Risk-based Monitoring Webinars

Risk-based Monitoring Webinars2016-06-12T11:17:56+00:00
@RACT Pro was designed specifically for CRO, Pharma, Biotech and Medtech enterprises transiting to risk-controlled strategies and processes to meet ICH E6 (R2) compliance.

- What levels of risks exist?
- Why @RACT covers study-level ones?
- Features of @RACT
- Improvements of risk-assessment questions
- How to remain objective by assessing risks?
- Tips and tricks by using @RACT
- Risk identification module  (with automated and self-learning suggestions library)
- Risk assessment module
- Risk mitigations module (with automated and self-learning suggestions library)
- Various risk-assessment questionnaire catalogs (TransCelerate RACT, Cyntegrity RACTs, etc.)
- Versioning of risk assessment changes with audit trail
- Downloadable Excel reports
This webinar will take place on 21st Feb 2019 at 04:00 pm.
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Hear first-hand from the GenesisCare research team how to establish a daily practice of risk management in Oncology trials.

National Research Quality Lead, Bianca Karle, and National Research Manager Oncology, Sophie Mepham, will share their real world experience with cloud-based risk management.

We asked Bianca and Sophie:
- Regarding the practical implementation of a risk-based approach as described by the latest regulatory guidance (GCP, FDA, EMA);
o What motivated your organisation to adopt this approach?
o How did you start and where are you now?
- How does modern technology serve your organisation in this transition?
o What were your considerations to start using @RACT-Pro?
o How does @RACT-Pro fit your way of working?
- How does your organisation use @RACT-Pro in its daily routines?
- What are your organisations next steps?
o How will you further roll-out risk-based thinking and working?
o What are some best practices you'd like to share with your peers?

Join Bianca and Sophie, and learn from two clinical research experts about a practical way to implement risk-controlled processes that meet ICH E6 (R2) compliance.
This webinar will take place on 21st Feb 2019 at 11:00 pm.
Details

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