Registration opens for workshop on EMA-HTA parallel scientific advice in drug development

14 June 2013

The European Medicines Agency (EMA) is inviting expressions of interest in attending its workshop on parallel scientific advice in drug development with health-technology-assessment (HTA) bodies on 26 November 2013.

The workshop will bring together representatives from European regulators, HTA bodies, payers, the pharmaceutical industry, patients and prescribers. The scope and agenda of the event are being determined in collaboration with HTA bodies and developers.

The workshop aims to consider:

• options for parallel regulatory HTA scientific advice, including the EMA-HTA parallel advice process and early dialogue pilots with EUnetHTA, the European Network for Health Technology Assessment;
• lessons learned from the ongoing EMA-HTA parallel scientific-advice process;
• how to optimise the EMA-HTA parallel scientific-advice process;
• the development of best practice for all parties involved (industry, HTAs and regulators) for an optimum outcome of the EMA-HTA parallel scientific advice.

Patients have access to new medicines through a two-step process. As the first step to market access, a new medicine requires a marketing authorisation from a medicines regulatory agency. The second step prior to enabling patient access to a new therapeutic option is the assessment of its usefulness to the healthcare system that lies with a payer or healthcare-guidance organisation, and the HTA bodies that advise them.

It is recognised that some new medicines authorised by the EMA fail to be reimbursed or made available as expected. A major reason for this is that sponsors are not sufficiently addressing the varying evidence needs of payers and healthcare-guidance and HTA bodies in their medicine-development programmes.

Since 2010, the EMA has put in place a pilot project of parallel scientific advice with HTA bodies that allows developers to receive simultaneous feedback from both regulators and HTA bodies on their development plans.

A report on the experience gained so far as well as best practice guidance for all parties involved are the expected outcomes of the workshop.

Expressions of interest should be sent to [e-mail] by 30 August 2013. Places are limited.

The agenda for the workshop will be published shortly.

The outcomes of the workshop and presentations will be published on this website.