Day 1 – Tuesday 22nd February

12.00pm – 12.15pm          Introductions

12.15pm – 12.35pm          History and rationale for writing periodic safety update reports (PSURs)

12.35pm – 13.15pm          Regulatory aspects of writing PSURs (GVP VII outline)

13.15pm – 13.25pm          Q&A

13.25pm – 13.30pm          Refreshment break

13.30pm – 13.50pm          Core Safety Information

13.50pm – 14.10pm         PSUR data and safety evaluation

14.10pm – 14.15pm         Q & A

14.15pm - 14.50pm         Patient Exposure for PSUR including short exercise, how to calculate and present post marketing patient exposure

14.50pm – 15.00pm         Q & A

Day 2 – Wednesday 23rd February

12.00pm – 12.15pm          Recap

12.15pm – 13.00pm          Process of planning, writing and reviewing a PSUR

13.00pm – 13.15pm          Q & A

13.15pm – 13.20pm          Refreshment break

13.20pm – 14.20pm         Detailed PSUR content (practical explanation for each section)

14.20pm – 14.30pm         Q & A

14.30pm – 14.50pm         Practical exercise (Cover page, report information, product information)

14.50pm – 15.00pm         Q & A

Day 3 – Thursday 24th February

12.00pm – 12.15pm          Recap

12.15pm – 13.00pm          Practical Exercise – evaluation of risk and new information

13.00pm – 13.15pm          Q & A

13.15pm – 13.20pm          Refreshment break

13.20pm – 14.00pm         Benefit-Risk Evaluation, general concept, what to focus on while authoring a PSUR

14.00pm – 14.10pm         Q & A

14.10pm – 14.50pm         DSUR – introduction and content, modular overlap DSUR/PSUR

14.50pm – 15.00pm         Closing remarks