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Best Practices for Medical Information Global Response Documents from phactMI and MILE
Susan Wnorowski1, Faith Niemoller2, Anja Glaetzer3
1Ipsen, Hillsborough, NJ, USA.
Pharmaceutical Medicine
|January 20, 2026
Summary
Global response documents (GRDs) provide harmonized, evidence-based medical information for healthcare professionals. Best practices were developed by experts to enhance the creation and management of these crucial scientific response documents.
Area of Science:
- Pharmaceutical industry
- Medical affairs
- Scientific communication
Background:
- Medical information departments in pharmaceutical companies respond to healthcare professional inquiries.
- Global response documents (GRDs) are vital for harmonizing information between global and local teams.
- Challenges exist in developing and maintaining GRDs.
Purpose of the Study:
- To establish consensus-based best practices for the creation and management of GRDs.
- To address challenges in GRD development and harmonization.
- To provide guidance for pharmaceutical companies on GRD optimization.
Main Methods:
- An international expert panel from 11 pharmaceutical companies was convened.
- Discussions and deliberations occurred over several months.
- Consensus was achieved through a structured survey with a 75% approval threshold.
Main Results:
- Best practices for GRD development were established.
- Insights on optimal document structure and format were provided.
- GRDs are exclusively for healthcare professionals, focusing on single topics and label-agnostic information.
Conclusions:
- GRDs are essential tools for providing accurate, evidence-based responses to healthcare professionals.
- Best practices ensure GRD relevance, accuracy, and compliance.
- GRD development is a collaborative approach supported by metrics and updates.
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