Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2018
Boosting the development of medicines for children
2 October 2018 - The EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published ...
Posted by Michael Wonder on 19 Jun 2018
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
Posted by Michael Wonder on 19 Jun 2018
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products
19 June 2018 - The EMA published in July 2017 a guideline for first‐in‐human drug studies. ...
Posted 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 24 May 2018
Development of antibiotics for children - towards a global approach
24 May 2018 - Workshop with regulators from EU, Japan and US open for registration ...
Posted by Michael Wonder on 22 May 2018
Working together for people with rare and complex diseases
22 May 2018 - Live broadcast of workshop with European Reference Networks on 29 May. ...
Posted by Michael Wonder on 08 May 2018
Two years of PRIME
7 May 2018 - Driving innovation to where it is most needed. ...
Posted by Michael Wonder on 30 Apr 2018
Update of EU recommendations for 2018/2019 seasonal flu vaccine composition
30 April 2018 - Update to recommendations issued in March 2018. ...
Posted by Michael Wonder on 26 Apr 2018
Updated rules for clinical development of vaccines
26 April 2018 - EMA launches public consultation on revised guideline on clinical evaluation of vaccines. ...
Posted by Michael Wonder on 26 Mar 2018
EU recommendations for 2018/2019 seasonal flu vaccine composition
26 March 2018 - EU advice based on WHO recommendations. ...
Posted by Michael Wonder on 19 Mar 2018
Workshop on paediatric regulation – stakeholders to discuss how to boost development of medicines for children
19 March 2018 - Event to be broadcast live on 20 March. ...
Posted by Michael Wonder on 28 Feb 2018
Europe follows FDA with plans to help early Alzheimer's drugs
28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...
Posted by Michael Wonder on 03 Feb 2018
Strengthened guidance on follow-up and risk management for ATMP developers
2 February 2018 - Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation ...
Posted by Michael Wonder on 31 Jan 2018
How to better apply the paediatric legislation to boost development of medicines for children
31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...
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 ...