Pre-Conference Focus Day
Tuesday, 25th June
8:30 am Morning Welcome Coffee
9:20 am Chair’s Opening Remarks
09:30 am – 12:30 pm | Workshop A
Distinguish the Regulatory Expectations Regarding Post-Emergency Situations & Impact on Quality Control for the Streamline of Your mRNA Therapeutics
Synopsis
In recent years, mRNA-based therapies have shown remarkable promise in treating a wide range of diseases, from cancer to genetic disorders. However, one of the key challenges in realizing the full potential of these therapies lies in efficient regulatory guidelines. This workshop offers a deep dive into the evolving regulatory landscape surrounding mRNA therapeutics and its consequential impact on quality control practices. Participants will engage in lessons learned from mRNA in the COVID-19 era.
Join this session to discuss:
- How has the regulatory landscape evolved post-emergency situations, focusing on changes in expectations for mRNA quality control and compliance
- What are the strategies adopted by organizations to meet evolving requirements
- How can we use lessons learned and apply this to future vaccine and therapeutic development
12:30 pm Morning Break & Networking
01:30 pm – 04:30 pm | Workshop B
Discussing Optimal Documentation Curation & Management for Efficient Creation & Reproducibility of Your QC Testing to Enhance Development Processes & Regulatory Compliance for Your mRNA Therapeutics
Synopsis
As we navigate the intricacies of developing and producing mRNA-based treatments, the accuracy, accessibility, and compliance of our documentation play a pivotal role in ensuring regulatory adherence, reproducibility, and ultimately, the efficacy of our therapeutic interventions. Join us as we delve into the strategies, best practices, and
innovative approaches to curate and manage documentation effectively, providing you
with the tools to optimize your mRNA therapeutic development journey.
Join this session to discuss:
- What is the critical role documentation plays in the development and production of mRNA therapeutics
- What are the different categories of documentation in mRNA therapeutics
- What is the significance of traceability and standardization documentation procedures