A cross collaboration of members participated in a series of meetings to review FDA Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial which was published for public...
Regulatory Strategy members participated in a series of meetings to review EMA Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications which was published for public consultation...
Change control and periodic re-assessment are an essential part of raw-material lifecycle management to maintain a qualified raw material. In addition, accurate and timely information is also required in risk assessment to identify any raw materials that warrant...
