Regulatory Affairs

Regulatory Affairs Interview Questions and Answers

Updated 31 Mar 2022

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Q1. Difference between eudmf and usdmf

Ans.

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

Ans.

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....

Ans.

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

Ans.

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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