EMA: Can measuring anticoagulant activity and concentration in the body play a role in clinical use of medicines used to prevent blood clots?
Registration opens for public workshop
The European Medicines Agency (EMA) is calling for expressions of interest from experts and stakeholders to attend a workshop on the role of pharmacokinetic and pharmacodynamic (PK/PD) measurements in the clinical use of direct oral anticoagulants (DOACs) scheduled to take place in London on 23 November 2015.
The agenda of the workshop is available.
Expressions of interest should be sent to DOACworkshop@ema.europa.eu by Friday, 30 October 2015, including name, company or affiliation, telephone number and e-mail address.
The objectives of the workshop are to:
- understand problems related to the use of DOACs in clinical practice, in the overall population of patients, in subgroups of patients at particular risk of bleedings or underexposure, and in patients who present with major bleeding or need acute surgery or other invasive interventions;
- understand the need to further guide clinical decision-making on dose adjustment during routine use of DOACs, when major bleedings occur, or when acute surgery is needed;
- develop recommendations regarding PK/PD measurements that can be implemented based on current data;
- identify gaps in knowledge on PK/PD measurements of DOACs;
- explore analytical methods: their validity, availability in the European Union and how they are currently used
- identify priorities for future research in the field of PK/PD measurements of DOACs.
A total of 50 places are available. They will be allocated to ensure a fair representation across all stakeholder groups, including regulatory, patient and healthcare professionals and pharmaceutical industry representatives. Confirmation of participation in the workshop will be sent by 6 November 2015.
The workshop will be broadcast live on the EMA website. A video recording will be made available following the event. Presentations from the workshop will also be published.
Posted on the EMA website on 16 October 2015