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Recorded Webinar
FDA and EMA successful development and approvals strategy for a biologic
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The webinar will tips and insights on how to succeed in the ever-changingenvironment of biologic medicines including recombinant therapeutic proteins and advanced therapies.
Gain an overview of the Biotech/Biologicsdevelopment- clarifying the latest requirements for regulatory compliance, how to achieve approval andpredicting the effects of changing technologies. Be confident in your cooperation and interchange with EU and US agencies from the outset.
The Webinar will examine industry experience of optimising biotech/biologics drug development:
Submissions avoiding clinical holds and nonapprovals
- Clarify the criteria for submitting successful biotech IND/CTA or MAA/BLA/NDA applications
- Identify the latest regulatory requirements and compliance strategies
- Compare EU and US drug submission procedures
- Leverage latest collaboration between FDA and EMA
- Provide insights into how genomic biomarkers (GBMs) may aid and influence: patient selection, stratification of treatment strategies or patient groups, early evaluation of treatment effect including adverse reactions, and prognosis
- Build validation programmes to support different stages of development
- Be aware of comparability issues phase I, II, III and IV with respect to impact on efficacy, immunogenicity and other safety aspects, and how to address them
- Consider the importance of ‘drug drift’ during development pre- and post-approval
Who should attend
Anyone who is interested in learning more on FDA/EMA Regulations for biologics
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