About the Event
The workshop will provide a deep-dive into the commercial development of cell & gene therapies through global regulatory pathways. In particular, it will highlight commonalities and differences in major regulatory requirements in key markets and provide guidance on how to accommodate or incorporate these to build a more efficient global development program.
Duncan Mackay (Director, Regulatory Affairs, ERA Consulting Ltd UK) will discuss utilising a classic “what, where, why, when, who and how” approach to engage with regulatory agencies to validate and adjust plans in a dynamic environment. He will also explore accelerated pathways and incentives and how to prepare for success in attaining these.
The workshop will be interactive with each session beginning by drawing upon experience, ideas and issues faced by the participants before moving into more formal presentations and finishing with a summary of key learning points. Sessions will be designed to address often overlooked or poorly planned issues such as sourcing, distribution and final product delivery (how to get the therapy to and into the patient).