Pharma Drug Regulatory Affairs course - DRA
4.5 /5- Offered byUDEMY
Pharma Drug Regulatory Affairs course - DRA at UDEMY Overview
Duration | 8 hours |
Total fee | ₹649 |
Mode of learning | Online |
Credential | Certificate |
Pharma Drug Regulatory Affairs course - DRA at UDEMY Highlights
- Earn a certificate of completion from Udemy
- Learn from 15 downloadable resources
- Get full lifetime access of the course material
- Comes with 30 days money back guarantee
Pharma Drug Regulatory Affairs course - DRA at UDEMY Course details
- For Pharmaceutical industry employees
- For Pharmacy Students & Pharma Professionals
- For Chemistry students
- For Science Graduates
- For Diploma in pharmacy
- For Pharma professionals
- For Students from lifesciences background
- For Regulatory affairs professionals
- Basic concepts Pharma Regulatory Affairs
- Advanced Regulatory Affairs
- How Regulatory Authorities Regulates Drug product
- Career in Regulatory Affairs
- Job opportunities
- eCTD & CTD Structure
- eCTD Modules
- Dossier Preparation & Submission
- Drug master file
- Submission of Drug Master File
- The Pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms
- Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing
- Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug
- This online course helps Pharmacy Students and Professionals to build their knowledge and skills towards career in Regulatory Affairs
- Course is designed to cover all aspects of healthcare product regulations, compliance and standards, giving a global perspective on regulatory affairs
Pharma Drug Regulatory Affairs course - DRA at UDEMY Curriculum
Course Introduction and Overview
Course Overview
Course Contents
Career Opportunities in Regulatory Affairs
Introduction and Objective of Course
Drugs@FDA Database Information
Common Websites and Usage
ICH Guidelines
Literature Survey
Drug Master File
Drug Master File
Difference between DMFs and Applications
Submission of DMF
Common Technical Documents
Module - 1 Administrative (Region Specific)
Module - 2 (Summary & Overview)
Module -3 (Quality) Drug Substance
Module -3 (Quality) Drug product
Module -3 (Quality) Drug product
Module -3 (Quality) Drug product
Stability Study
Module 4 (Non-Clinical Study)
Module 5 Clinical Safety reports Part - I
Module 5 Clinical Safety reports Part - II
eCTD Structure
Basic Demonstration of eCTD Software & eValidator
Insights on IND (Investigational New Drug Appilication)
New Drug Development: USFDA Perspectives
Elements of drug development
What is New Drug?
Insight on Non-clinical testing
Questions and Answers- Non-clinical study
Planning and preparation for FDA Meetings
Overview on IND and FD&C Act
CDER and IND Review Process
Updating of IND Application
New Drug Approval (NDA) & Abreviated New Drug Application (ANDA)
(New Drug Approval) NDA Part - II
New Drug Application (NDA)
Abreviated New Drug Application (ANDA)
Submission for registration process
Introduction to ESG
Overview of Registration Process
Letter of Non-Repudiation agreement
Obtaining digital certificate
Understand submission Guidelines
FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS
Congratulations & Thank you
Congratulations & Thank you
Pharma Drug Regulatory Affairs course - DRA at UDEMY Faculty details
Pharma Drug Regulatory Affairs course - DRA at UDEMY Entry Requirements
- Prerequisite: Requires basics Pharmacy Knowledge
- Not mentioned
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