News Items
General news item not a press release
Concerted efforts - Closer working between companies’ own departments and between international regulators will streamline the drug approval process
This story was first published in the Jan/Feb 2011 issue of PME - www.pmlive.com
TOPRA congratulates all Regulatory Affairs Awards winners
TOPRA would like to congratulate all the winners of the inaugural Regulatory Affairs Awards, announced on Tuesday 5 October during the Gala Dinner at the TOPRA Annual Symposium.
The winners were judged in the five categories of Innovation, Inspiration, Support, Horizon and Achievement and were presented with their award by Sir Alasdair Breckenridge, chairman of the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Improving medicines access - Regulatory affairs experts to address current and future trends and issues at TOPRA event
The article below was first published in the Sept/Oct 2010 issue of PME - www.pmlive.com
Growing together - Regulatory affairs professionals are finding innovative ways to support drug development
The article below was first published in the Sept/Oct 2010 issue of PME - www.pmlive.com
European Medicines Agency public consultation on ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries
The European Medicines Agency has published a draft 'Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA'.
The document is available on the following webpage:
