Supporting mRNA Purity, Stability & Raw Material Testing, Submission of Alternative Analytical Methods & Clarifying Documentation Requirements to Ensure Clinical Validation, Reduce Cost Risk & Safeguard Regulatory Approval
June 25-27, 2024 | Boston, MA
Welcome to the 2nd mRNA Quality Control & Compliance Summit: Ensuring Regulatory to mRNA Quality Standards for Streamlined Approval
Regulatory guidelines and existing protocols to govern aspects of mRNA quality during development and manufacturing are still evolving, creating a lack of clarity and consensus amongst the mRNA community. Without a clear path forward, drug developers risk comprising product quality, safety and efficacy, which could hinder progress towards regulatory approval.
The 2nd mRNA Quality Control & Compliance Summit 2024 returns as the sole industry-centred forum dedicated to showcasing technical data and thought-provoking discussions on all aspects of mRNA quality and compliance to equip mRNA leaders with the means to safeguard faster mRNA drug approvals in line with regulatory expectations.
Reuniting industry experts in quality control, quality assurance, analytical development, and CMC, twe will navigate tangible best practices towards optimized documentation, discuss verification processes for platform methods and navigate method validation to develop high quality, durable and effective therapies that have better chance of approvals.
At this leading forum, industry experts will navigate through case-study-led presentations & interactive discussions to:
Uncover Innovative Strategies for Enhanced Raw Material Testing to Expedite mRNA Product Approval Processes
Delve into Advancements in Platform Methods for mRNA Development to Ensure Compliance with Regulatory Standards
Enhance Process Controls and Reference Material Utilization for Informed Decision-Making in Study Definition and Design
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Uncover Innovative Strategies for Enhanced Raw Material Testing to Expedite mRNA Product Approval Processes
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Delve into Advancements in Platform Methods for mRNA Development to Ensure Compliance with Regulatory Standards
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Enhance Process Controls and Reference Material Utilization for Informed Decision-Making in Study Definition and Design |
Expert Speakers
Key Sessions For 2024 Not To Miss
Exploring the Dynamic Nature of mRNA Quality Control Considering Regulatory Strategies for Different Therapeutic Indications to Optimize Regulatory Approval
Monica Dommel, Associate Director Regulatory Affairs CMC, CureVac
Navigating the Use of Risk Assessment to Evaluate the Quality Impact of Raw & Starting Materials Used in mRNA Manufacturing to Mitigate Potential Quality Risks & Streamline Development
Angel Tai, Quality Assurance Manager, Sanofi
Addressing the Innovation in mRNA Formulation to Overcome Stability Challenges & Enhance Your mRNA Vaccines
Hossam Samy, Associate Director, Quality Control, Alnylam
Explore the Concept of Platform Methods in mRNA Quality Control & the Need for Maintaining Validation Status in a Quality Control Environment
Jean Francois Dierick, Strategic Analytical Validation & Lifecycle Lead, GSK
Discussing Optimal Documentation Curation & Management for Efficient Creation & Reproducibility of Your QC Testing to Enhance Development Processes & Regulatory Compliance for Your mRNA
Therapeutics
Craig Martin, Professor, University of Massachusetts Amherst
This niche must-attend event is a deep-dive and detailed forum incorporating insights from leading Quality Control, Quality Assurance, Compliance, CMC, Regulatory, & Analytical experts, seeking to stay at the forefront of the latest insights, recommendations, and information about how to best align with the quality control regulation and documentation requirements for streamlined approved of high-quality mRNA therapeutics & vaccine
