An inspection from the FDA can pop up at any time throughout a clinical trial pipeline, and being prepared is key. The industry must move toward innovative methods and utilize new technologies to ensure compliance in a global environment. Change your inspection readiness strategy into one that is proactive and preventative, instead of one that is mainly concerned with putting out fires. Developing effective strategies for risk management through careful vendor selection and oversight, expert knowledge of FDA guidances, budget management, and TMF and pharmacovigilance audits will put your organization ahead of the pack.
The 3rd European Clinical Trials Inspection Readiness Summit is designed to explore best practices for developing and maintaining compliance at clinical trial inspection sites. Delegates will leave the event armed with strategies regarding partner oversight, metrics, data quality, TMFs and risk assessment tools. Additionally, this event will provide opportunities for sharing best practices and networking across all contributors and stakeholders, including sponsors, regulators, CROs and project teams.
Top 5 Reasons to Attend for 2017:
1. Review crucial information and analyze regulations from around the world, with a focus on FDA, EMA, PMDA and MHRA regulations
2.Benchmark the success of your clinical trial using metrics that measure the performance of CROs and trial sites
3. Learn strategies for ensuring there is a comprehensive clinical trial storyboard so inspectors can recreate the trial
4. Leverage process maps that can be applied to streamline TMF management and the key team members who need to be involved
5. Innovate your inspection readiness SOPs to arm them with information on risk-based modeling for inspection readiness
Schedule:
8:00 am - 5:00 pm
| Contact Person: | Camille |
| Title | Venturina |
| Contact Email | cventurina@exlevents.com |
| Organizer State/Province: (Outside US) | |
| Organizer Country | Data not provided |
| Organizer Phone | +1917-258-5158 |
| Structural makeup | Data not provided |
| Host Sponsor; Other Sponsors | ExL Events |
| Event sold out? | No |
| Multiple locations or dates? | No |
| Statistics available for most recent event held in: | NA |
| Average number in event attendance of: | |
| Range: | |
| Number in attendance of: | |
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| Target Boundaries | Local |
| Is Registration contact information the same as Organizer Contact above? | Yes |
| Web Page | https://go.evvnt.com/107698-1 |
| Can one register for your CE on your web site? | NA |
| Can registration be made by snail (regular) mail? | Yes |
| Online housing reservations: |
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| Do you have additional written or AV materials for sale? | No |
| If so, are they available for non-attendees as well as those attending? | NA |
| Is full tuition necessary to ensure registration? | No |
| Will there be shuttle service available? | NA |
| Additional notes: | Brochure: https://go.evvnt.com/107698-2 |