| Clinical Trials in Russia and Ukraine: Trends and Regulations |
When: Tuesday, December 8 at 12:00 PM, EST
Venue: Mez Contemporary Mexican, 5410 Page Road, Suite 8, Durham, NC 27703
For more information and free registration please visit http://event.oct-clinicaltrials.com/ |
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| EVENT OVERVIEW |
Join us for a catered Lunch and Learn session to hear experts from OCT Group, a leading regional CRO from Russia, speak about the advantages and the ins and outs of performing Clinical Trials in Russia and Ukraine. You will be introduced to the basics of Clinical Trials in Russia and Ukraine, provided with overview on the regulatory frameworks and standards, as well as a chance to discuss potential challenges and risks in approaching this market and strategies to overcome those risks and challenges. Additionally, an invited guest from US Pharma will share his experience in Clinical Trials in this region from a Sponsor’s prospective.
We will cover the following issues:
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| General overview of the Clinical trials in Russia and Ukraine |
- Health Care System in the region
- Why the region is attractive for Sponsors
- Factors that affect the cost and time effectiveness of the region, general cost comparison across Countries.
- Assessment of the region in terms of data and trial quality
- Analysis of Clinical Trials done in the region – therapeutic areas, Phases, FDA submissions, etc
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| Trends and Regulations in Clinical Trials in Russia and Ukraine |
- Clinical trials regulatory framework
- Clinical trial approval process: application and review procedures, submission package, timelines
- IMP and non-IMP logistics
- Local particularities to be considered during start-up (site contract execution and investigator’s grant, local ethics)
- Local factors affecting study feasibility and timelines
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| Why approaching a local CRO is useful and beneficial in planning and conducting a clinical trial |
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| Clinical trials in Russia from the perspective of an experienced US sponsor |
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Who Should Attend?
| • Biotech and pharmaceutical companies |
| • CROs |
| • Heads and VP/Director/Manager level of: |
- R&D
- clinical development
- clinical operations
- project management
- regulatory affairs
- Outsourcing/Procurement
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