The role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants (DOACs)

• Date:
  Monday, 23 November 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This EMA workshop will bring together experts and stakeholders to discuss the utility of pharmacokinetic (PK) and pharmacodynamic (PD) measurements in the clinical use of the new direct oral anticoagulants (DOACs) and whether those could enhance the benefit-risk profile of these medicines by further reducing the risk of major bleedings while maintaining or improving the protection against thromboembolic events. The objectives of the workshop are to improve the understanding of the clinical use of DOACs, issues in relation to PK and PD measurements as well as priorities in future research.

Documents

Programme - Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Reference Number: EMA/681537/2015

Workshop - the role of pharmacodynamic and pharmacokinetic measurements in the use of direct oral anticoagulants: Background document

Reference Number: EMA/746962/2015

Proceedings of the workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Reference Number: EMA/803589/2015

List of participants - Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Reference Number: EMA/772047/2015

Presentation - DOACs: the patient perspective (Christine Dehn)

Presentation - Challenging patients on DOACs and need for monitoring (Menno Huisman)

Presentation - Management of DOAC in clinical praxis (Peter J Svensson)

Presentation - What can we do now and what are the gaps in our knowledge? The direct thrombin inhibitor (dabigatran etexilate) (Marie Louise S. Christiansen)

Summary:

Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Presentation - Session 2: What can we do now and what are the gaps in our knowledge? The direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) (Antonio Gà³mez-Outes)

Summary:

The role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants (DOACs)

Presentation - Session 3: the analytical part - Measuring the concentration of the direct thrombin inhibitor (dabigatran etexilate) (Franà§ois Mullier)

Summary:

Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Presentation - Measuring concentrations of Rivaroxaban, Apixaban, Edoxaban: methods and challenges (Steve Kitchen)

Summary:

Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Presentation - NOAC future perspectives: academic perspective (Hugo ten Cate)

Summary:

Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Presentation - Future perspectives: how to better use the available data, how to fill the gaps in our knowledge about PK/PD, future ways on how knowledge can be obtained (Jà¶rg Kreuzer)

Presentation - Industry perspective: Bayer/Janssen (Scott D. Berkowitz)

Presentation - Industry perspective: Pfizer - Eliquis® (apixaban)

Summary:

Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants

Presentation - Session 4: future perspectives - What could be done? Industry perspective (Daiichi Sankyo)

Multimedia