CRED Understanding Clinical Development 2024

08/10/2024

Assessors of the Agency

• Pharmacologist, pharmacists, chemists, statisticians, physician etc

• Working in a team – quality, preclinical, clinical

• Focus on consistency

The Organisation for Professionals in Regulatory Affairs

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Approach of the assessment

Know the legislation, guidelines

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• Try to learn as much as possible from the disease – Make own literature review • Read the summary of the Applicant

• Identify possible procedural/scientific issues

• What scientific advices are provided

• Search for comparable assessments

The Organisation for Professionals in Regulatory Affairs

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