Kinesys and our collaborators Dr Philippe Motte, Dr Xavier Luria and Manon Dutouya, are delighted to publish in TOPRA Regulatory Rapporteur an insightful article on the current status and potential improvements for Early Access Programmes for new drugs in Europe.
Since 2014, there has been a welcome recognition within Europe of the need for improved regulatory mechanisms whereby medicines being developed to target serious or life-threatening diseases that represent an unmet clinical need can be made available to patients at
Kinesys' Gerry McGettigan and Oncobiologics' Liz Yamashita give their views on changes in regulatory and commercial aspects of Biosimilars affecting Asia, Europe and USA. To Download the Article - Click here
A handy guide to the practicalities of working in Regulatory Affairs in a biotechnology company. To Download the Handbook - Click here