ICH M10 implementation: global execution and future considerations
On June 8 2022, the ICH published the final guidance of ‘Bioanalytical Method Validation and Study Sample Analysis’, which integrates the practices of health authority bioanalytical regulations from around the world into a single standard, making it much easier for bioanalytical work to be performed and meet global regulatory expectations. On July 25 2022, the European Union adopted this guidance with an effective date of January 21 2023 and the US Food and Drug Administration (FDA) issued final guidance and immediate effect on November 4 2022.
Since the initial ICH publication in June, Labcorp Bioanalytical Services (NC, USA) has been assessing regional standards against the new ICH M10 guidance, developing global transition and change management plans and has completed the transition to be fully compliant with ICH M10 on January 21 2023. This webinar will discuss the complexities of the global transition to ICH M10, key learnings and look to the future as to anticipated changes not yet covered by ICH M10 and how Labcorp Bioanalytical Services is preparing for the future.
What will you learn?
- Key global regulatory change management practices for ICH M10
- Learnings throughout the implementation
- Anticipated bioanalytical regulatory future landscape changes
Who may this interest?
- Pharma and Biotech clients working to navigate ICH M10 changes
- Bioanalytical scientists also working to implement ICH M10
- Individuals working in the regulated bioanalysis space
Speaker
Mark O’Dell
Associate Director of Global Operations, Immunochemistry
Labcorp Drug Development (IN, USA)
Mark O’Dell has more than 18 years of experience working at bioanalytical CROs in a scientific role. He has experience in immunoassays, development and validation, regulatory and study support. At Labcorp Bioanalytical Services, Mark serves as the Global Lead for the Immunochemistry Lead Scientists and supports global execution of initiatives and consultation with clients on scientific and regulatory questions related to ligand-binding assays.
Additionally, Mark participates in AAPS, WRIB and GCC in order to establish and maintain strategic client relationships. Mark received his MA in biology/biotechnology from Washington University (MO, USA) and his BA in microbiology from South Illinois University (IL, USA). Mark has several publications in prominent journals, including the Journal of Neuroscience.
This webinar was recorded on Thursday 16 February 2023.
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