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Workshop Catalogue

Engineering a shared journey towards agreement and a common understanding



Deep Dive Themes

  • Establishing the Clinical Safety TPP - mapping opportunities

  • Developing the Clinical Safety Strategy - a SWOT analysis

  • First in Human Transition - a detailed review

  • Draft #1 of the Investigators Brochure - a systematic synthesis

  • Clinical Trial Protocol Safety Review - a virtual pressure test

  • Designing the Safety Monitoring Strategy - of belts & braces

  • End of Phase I Safety Review - key insights and next steps

  • End of Phase II Safety Review - looking back facing forwards

  • Difficult Safety Data - a diagnostic workup

  • Inspection Preparation - focus on clinical safety¬†

  • Submission Safety Strategy - clarity beyond complexity¬†

  • Safety Data Synthesis Workshop - defining the core messages

  • Dossier Safety Review - screening for gaps and fault lines

  • Signal Evaluation Workshop - coming to robust conclusions

  • Health Authority Questions - response finalization workshop

  • Safety Communication Strategy Workshop - core messages

  • Clinical Safety In-licensing Review - integrating the evidence

  • ...any other themes that you require

Arriving at calm waters

Workshops and seminars are often well-suited to explore new domains and to reach agreement on the path to be taken moving forward.

Usually highly interactive they provide a forum for a shared intellectual journey, where ideas and perspectives are exchanged and tested in a safe space, before their realization or implementation.

Challenges and risks are anticipated and potential issues analyzed and proactively addressed.

Moderation by an independent subject matter expert brings efficiency and effectiveness. The moderator provides structure, keeps the focus and challenges decisions from a broad experience base. The content expertise and ownership rests with the team.

Depending on the scope and complexity of the topics to be covered workshops and seminars may be as short as half a day or extend for several days.