Gene therapies and genetically modified organisms face special regulatory challenges for the conduct of clinical trials. This is particularly true for global trials that face a myriad of approval requirements in addition to the regulatory agency and ethics committee approvals. While some countries have a well defined regulatory framework addressing these products, other countries do not and the requirements may be less clear. With an increased emphasis on conducting global clinical trials the investigation of the diverse additional requirements becomes paramount for developing a time- and cost-effective regulatory strategy. The session will provide an overview of requirements for some global countries from an industry professional.
Learning Objective : To recognize and apply the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules towards application of human gene transfer research
To understand the impact of the NIH Guidelines for trials within and external to the United States
To develop and leave with strategies on accelerating study start-up for clinical operations with the NIH Guidelines requirements.