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
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.