Module 1 2021

25/06/2021

Regulatory Project Management Plan

• Ensure access for the core & extended team • Clear information, concise & understandable • Point out dependencies – refer to list of deliverables & timelines • Up to date “template” • Project team involved & updated & responsible & accountable • Project governance structure incl. R&R

23

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

23

Little Excursion …

Agile vs traditional/ predictive Project Management (PM)

Predictive PM for • Definable, clear projects

Agile PM for • Not definable projects • Exploratory → New design, problem solving, not-done- before procedures • High rates of changes, complexity & risk • Simultaneously and parallel steps

• Clear, well understood procedures • Low level of execution uncertainty / risk • Sequential procedural steps

24

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

24

12