Module 1 2021

25/06/2021

 Risk Management: potential risks need to be well understood to act accordingly  Avoid  Transfer  Mitigate  Accept Common risk factors:  Spare SA on the benefit of time  Generation of data: at minimum costs versus minimize time  Submission of insufficient data packages vs strategic considerations  Communication - share information, updates required (regular core team meetings – Minutes!) Practical Aspects - Some recommendations…

 Kick Off meeting  Lessons Learnt

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

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 Change of RA and/ or competitor environment  Tight timelines & unforeseen issues (tech/scientific) Availability of key team members!  Global Picture  Budget limitations  Resource constraints/ change of key decision takers  Missing documentation of key decisions  Lack of communication/ Miss-alignment  Missing prioritization  Missing skills  Personal situation  Agile: requires shift of mindset & framework (whole company) o Acceptance of not knowing everything at the start of the project o Developing/ learning on a iterative and incremental basis o Evolving solutions of overtime Practical Aspects - Common Difficulties …

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

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