Day 1 – Wednesday 23rd March

11.00am – 11.05am          Introductions

11.05am – 11.35am          An introduction to safety signals

• History of safety signals
• The nature of safety signals
• The definition of safety signals
• Safety sources for signal detection

11.35am – 11.45am          Q & A

11.45am – 12.15pm          Causality and signal detection

• Causality assessments for signal review
• Data quality in safety assessments
• Causality versus incidence (DMEs and IMEs)
• Generic and innovator products

12.15pm – 12.20pm          Q & A

12.20pm – 12.50pm         The safety review meeting and process

• Setting up a safety review
• Risk determinations for safety review signal trackers
• Information and templates
• Logistical safety and product safety
• Information from safety reviews

12.50pm – 13.00pm         Q & A

13.00pm – 14.00pm          Refreshment Break

14.00pm - 14.30pm         Safety assessments life cycle

• Pre-clinical safety
• Clinical safety
• Class-related safety issues
• Post-marketing safety
• Product suspensions/withdrawals

14.30pm – 14.40pm         Q & A

14.40pm – 15.10pm          The regulatory requirements for signal detection

• The frequency of safety reviews (risk assessment)
• The EU signal detection requirements
• Signal detection and benefit-risk assessments
• The regulators and signals

15.10pm – 15.20pm          Q & A

15.20pm – 15.50pm          Quantitative and qualitative signal detections

• Standard MedDRA queries (SMQs) and signal detection
• ICSRs and case quality
• Follow-up methodology and regulatory requirements
• Events of special interest

15.50pm – 16.00pm          Q & A

Day 2 – Thursday 24th March

11.00am – 11.05am          Recap

11.05am – 11.35am         Quantitative signal analysis

• Signal detection methodologies
• Background – why quantitative signal detection?
• Measures of disproportionality (PRR, ROR, MGPS, BCPNN)
• Regulatory and industry activity (including EudraVigilance)

11.35am – 11.45am         Q & A

11.45am - 12.15pm         The signal review cycle

• Safety profiling
• Signal detection, validation, confirmation
• Analysis and prioritisation, assessment
• Recommendation for action

12.15pm – 12.20pm         Q & A

12.20pm – 12.50pm          Signals and their discussion

• Signals and DSURs
• Signals and PSURs/PBRERs
• Signals and risk management plans/REMs and minimisation
• Signals and labelling

12.50pm – 13.00pm          Q & A

13.00pm – 14.00pm          Refreshment Break

14.00pm – 14.30pm          Safety communication

• The CCSI/DCSI and labelling
• Triaging for safety amendments
• Emerging safety issues
• Urgent safety restrictions
• Product suspension and withdrawal

14.30pm – 14.40pm          Q & A

14.40pm – 15.10pm         EVDAS and the EU

• The PRAC and signals
• The EVDAS system
• Signals arising from EVDAS

15.10pm – 15.20pm         Q & A

15.20pm - 15.50pm         Risk-benefit analysis

• Calculating the extent of benefit by indication
• Identifying significant product risks
• Benefit-risk assessments
• Benefit-risk outcomes

15.50pm – 16.00pm         Q & A