Regulatory Affairs in Pharmaceutical industry I RA department l Interview questions and answers
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- čas přidán 22. 10. 2023
- Regulatory Affairs in Pharmaceutical industry I RA department l Interview questions and answers
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3. QC - Quality Control in Pharmaceutical industry : • QC - Quality Control i...
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Questions covered:
Q. What is the responsibility of Regulatory Affairs (RA) department of a pharmaceutical company?
Q. What is the role of regulatory affairs in pharmaceutical R&D ?
Q. Which are the top 10 regulatory agencies in pharmaceutical industry ?
Q. Which activities RA regulates ?
Q. What is orange book ?
Q.: What is 180 day exclusivity ?
Q. What are DMF and their types ?
Q. What is NDA and ANDA filing ?
Q. What is difference between law and regulation in pharmaceutical industry?
Q. What is difference between regulated market and non-regulated market ?
Q. What is technical pack ?
Q. What is CTD and eCTD?
Q. Describe the Drug Master File (DMF) and its purpose ?
Q. What is a Certificate of Pharmaceutical Product (CPP)?
Q. Explain the role of a Regulatory Affairs Specialist in the product development process ?
Q. What is an Investigational New Drug (IND) application?
Q. What is a Bioequivalence Study, and when is it required ?
Q. How do you handle the submission of a Variation to an existing marketing authorization?
Q. Explain the Orphan Drug Designation and its significance ?
Q. How does a change in manufacturing processes affect regulatory submissions ?
Q. Describe the role of regulatory affairs in ensuring the compliance of labeling and packaging ?
Q. How does the ICH (International Conference on Harmonisation) impact global regulatory affairs?
Q. How does the Hatch-Waxman Act impact regulatory affairs?
Q. What is a Common Technical Document (CTD)?
Q. What are post-marketing surveillance and pharmacovigilance?
Q. Explain the concept of Quality by Design (QbD) in pharmaceutical manufacturing ?
Q. What is the role of regulatory affairs in the approval of clinical trial protocols ?
Q. How do you address post-approval changes for a marketed drug?
Q. What are the key considerations for regulatory affairs professionals when managing a pharmaceutical product's lifecycle?
Q. Which are the top 10 Global regulatory guidelines in the pharmaceutical industry ?
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Keywords to find this video:
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Hi,sir according to my knowledge Malta counsolate in Pakistan didn't work on visas so that's why we have need to move Abu Dhabi for visa process is it's true
Yes
Pl share on Risk Assesment & ISPE guidelines
I will share.
Gud
Thanks
Thanks for sharing, good information
Thanks
Type III DMF is for packaging materials and Type IV is for excipients.
Thanks for update👍