Product Information Summary Review Meeting

Priority Issues and Activities

1. reinforcement of the review system in accordance with the revision of the preparation guideline

  1. Enhancement of Examination Management

    To continue to study the functions of the electronic examination system in order to realize more efficient and effective examinations. In addition, the preliminary meeting system will be enhanced, and review of examination targets will be considered as necessary.

  2. Reinforcement of the examination system

    Reflecting the opinions of external reviewers, such as medical and pharmaceutical experts and the Data Science Subcommittee, we will establish a more advanced review board system and preliminary meeting system from the viewpoint of discussions from the perspective of medical professionals and more accurate communication to medical professionals.

2. promotion of understanding of the preparation guideline

  1. Clarify the rules of the preparation guideline.
  2. Conduct explanatory meetings on the preparation procedures.
  3. Share case studies and modify some of the contents of the procedure through review meeting reports.

3. support in-house review and training systems of member companies

Since the primary responsibility for materials rests with each member company, the Product Information Outline Review Committee will consider measures to support the review by each company.

  1. Consider expanding the tools for internal training of the guidelines.

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