Understanding Standards & Regulatory Requirements for Analytical Development of mRNA Vaccines to Ensure Safety & Efficacy
Time: 9:00 am
day: Pre-Conference Workshop Day
Details:
Reviewing standards and regulatory requirements is critical for mRNA vaccines. 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 vaccine, and monitoring for any adverse events. Additionally, it’s important to consider the ethical implications of vaccine distribution and ensure that access is equitable. Ultimately, a thorough review of standards and regulatory requirements
is necessary to ensure that mRNA vaccines are both safe and effective in protecting public health.
Join this session to discuss:
- The quality issues regarding mRNA vaccines 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 and manufacturing testing to allow a streamlined approval
- The advances of having a platform approach for vaccines to allow a more rapid approval of your mRNA vaccine
