ICH E6 GCP Interactive Workshops

Course1

Course 1 - How to Build a Sponsor Risk Management Program (2 days)

Day 1: Tuesday, March 6, 2018

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

Why Have a Sponsor Risk Management Program?

  • Discuss the need for a sponsor risk management program 
  • Review ICH E6 (R2) updates
  • Discuss the definition of risk.

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 11:15 a.m.

Review the Key Elements for a Successful Risk Management Program

  • Executive engagement
  • What is the role of a stakeholder
  • Recommended structure for a risk management program

11:15 a.m. – 12:00 p.m.

How to Identify Risks at the System and Clinical Trial Level

  • Different types of risks
  • How to identify different types of risks.
    • Work through examples
    • INTERACTIVE EXERCISE Different types of quantitative and qualitative tools to identify risks

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:15 p.m.

Continued – How Identify Risks at the System and Clinical Trial Level

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 5:00 p.m.

How to Evaluate Risks

  • Discuss evaluating risk using Likelihood, Detection, and Impact
    • INTERACTIVE EXERCISE Work through examples
  • Discuss quantitative and qualitative evaluation approach
    • Pros and cons to both
  • INTERACTIVE EXERCISE Review tools

Day 2: Wednesday, March 7, 2018

8:00 a.m. – 8:30 a.m.

Registration/Continental Breakfast

8:30 a.m. – 10:00 a.m.

How to Control Risk

  • Discuss how to develop practical mitigation strategies
  • What is high risk?
  • Know your risk level

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Reviewing and Communicating Risks

  • When to review previously identified risks?
  • Can a risk be closed?
  • Who do you need to communicate with and when?
  • Developing an overall communication strategy for your risk program
  • Over communicating, how to avoid it

12:00 p.m. – 1:00 p.m.

Break

1:00 p.m. – 2:15 p.m.

How to Report Risks

  • Clinical Study Report requirements
  • Re-evaluation of vendors by quality
    • Re-auditing onsite or remotely
    • Frequency of re-evaluation of vendors based on risk

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 4:30 p.m.

Challenges with Risk Programs

  • Stakeholder/Team challenges
  • Executive management challenges
  • Communication issues
  • Lack of agreement with risk scoring

 

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Course 1 | Course 2

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