How to Create a Reference Document to Supplement Industry Regulatory Guidance

Time: 9:01 am
day: Pre-Conference Day


In the dynamic and rapidly evolving landscape of mRNA therapeutics, the development of a comprehensive reference document that supplements industry regulatory guidance is a vital tool for ensuring the safe and effective development of these groundbreaking treatments. In order to do so, we can look at the entire process from research and development to clinical trials and post-market surveillance. This includes evaluating the manufacturing process, assessing the safety and efficacy of the therapeutic, and monitoring for any adverse events. Ultimately, a thorough review of standards and regulatory requirements is necessary to ensure that mRNA therapeutics are both safe and effective in protecting public health.

Join this session to discuss:

• The quality issues regarding mRNA therapeutics and how we can overcome them

• What is expected by the regulatory agencies for the clinical and non-clinical requirements

• The regulatory guidelines for CMC’s and manufacturing testing to allow a streamline approval

• The advances of having a platform approach for vaccines to allow a more rapid approval of your mRNA vaccines