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Holiday Inn London Kensington Forum

2016 年 06 月 13 日 8:00 上午 - 2016 年 06 月 14 日 12:00 下午

97 Cromwell Road, London, SW7 4DN, United Kingdom

Post-Authorisation Studies (PAS)

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed.

SESSION 4: CONCERNS OF THE AUDIENCE AND STUDY REVIEW

Session Chair(s)

Michael  Forstner, PHD, MPH, MSC

Michael Forstner, PHD, MPH, MSC

Managing Director, Head of Pharmacoepidemiology Practice

Mesa Laubela-Consulting, Switzerland

Gro  Laier, MD

Gro Laier, MD

PV Expert

Denmark

Participants will be asked to submit questions at least two weeks in advance of the course, which will be addressed in plenum.
In addition, two published studies representing different approaches to PASS trials will be made ready for presentation and discussion. Participants will receive a presentation of the issue, develop and discuss a proposed solution in plenum, thereafter the trainers will present what was actually done.

Speaker(s)

Michael  Forstner, PHD, MPH, MSC

CONCERNS OF THE AUDIENCE AND STUDY REVIEW

Michael Forstner, PHD, MPH, MSC

Mesa Laubela-Consulting, Switzerland

Managing Director, Head of Pharmacoepidemiology Practice

Michael  Forstner, PHD, MPH, MSC

CONCERNS OF THE AUDIENCE AND STUDY REVIEW

Michael Forstner, PHD, MPH, MSC

Mesa Laubela-Consulting, Switzerland

Managing Director, Head of Pharmacoepidemiology Practice

Michael  Forstner, PHD, MPH, MSC

CONCERNS OF THE AUDIENCE AND STUDY REVIEW

Michael Forstner, PHD, MPH, MSC

Mesa Laubela-Consulting, Switzerland

Managing Director, Head of Pharmacoepidemiology Practice

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