Hello guys, Welcome to Africa's Largest Video Search Engine, and you are watching Regulatory Affairs in Pharmaceutical industry I RA department l Interview questions and answers. and this video is uploaded by PharmGrow at 2023-10-23T05:30:19-07:00. We are just promoting this video only for entertainment and educational purpose only. I hop you like our Video Search Engine. [_ZuaDM6dq04]
| Name | Regulatory Affairs in Pharmaceutical industry I RA department l Interview questions and answers |
| Video Uploader | Video From PharmGrow |
| Upload Date | This Video Uploaded At 23-10-2023 12:30:19 |
| Video Discription | Regulatory Affairs in Pharmaceutical industry I RA department l Interview questions and answers ----------------------------------------------------------------------------------------------- Go to below playlists and search for a topic you want: 1. QMS - Quality Management System in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR 2. QA- Quality assurance in Pharmaceutical industry. : https://www.youtube.com/playlist?list=PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP 3. QC - Quality Control in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT 4. OSD - Tablet Manufacturing in Pharmaceutical industry : https://www.youtube.com/playlist?list=PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T 5. Injectable processing - Injectable processing or Sterile dosage formulation : https://www.youtube.com/playlist?list=PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f ----------------------------------------------------------------------------------------------- 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 ? ----------------------------------------------------------------------------------------------- Keywords to find this video: regulatory affairs,working in regulatory affairs,how to get a job in regulatory affairs,regulatory affairs pharmaceutical,getting a job in regulatory affairs,regulatory affairs in pharmaceutical industry,how to work in regulatory affairs,regulatory affairs career,pharmaceutical regulatory affairs,what is regulatory affairs,drug regulatory affairs,regulatory affairs interview,pharmaceutical industry,regulatory affairs certification ----------------------------------------------------------------------------------------------- Copyright disclaimer: “Any illegal reproduction of this content will result in immediate legal action.” [_ZuaDM6dq04] |
| Category | Science & Technology |
| Tags | regulatory affairs | working in regulatory affairs | how to get a job in regulatory affairs | regulatory affairs pharmaceutical | getting a job in regulatory affairs | regulatory affairs in pharmaceutical industry | how to work in regulatory affairs | regulatory affairs career | pharmaceutical regulatory affairs | what is regulatory affairs | drug regulatory affairs | regulatory affairs interview | pharmaceutical industry | regulatory affairs certification |
