Eighth stakeholders forum on the implementation of the pharmacovigilance legislation: Building on two years of operation

• Date:
  Monday, 15 September 2014, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The meeting will allow attendees to discuss the current status of implementation, building on two years of operation of the European Union pharmacovigilance system as well as various on-going EU-wide initiatives. Registration by invitation only.

Documents

Agenda - Eighth stakeholders forum on the implementation of the pharmacovigilance legislation: Building on two years of operation

Reference Number: EMA/449800/2014

List of participants - Eighth stakeholders forum on the implementation of the new pharmacovigilance legislation: Building on two years of operation

Reference Number: EMA/533762/2014

Presentation - Implementation of the pharmacovigilance legislation: Building on two years of operation (Peter Arlett)

Presentation - Two years of operation of the Pharmacovigilance Risk Assessment Committee (June Raine)

Presentation - Strengthening collaborations for operating pharmacovigilance in Europe (SCOPE) (Paul Barrow)

Presentation - Complementary initiatives for public health (Franck Diafouka)

Presentation - Patient reporting update (Franà§ois Houà¿ez)

Presentation - Looking to the future: Use of smartphones and beyond (Mick Foy)

Presentation - Increasing access to adverse drug reaction reports on the web (Steven Le Meur)

Presentation - Post-authorisation safety studies – PRAC experience (Almath Spooner)

Presentation - Update on post-authorisation efficacy studies (Kevin Blake, Jane Moseley, Christelle Bouygues)

Presentation - Projects to deliver better IT systems and business change management (Peter Arlett)

Presentation - Translating regulatory science into better processes (Xavier Kurz)

Presentation - EMA medical literature monitoring (MLM) service (Sabine Brosch)

Summary:

Eighth Stakeholders forum on the implementation of the Pharmacovigilance legislation:

Building on two years of operation - 15 September 2014

Presentation - Strengthening interaction with stakeholders (Marie-Agnes Heine)

Presentation - Patients/healthcare professionals involvement in benefit/risk assessments (Nathalie Bere)

Presentation - Experience in benefit risk referral procedure – Combined hormonal contraceptives (Hildrun Sundseth)

Presentation - Towards rules of procedures for public hearings (June Raine, Monika Benstetter)

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