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Workshop will achieve the following:
This highly strategic, introductory workshop will address cost of raw materials, manufacturing challenges and manufacturing activities to support a successful IND/IMPD submission towards initiation of clinical studies for oligonucleotide therapeutics. Participants will gain broad understanding of the regulatory CMC requirements and hurdles for oligonucleotide therapeutics in the US, Europe, Canada and Asia.
Who should attend?
Anyone interested in preclinical/clinical development of oligonucleotide therapeutics including scientists in R&D, manufacturing, quality control, quality assurance, project management, business development and regulatory affairs.
General Workshop Overview: