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PREPARATION OF SUBMISSION CHECKLIST OF IMPD FOR EU SUBMISSION

Review the latest guidelines for IMPD submissions in the EU.

Confirm the format and requirements for the electronic submission (e.g., eCTD).

Ensure all documents are in the correct language (English or local language as required).

Prepare the cover letter including submission details and contact information.

Compile the list of all investigators involved in the clinical trial.

Include a summary of the overall clinical development plan.

Provide a comprehensive description of the drug substance.

Include the drug product specifications and manufacturing process.

Attach certificates of analysis for all active ingredients and excipients.

Summarize the pharmacology, toxicology, and pharmacokinetics data.

Include relevant animal study reports and findings.

Ensure all preclinical studies are compliant with GLP guidelines.

Prepare the clinical trial protocols and investigator brochures.

Include summaries of previous clinical trial results.

Provide detailed safety and efficacy data from previous studies.

Develop and include a Risk Management Plan (RMP) as per EU requirements.

Identify potential risks and proposed mitigation strategies.

Ensure the RMP is aligned with the data provided in the IMPD.

Include any additional documents (e.g., patents, literature references).

Attach a list of all abbreviations used within the submission.

Verify that all documents are properly referenced and organized.

Conduct a final review of the entire submission for completeness and accuracy.

Ensure all signatures and approvals are obtained from relevant stakeholders.

Submit the IMPD through the appropriate EU submission portal before the deadline.

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