Module 3 - Strategic case studies in practice

TOPRA TRAINING COURSE MODULE 3

FEBRUARY 2021

OUTLINE PROGRAMME

Approximate Timings

What we will cover

0900-0915 0915-0930 0945-1015

Introduction and aims of the course and our example

Your “wish list” for the course

Quick reminder session: • Module 3, the NTA and baseline eCTDs for OTC products.

1015-1045

Team exercise 1 (breakout groups): A first look at parts of an old dossier / the combination pack • CLUEDO – what is important and what might be missing?

1045-1100 1100-1115 1115-1130

… and feedback

Coffee break

Short tutorial – what the assessors say: • Where do most of the deficiencies occur with M3?

1130-1215

Interactive session 1 (slides and team discussion): Update of an established M3 file • Planning the submission / telling the story • Where do the data come from? • What remains and what is replaced? • What to do if it is unintelligible!

1215-1245

Team exercise 2 (breakout groups): the night / day pack • Key pointers for specific sections of 3.2.P – old and new

1245-1315 1315-1400 1400-1430

… and feedback

Lunch break

Short tutorial – Module 3.2.P.2 for established products • What is important / needed – ICH Q8 Interactive session 2 (slides and team discussion): • Filling the gaps • Additional aspects to think about with combination packs

1420-1500

1500-1515 1515-1530 1530-1615

… and feedback

Coffee break

Team CASE STUDY: • Planning your new M3 / thinking about lifecycle mgt • Where will the data come from?

1615-1630 1630-1640

… and feedback

Follow-up task / close