Module 1 2021

25/06/2021

 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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Practical Aspects - Personal Experiences … Major Variation – new additional manufacturing site incl. TT and process improvement (challenge: CMO)

• Two step approach: first EU, followed by ROW • Straight forward approach • Clear regulatory environment

During ongoing procedures – change of key documentation with global regulatory impact Hurdles: • Change was not considered in initial assessment/ planning • No link made between different Change Controls and related regulatory assessments • Regulatory assessed changes independently (not considering the overall picture

Consequenes: • Incorrect RA assessments • Delayed implementation

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

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