Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2018
Building synergy between regulatory and HTA agencies beyond processes and procedures—can we effectively align the evidentiary requirements? A survey of stakeholder perceptions
13 June 2018 - The pathway for bringing a new medicine to the market is dependent on two sequential processes: achieving ...
Posted by Michael Wonder on 30 Jan 2018
The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations.
30 January 2018 - The “Parallel regulatory-HTA scientific advice” procedure allows manufacturers to receive simultaneous feedback from both EU regulators and ...
Posted by Michael Wonder on 15 Nov 2017
EMA to work with stakeholders to improve the product information for EU medicines
15 November 2017 - Stakeholder feedback sought on ongoing electronic initiatives ...
Posted by Michael Wonder on 20 Jul 2017
EU watchdog concerned drug agency EMA may be too close to companies
19 July 2017 - The EMA, eager to accelerate access to promising new drugs, may be getting too cosy with ...
Posted by Michael Wonder on 08 May 2017
Involving patients in discussions on benefits and risks of medicines
8 May 2017 - EMA publishes report on CHMP pilot project. ...
Posted by Michael Wonder on 06 Dec 2016
Twelfth joint EMA/EUnetHTA dialogue meeting
5 December 2016 - The 12th joint meeting between the EMA and the European network for Health Technology Assessment (EUnetHTA) will ...
Posted by Michael Wonder on 22 Jun 2016
EMA and FDA reinforce collaboration on patient engagement
22 June 2016 - New working group established to exchange best practices. ...
Posted by Michael Wonder on 21 Jun 2016
EMA publishes annual report on its interaction with patients, consumers, health care professionals and their organisations
21 June 2016 - The Agency has expanded activities that could involve patients and health care professionals. ...
Posted by Michael Wonder on 10 Jun 2016
EMA celebrates ten years of its patients and consumers working party
10 June 2016 - Join the live broadcast on Tuesday, 14 June from 14:00 to 17:00. ...
Posted by Michael Wonder on 28 Apr 2016
Involving general practitioners in regulatory decisions on medicines
28 April 2016 - EMA workshop with general practitioners and family doctors kicks off strengthened collaboration. ...
Posted by Michael Wonder on 22 Apr 2016
Integrating patients’ views in clinical studies of anti-cancer medicines
22 April 2016 - The EMA has published new guidance on the use of patient-reported outcome (PRO) measures in oncology ...
Posted by Michael Wonder on 15 Apr 2016
Listening to the public’s views on the safety of medicines
15 April 2016 - PRAC adopts rules of procedure on public hearings on selected safety reviews. ...
Posted by Michael Wonder on 14 Apr 2016
Co-operation between regulators and HTA bodies creates synergies
14 April 2016 - The EMA and the European network for Health Technology Assessment (EUnetHTA) published today a report on their ...
Posted by Michael Wonder on 31 Mar 2016
Early dialogue with regulators and HTA bodies
31 March 2016 - Parallel scientific advice at EMA helps to reconcile different data requirements in one development plan to improve ...