B.Pharmacy 7th Semester All Subject Notes & Important Question Answer

B.Pharma VIIIth Semester Pharmaceutical Regulatory Science Important Topics With  All The Important Question And Answer Are Publish Here Download the Pdf and Give boost To Your Preparation. Stay Connected with us for your future examination all the important content will publish here . Your Full Pharmacy Syllabus will Be published here.

B.Pharmacy 8th Semester Pharmaceutical Regulatory Science Notes 

Pharmaceutical Regulatory Science - Unit 1

• Introduction to Regulatory Affairs

• History and evolution of regulatory agencies

• Role of regulatory affairs department

• Regulatory authorities and organizations: USFDA, EMA, CDSCO, MHRA, TGA, ICH, WHO, WTO

• Origin and objectives of drug regulations

• Overview of regulatory affairs function

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B.pharma 8th Sem Pharmaceutical Regulatory Science Unit 1 Important Topics PDF:- Click Here

Pharmaceutical Regulatory Science - Unit 2

• Regulatory approval process: IND, NDA, ANDA

• Drug registration process in India

• Clinical trial application: Types, contents, format

• Overview of ICH guidelines

• Orphan drugs and exclusivity

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B.pharma 8th Sem Pharmaceutical Regulatory Science Unit 2 Important Topics PDF:- Click Here

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Pharmaceutical Regulatory Science - Unit 3

• Drug Master Files (DMFs): Types, format and contents

• Common Technical Document (CTD): Modules and contents

• eCTD submissions

• Asian Common Technical Document (ACTD)

• Regulatory requirements for registration of drug products in US, EU, and Japan

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B.pharma 8th Sem Pharmaceutical Regulatory Science  Unit 3 Important Topics PDF:- Click Here

Pharmaceutical Regulatory Science - Unit 4

• Regulatory requirements for biological products and medical devices

• Regulatory considerations for combination products

• Intellectual property rights (IPR): Patents, trademarks, copyrights

• Patent application procedure and guidelines

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B.pharma 8th Sem Pharmaceutical Regulatory Science Unit 4 Important Topics PDF:- Click Here

Pharmaceutical Regulatory Science - Unit 5

• Clinical trials: Definitions, phases, protocols

• Ethics committees: Roles and responsibilities

• Informed consent process

• Good Clinical Practice (GCP) guidelines

• Pharmacovigilance: Definitions, ICSR, PSUR

• Safety reporting

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B.pharma 8th Sem Pharmaceutical Regulatory Science Unit 5 Important Topics PDF:- Click Here

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B Pharmacy 8th Semester Notes 

• Pharmacovigilance
• Biostatistics & Research Methodology
• Social & Preventive Pharmacy
• Pharmaceutical Marketing Management
• Pharmaceutical Regulatory science
• Quality Control & Standardization of Herbals
• Computer Aided Drug Design
• Cosmetic Science

B.Pharmacy 8th Semester All Subject Notes:- Click Here

B.Pharmacy 7th Semester All Subject Notes & Important Question Answer

आप यहाँ से Pharmacy 8th Semester Pharmaceutical Regulatory Science के सभी महत्वपूर्ण नोट्स पढ़ सकते हैं। किसी भी तरह की सहायता के लिए हमसे संपर्क करें:- airadhenotes@gmail.com

Special Thanks And Credits To Carewell Pharma, Pharmdbm and Pharmaedu.

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