EMA and US FDA launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible.
The aim of the workshop is to discuss between Regulators and Industry technical quality challenges and scientific and regulatory approaches that could be used to facilitate development and preparation of robust Chemistry, Manufacturing and Controls (CMC) data packages, enabling timely access to medicines whilst providing assurance that patient safety and product quality are not compromised.
Specific industry case studies (covering chemicals, biologicals and ATMPs) and experiences to date across different regions will be discussed. The workshop conclusions will be captured in a report. Development of further follow-up guidance may be considered. People interested in participating are invited to register by 31 October 2018. Due to limited space EMA will allocate places on specific criteria. More details on the workshop can be found in draft agenda.