8 September 2016 EMA/348709/2016 Inspections and Human Medicines Pharmacovigilance Division

Draft Agenda – Tenth Stakeholder forum on the Pharmacovigilance legislation 21 September 2016, 09.00-13.00, Room 3/E, European Medicines Agency (EMA) - 30 Churchill Place, Canary Wharf, London, E14 5EU, UK Time

Agenda item

Speakers

08:30 – 09:00 Registration and reimbursement arrangements Session 1 – Pharmacovigilance legislation - what has been achieved and future priorities 09:00 – 09:15

Welcome and Introduction Guido Rasi (EMA)

Session 1 - Co-Chairs: June Raine (PRAC Chair) and Fergus Sweeney (EMA) 09:15 – 10:15



3-year report on Pharmacovigilance

Helen Lee, European Commission

activities •

Scanning the horizon for 2016 – 2018

Peter Arlett, EMA



Activities report from SCOPE (The

June Raine, MHRA, UK

Strengthening Collaboration for Operating Pharmacovigilance in Europe) Joint Action •

Pharmacovigilance Impact – for better

Almath Spooner, HPRA, IE

pharmacovigilance 10:15 – 10:30

Open panel discussion

Session speakers, co-chairs, PCWP representative, HCPWP representative, Representatives from Industry associations

10:30 – 11:00

Coffee break

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Time

Agenda item

Speakers

Session 2 - Regulatory science driving better Pharmacovigilance Session 2 - Co-Chairs: June Raine (PRAC Chair) and Peter Arlett (EMA) 11:00 – 11:30



Turning regulatory science into better

Xavier Kurz, EMA

pharmacovigilance: experience from the PROTECT project •

Harnessing mobile apps and social media for

Philip Tregunno, MHRA, UK

product safety 11:30 – 11:45

Open panel discussion

Session speakers, co-chairs, PCWP representative, HCPWP representative, Representatives from Industry associations

Session 3 - Lifecycle Pharmacovigilance planning for public health Session 3 - Co-Chairs: Almath Spooner (HPRA) and Peter Arlett (EMA) 11:45 – 12:30



Introduction: planning is key to product

Almath Spooner, HPRA, IE

development and safe and effective use of

and Peter Arlett, EMA

products •

Scientific Advice delivers planning during

Spiros Vamvakas, EMA

development •

Epidemiology as an enabler for health

Alison Cave, EMA



Actions from the Risk Minimisation Measures

Jamie Wilkinson, PGEU

Workshop in 2015 12:30 – 12:45

Open panel discussion

Session speakers, co-chairs, PCWP representative, HCPWP representative, Representatives from Industry associations

12:45 – 13:00 Conclusions 13:00

Close of meeting

Draft Agenda – Tenth Stakeholder forum on the Pharmacovigilance legislation EMA/348709/2016

Page 2/2

Agenda - European Medicines Agency - europa.eu

Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. •. Scanning the horizon for 2016 – 2018. Peter Arlett, EMA.

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