Regulatory Affairs
Regulatory Affairs Interview Questions and Answers
Q1. Difference between eudmf and usdmf
EUDMF is for EU market and USDMF is for US market. Both contain information about the quality, safety and efficacy of a drug.
EUDMF is submitted to the European Medicines Agency (EMA) while USDMF is submitted to the US Food and Drug Administration (FDA)
EUDMF contains information about the drug substance and its manufacturing process while USDMF contains information about the drug substance, drug product and its manufacturing process
Both DMFs are used to support the registratio...read more
Q2. Quality management is end reports
Quality management is not just about end reports, but a continuous process of ensuring product quality and compliance.
Quality management involves establishing and maintaining quality systems and processes
It includes monitoring and controlling all aspects of product development, manufacturing, and distribution
Quality management also involves continuous improvement and corrective actions
End reports are just one aspect of quality management, and should be used to inform and impr...read more
Q3. Wt about u U r qualification ECT....
I have a Bachelor's degree in Pharmacy and a Master's degree in Regulatory Affairs. I also have experience in the pharmaceutical industry.
Bachelor's degree in Pharmacy
Master's degree in Regulatory Affairs
Experience in the pharmaceutical industry
Q4. Types of CTD module 1
CTD module 1 is the administrative and prescribing information section of a regulatory submission.
Includes prescribing information, product information, and administrative information
Contains information on the drug substance, drug product, and manufacturing process
May also include information on clinical trials and labeling
Examples of documents included in module 1 are the application form, product information leaflet, and labeling
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