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Course / Course Details

Drug Regulation in Europe

Pharmaceutical

By - Rajashri Ojha
0 students
3 Hours
(0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover Pharmaceuticals in the European Union, History of Drug Regulation in European Countries, Centralized Regulatory Authority of European Union (EU), EUDRALEX: EU Pharmaceutical Legislation, European Medicines Agency (EMA), Regulation of medicines in the European Union, Marketing Authorization, Centralized Procedure (CP), Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP), National Procedure, Types of Variations.

Course Curriculum

1 chapters
7 lectures
0 quizzes
3 Hours total length

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1 Drug Regulation in Europe

15 Min

2 eCTD Guidance

15 Min

3 Q&A on how to handle ongoing procedures in relation to mandatory eCTD format

15 Min

4 Drug Regulation in Europe

1 Min

5 Europe Regulation-Variation video 1

1 Min

6 Europe Regulation-Variation video 2

1 Min

7 Europe Regulation-Variation video 3

1 Min

Instructor

Rajashri Ojha

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11 Students

141 Courses

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Duration 3 Hours
Lectures 7 lessons
Enrolled 0 students
Category: Pharmaceutical
0 Quizzes
Language: English
Skill Level Short Courses
Certificate of Completion
7 Days Access

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