Thank you to our speakers, sponsors, and delegates who joined us in June for the summit! If you are interested in the 2025 event, please get in touch:
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
Welcome to the 2nd mRNA Quality Control & Compliance Summit: Ensuring Regulatory Adherence 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 returned 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.
We reunited industry experts in quality control, quality assurance, analytical development, and CMC, from the likes of CureVac, Intellia Therapeutics, Zipcode Bio, Tessera Therapeutics. We navigated tangible best practices towards optimized documentation, discussed verification processes for platform methods and navigated method validation to develop high quality, durable and effective therapies that have better chance of approvals.
Who Attended in June?
At this leading forum, industry experts navigated 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 |
2024 Expert Speakers
Key Sessions For 2024
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
The Use of Risk Assessment to Evaluate the Quality Impact of Raw & Starting Materials Used in mRNA Manufacturing
Angel Tai, Quality Assurance Manager, Sanofi
New Statistical Approaches to Enhance Stability Data Interpretation
for Innovative mRNA Therapeutics to Ensure Adherence to Regulatory
Guidelines & Expectations
Hossam Samy, Associate Director, Quality Control, Alnylam
Addressing the Need for Quantitative Potency Testing for mRNA Vaccines to Enhance Efficacy & Quality of Your mRNA Medicines
Sarah Hymbaugh, Senior Scientist, Seqirus Inc.
Diving into Method Validation Challenges & Ensuring Manufacturing Consistency in mRNA Production
Yuqing Chang, Associate Director, In vivo LNP QC Lead, Beam Therapeutics
Our 2024 Partners
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
