This e-learning module is intended for any assessor involved in a safety-related referral. It offers practical advice at all stages of the process and should be used in conjunction with other relevant guidance and the EMA templates.
After completing this module learners will be able to:
- Understand and describe the purpose of a safety referral
- Describe the different types of referral procedures assessed by the Pharmacovigilance Risk Assessment Committee (PRAC)
- Understand the key stages in a referral and how you can prepare for them
- Identify steps you can take to make the assessment process as efficient and effective as possible in order to prepare an assessment report of high quality
- Assess a referral procedure with more confidence
What does this document cover?
2. What is a safety referral procedure?
3. Key stages in a referral
4. Other considerations
5. When you’re not (co)-rapporteur
The target audience is primarily pharmacovigilance assessors working at National Competent Authorities.
50-60 minutes completion time.
Click here to access this e-learning module.