global Safety Senior Manager, Amgen, Sweden
Magnus Ysander, EU QPPV and Head Risk Management & Pharmacovigilance Excellence, AstraZeneca, Sweden
 

Organising Committee

Mia Bengtström, PIF, Finland
Annemette A. Boye, Merck, Denmark
Anita Finne Grahnén, LIF, Sweden
Elsa Hedén, Bayer, Sweden
Anja Isoaho, Pharmaceutical Information Centre, Finland
Inge Johansen, LMI, Norway
Terhi Lehtinen, Fimea, Finland
Benedicte Lunddahl, DKMA, Denmark
Marie Lundström, MPA, Sweden
Jukka Pesonen, Orion Corporation, Finland
Mikkel Møller Rasmussen, LIF, Denmark
Emma Wiman, Linde, Sweden
Päivi Ylä-Kotola, Farenta, Finland

Program

Moderator: Jukka Pesonen, Director, Drug Safety (QPPV), Orion Corporation

8.00  Registration and Coffee

9.00  Welcome and Introduction
Mia Bengtström, Senior Advisor, Pharma Industry Finland
Jukka Pesonen, Director, Drug Safety (QPPV), Orion Corporation

9.15  Eudravigilance 8 and Changes in EU PV Reporting 
Tom Paternoster-Howe, Scientific Administrator, EMA

9.50  Risk Management Plans: New GVP Module V and New RMP Template 
Doris Stenver, Member of the PRAC, EMA/DKMA

Discussion

10.20  Coffee

10.40  EMA’s Medical Literature Monitoring Service 
Tom Paternoster-Howe, Scientific Administrator, EMA

11.10  Maintaining Oversight of the Risk Management System
Magnus Ysander, EU QPPV and Head Risk Management & Pharmacovigilance Excellence, AstraZeneca, Sweden

11.40  Current Challenges with Risk Minimisation Materials
Terhi Lehtinen, Senior Medical Officer, Fimea

Discussion

12.10  Lunch

13.10  Pharmacovigilance for Biologicals – GVP PII Biologics
Raphael Van Eemeren, Global Safety Senior Manager, Amgen, Sweden

13.40  Patient Involvement in Adverse Drug Reaction Reporting 
David Lewis, Global Head of Pharmacovigilance, Novartis Pharma AG

14.40  Q&A Session (preliminary questions from the participants in advance: deadline 18.9.)

15.20  Coffee

15.50  Audits and Inspections
Helena Tidlund, Pharmacovigilance Inspector, Drug Inspectorate Industry and Hospital, MPA, Sweden

16.20 EU Data Protection Regulation and Its Impact on PV 
Johan Thörn, Senior Associate and Johan Sundberg, Partner, DLA Piper, Sweden (via Skype)

Discussion

16.50  Conference Wrap-Up
Jukka Pesonen, Director, Drug Safety (QPPV), Orion Corporation

17.00  End of Conference

Lisätietoja

Anja Isoaho
Koulutuspäällikkö
work (09) 6150 4959
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