General
In your own words, describe the goal of the regulatory affairs department at a biopharma company.
Ensuring companies comply with laws and regulations for drug development and approval.
What is the primary responsibility of Ad/Promo Regulatory Affairs?
Ensuring that all promotional materials comply with regulations while effectively communicating product information.
Name one team outside of the regulatory vertical that Regulatory Labeling professionals may interface with.
Clinical operations, clinical development, drug safety, medical affairs.
What does CMC stand for?
Chemistry, Manufacturing, and Controls
Name two ways that a regulatory affairs department can be organized.
By therapeutic area, geographic location, promotional team, or CMC team.
How do Ad/Promo teams and marketing teams work together?
Marketing develops promotional materials, while Ad/Promo ensures they comply with regulations and align with approved labeling.
What does CDS stand for?
Core Data Sheet
What is the primary focus of Regulatory CMC?
Ensuring that drug production, quality control, and product specifications meet regulatory requirements.
Name three regulatory bodies that a global regulatory affairs department may interact with (along with the country/region they are associated with!).
FDA - US EMA - Europe MHRA - UK, PMDA -Japan, Health Canada - Canada
Name one skill that is crucial for Ad/Promo Regulatory professionals.
Communication, regulatory expertise, attention to detail, or collaboration.
What is the primary purpose of the Core Data Sheet (CDS)?
It serves as a global reference document outlining key safety, efficacy, and usage details of a drug.
How does CMC help ensure product quality and patient safety?
By documenting and validating drug formulation, manufacturing consistency, and quality control measures.