Medical Affairs Goals
In your own words, what is the main goal of Medical Affairs?
To ensure that healthcare providers and patients receive accurate and current information.
What is the relationship between clinical operations and Medical Communications?
Clinical teams generate data; Medical Communications translate it for various audiences.
A medical inquiry is any question about an individual's health or disability. Who might submit a medical inquiry to a biopharma company?
Internal teams, healthcare professionals, patients, or caregivers.
Name two types of documents that Medical Writers produce.
Regulatory submissions, journal articles, posters, and educational content.
In your own words, what is the primary focus of Patient Advocacy?
Integrating patient perspectives and amplifying patient voices.
When do Medical Affairs teams become especially important in the product lifecycle?
During later clinical trial stages and post-approval phases.
How can Medical Communications teams be structured (name one of two ways)?
By therapeutic area or by product lifecycle stage (e.g., pre-launch, launch, post-market).
In your own words, what’s the purpose of standard response documents?
To provide accurate, up-to-date answers to common questions about a company’s products.
What’s one audience that receives Medical Writing's content?
Healthcare professionals, patients.
What does HEOR stand for?
Health Economics and Outcomes Research.
What role does Medical Affairs play in post-market?
They gather real-world data, respond to inquiries, and explore new indications.
During which clinical phases are Medical Communications teams typically established?
Phase 2 or 3 clinical trials.
In your own words, why is maintaining a medical inquiry database important?
To track, manage, and standardize responses in a compliant, organized way.
What does Medical Education do for internal biopharma teams during product launches?
Develop training programs for sales and medical teams.
What document is central to Product Strategy development?
The Target Product Profile (TPP).