Hello Dear Friends, How are you all, hope you are doing well, today in this article we are going to tell you how you can download Pharmaceutical Regulatory Science B.Pharma 2nd Semester Notes Download Free PDFs for free. Friends, you will also get to see PDF and download links of B.Pharmacy 8th Semester Handwritten and Standard Notes in this article.
According to the syllabus of 2023 by PCI (Pharmacy Council of India), you will get the link to download all the handwritten and standard notes, you get the option to download all the notes semester wise or unit wise.
Pharmaceutical Regulatory Science B.Pharm 8th Semester Information:
|Semester Year||8th Semester|
|Notes Types||Handwritten & Standard Notes|
|PCI Syllabus Notes||Latest PCI 2023|
|Subject Name||Pharmaceutical Regulatory Science|
|Telegram Group Link||Join Us|
|Official Website PCI||www.pci.nic.in|
Note:- Friends, on this website all types of information like – B.Pharma and D.Pharma All Subject PDF Free Notes, Semester Wise Note, Latest Syllabus 2023 and Exam Pattern 2023 Download, Previous Year Question Paper PDF Download etc.
Also Read : B Pharm 1st Semester Notes Free PDFs Download
Pharmaceutical Regulatory Science Syllabus 2023 Pdf Download
Let us see what is in the syllabus of Pharmaceutical Regulatory Science.
1. New Drug Discovery and development
- Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
1. Regulatory Approval Process
- Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved NDA / ANDA.
2. Regulatory authorities and agencies
- Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications)
1. Registration of Indian drug product in overseas market
- Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)research.
1. Clinical trials
- Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee – formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance – safety monitoring in clinical trials
1. Regulatory Concepts
- Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
|B.Pharma Syllabus 2023||Download Link|
|B.Pharma A to Z Semester Syllabus PDF||CLICK HERE|
|B.PHARMA 1ST SEMESTER NOTES PDF||DOWNLOAD LINK|
|Human Anatomy And Physiology-1||CLICK HERE|
|Pharmaceutical Analysis||CLICK HERE|
|Pharmaceutical Inorganic Chemistry||CLICK HERE|
|Communication SkillS||CLICK HERE|
Download free Pdf of notes of Pharmaceutical Regulatory Science
You can download free Pdfs of Pharmaceutical Regulatory Science Standard Notes by clicking on the download links given below table.
|Standard Notes||Download Link|
You can download free Pdfs of Pharmaceutical Regulatory Science Handwritten Notes by clicking on the download links given below table.
|Handwritten Notes||Download Link|
Disclaimer – It is a list of links that have already been downloaded from the internet; we are not maintaining any content that is protected by copyright on our servers. Please review our DMCA Policy. If you believe that we have violated your copyrights, please contact with us right once at firstname.lastname@example.org. The infringing content will be removed within 24 hours.