Pre-Conference Workshop Day

Tuesday 29th August 2023

8:00 am Registration Opens & Morning Coffee

Workshop A

9:00 am Understanding Standards & Regulatory Requirements for Analytical Development of mRNA Vaccines to Ensure Safety & Efficacy

  • Camilla Foged Professor, University of Copenhagen
  • Heinrich Haas Department of Biopharmaceutics & Pharmaceutical Technology, Johannes GutenbergUniversität
  • Iulia Oita Chemistry, Manufacturing & Controls Manage, Ziphius Vaccines NV


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

12:00 pm Networking Lunch Break

Workshop B

1:00 pm Benchmarking the Role of Lipid Nanoparticles in Enhancing the Effectiveness of mRNA-Based Therapeutics


Recent advances in medicine have led to the development of mRNA-based therapeutics, which have shown promise in treating various diseases. However, the effectiveness of these therapeutics is limited by their inability to penetrate cell membranes. By using lipid nanoparticles, the effectiveness of mRNA-based therapeutics can be greatly enhanced. In fact, several studies have shown that lipid nanoparticles can improve the delivery and efficacy of mRNA-based therapeutics in vivo. Thus, it is clear that lipid nanoparticles play a crucial role in the development of effective mRNA-based therapeutics.

Join this session to discuss:

  • The latest advances in improving the stability of LNP’s to increase safety and efficiency
  • The latest advances in storage of LNP’s to increase safety and global accessibility
  • The different approaches to screen ionizable lipids to reach a high and efficient endosomal escape and a low immunogenicity
  • Why production of LNPs with specific size and PDI according to the regulatory requirement remains a big challenge in mRNA delivery
  • The most recent research in screening lipids to achieve targeted delivery to different tissues

4:00 pm End of Pre-Conference Workshop Day