Course

AHRO Masterclass in Pharmacovigilance

Time limit: 90 days
20 credits

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Full course description

Introduction 

 

Course Outcome 

After the course, participants should be able to: 

  • Describe various type of data and how they are used  
  • Describe confidence interval and p-values 
  • Describe how to identify information to perform basic sample size calculation 
  • Describe and interpret simple analysis 
  • Define correlation and simpler linear regression 
  • Understand the value and opportunities of data 
  • Describe randomisation, blocking and power calculations 

 

Course Modules 

  • Preclinical Development to IND 
  • The Economic Perspective 
  • Drug Research & Development 
  • Benefit-risk assessment in drug development 
  • Drug Development, Approval, and Safety 
  • Drug Safety in Pre- and post approval phases.

 

Teaching: The course will be taught through series of online tutorials, online formative exercises, series of podcasts and discussion forums. It is compulsory that student take part in 90% of online tutorials.  Self-directed learning is an essential component of this training. Electronic learning resources will be made available in our VLE.  

 

Learning breakdown: Our online courses combine several elements to create a balanced blend of learning. Learners will be able to learn at their own pace during the week by viewing content, engaged in discussions, and completing assignments. It is expected that on the average, 8 to 10 hours per week is required for a course. 

 

Assessment:  Assessment for this course is based on summative assessment which counts to the module mark. Each summative assessment for a module will be made of 1000 word essays, scientific article of high standard, 15 minutes presentations, and 3000 worded final assignment. 

 

Duration: 12 weeks 

 

Commitment: 8-10 hours per week as follows: 

 
 
 
 
 
 

Activity 
 
 
 
 

Projected time (Hours) 
 
 
 
 

Interactive learning 
 
 

3-4 
 
 
 
 

Discussion 
 
 

1-2 
 
 
 
 

Self-guided Research/Learning 
 
 

1-2 
 
 
 
 

Live sessions 
 
 

1 

 

Eligibility: The course is designed for professionals who want to improve their skills and understanding of pharmacovigilance in clinical trials.