Medical Affairs Basics
In your own words, what is the main goal of medical affairs?
What is ensuring accurate and current communication of scientific information to healthcare providers and patients?
This group translates complex clinical trial data into language that healthcare providers and patients can understand.
In your own words, please explain the role of Medical Information.
This function responds to inquiries about products from doctors, patients, and caregivers.
This group ensures that patient perspectives are considered in drug development and beyond.
What is Patient Advocacy?
Describe what the Product Strategy group does in your own words.
This function ensures that medical and scientific insights are integrated into product development and marketing decisions. By aligning medical knowledge with business goals, this specialty ensures products are positioned successfully in the market.
Post-market, Medical Affairs contributes to this type of data monitoring, often referred to as "RWE".
What is real world evidence?
Some companies organize Medical Communications by therapeutic area, while others organize by this product-related stage.
What is the product lifecycle (pre-launch, launch, post-market/phases of clinical trials)?
Unlike typical call centers, Medical Information hotlines are often staffed by people with these backgrounds.
What are scientific or medical backgrounds (e.g., pharmacy, nursing, advanced degrees)?
In your own words, what are patient-reported outcomes?
Surveys and diaries that capture patients’ quality of life or treatment experience are examples of these.
Before a product launches, Medical Affairs often prepares training programs for this internal audience.
Who are sales/commercial teams?
These professionals are usually physicians who provide medical expertise, educate providers, and support post-market studies.
Who are Medical Directors?
Please provide one example of a scientific communication document.
Research papers, medical information responses, conference presentations, press releases, etc.
These documents are created to provide consistent answers to common questions on efficacy, safety, or dosing.
What are standard response documents?
HEOR (Health Economics and Outcomes Research) studies demonstrate that therapies are not only clinically effective but also this.
What is cost-effective?
This key document describes the desired product characteristics, competitive landscape, and strategic objectives.
What is the Target Product Profile (TPP)?