Part-1। Pharmaceutical regulatory science 8th sem important questions। Short & long Questions।

Hey! My name is Shahruddin Khan Today In this video I provide Pharmaceutical regulatory science B Pharm 8th semester important questions Short & long questions with solution PDF. Check other subjects Important questions of B Pharm 8th semester 👇    • B Pharm 8th semester important questions   Copyright disclaimer under section 107 of the copyright act 1976, allowance is made for ”fair use” for purposes such as criticism,comment ,news reporting , teaching,scholarship and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational and personal use tips the balance in favor of fair use. Follow on Instagram:- (Personal)   / shahruddinkhan921   Follow on Instagram:- (Channel)   / pharmacy_wala   / Like Facebook Page :- https://www.facebook.com/profile.php?... ___________________________________________ Join Telegram channel link 👇 •●◉✿Pharmacy wala✿◉●• It is official telegram account of Pharmacy wala channel (shahruddin khan) Join this. https://t.me/pharmacywala15M Join whatsapp group👇 https://chat.whatsapp.com/ElxPp2Dt1a6... ____________________________________________ #importantquestions #regulatory #biostatistics #research #bpharmacy #8thsemester #syllabus #importantquestions #exam #social #prevention #pharmacovigilance Unit-I 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. Unit-II 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. Regulatory authorities and agencies Overview of regulatory authorities of India, United States, European Union, Australia, Japan, Canada (Organization structure and types of applications). Unit-III Registration of Indian drug product in overseas marketProcedure 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. Unit-IV 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. Unit-V Regulatory Concepts Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book.