Registration opens for workshop on dose finding at the European Medicines Agency
NewsCorporateMedicines
Registration is now open for a workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicines. The workshop is jointly organised by the European Medicines Agency (EMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) and will take place at the EMA on 4 and 5 December 2014.
The workshop is open to all stakeholders, including industry, academia, regulators and patients' and healthcare professionals' representatives, and will be broadcasted live.
The aim of the workshop is to reach agreement on a toolkit of methods that medicine developers can use for the estimation of the dose-exposure-response relationship and dose finding, and on a decision tree to guide the practical implementation of these methods in medicine development.
As part of the development of a new medicine, dose-finding studies need to be conducted to determine the dose to be administered to patients with the best expected balance of safety and efficacy, which will then be used in confirmatory phase-III trials and once the medicine is on the market. This requires an investigation of the full dose-exposure-response relationship of a medicine. This step is one of the most complex and crucial elements in medicine development and is often insufficiently explored and documented in marketing-authorisation applications received by the EMA.
The workshop will raise awareness of the importance of investigating and understanding the dose-exposure-response relationship as part of medicine development in a systematic way. This not only aims to optimise the chances of successful development and authorisation, but is also essential to improve dose recommendations for patients included in the medicines' summary of product characteristics and for the lifecycle management of the medicines.
Correction: On Monday 23 June 2014 at 16:15 this news item was updated to incorporate a simpler description of the workshop's overall objectives. More detailed information can be found in the agenda for the workshop.