4.10 (10 Ratings)

ICH Guidelines in Pharmaceutical Landscape

99 599

Description

Pharmastate Academy offers a comprehensive course on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, essential for professionals in the pharmaceutical industry. Established in 1990, ICH aims to harmonize technical requirements for drug registration globally.

This course delves into ICH’s key components, including its Assembly, Management Committee, and Working Groups. We cover ICH guidelines across Quality, Safety, Efficacy, and Multidisciplinary areas, emphasizing their role in ensuring drug safety, efficacy, and quality. Topics include Quality Guidelines (e.g., stability testing and good manufacturing practices), Safety Guidelines (e.g., carcinogenicity and genotoxicity), Efficacy Guidelines (e.g., Good Clinical Practice), and Multidisciplinary Guidelines (e.g., medical terminology and electronic standards).

Learn how these guidelines streamline global regulatory processes, reduce duplication, and enhance public health through effective drug development and management. Perfect for regulatory affairs and pharmaceutical professionals seeking to align with international standards. 

Join us to master the essential ICH guidelines and advance your career in the pharmaceutical industry.

What I will learn?

  • Organizational structure of ICH.
  • Key quality guidelines (Q1 to Q12).
  • Key safety guidelines (S1 to S12).
  • Key efficacy guidelines (E1 to E20).
  • Key multidisciplinary guidelines (M1 to M11).

Course Curriculum

1. ICH Guidelines in Pharmaceutical Landscape

  • 1.1 Objectives
    05:06
  • Quiz: Introduction

2. Structure & Objectives

3. ICH Quality Guidelines

4. ICH Safety Guidelines

5. ICH Efficacy Guidelines

6. Multidisciplinary Guidelines

7. Implementation & Impact of ICH

8. Case Studies

9. Final Assessment

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Course Ratings & Reviews

4.1
Total 10 Ratings
5
3 Ratings
4
5 Ratings
3
2 Ratings
2
0 Rating
1
0 Rating
YP
10 months ago
nice course, good understandings
PD
11 months ago
good
KV
12 months ago
Helpfull course
AK
1 year ago
Very good 👍
Good
DP
1 year ago
A comprehensive ,detailed, knowledgeable and structured course. Good knowledge available for pharmacy students
KM
1 year ago
Very good knowledge platform for the self development
MS
1 year ago
Yes, It's really worth it.
KP
1 year ago
Good. Short description of ICH guidelines
PA
1 year ago
Yes
99 599

Material Includes

  • 8 Learning Videos
  • 9 Quizzes
  • Course Certificate

Target Audience

  • Pharma professionals from manufacturing.
  • QA, QC, and Regulatory Affairs.
  • Students pursuing D.Pharm, B.Pharm, M.Pharm, Ph.D, & Pharm D.

Course Ratings & Reviews

4.1
Total 10 Ratings
5
3 Ratings
4
5 Ratings
3
2 Ratings
2
0 Ratings
1
0 Ratings
YP
10 months ago
nice course, good understandings
PD
11 months ago
good
KV
12 months ago
Helpfull course
AK
1 year ago
Very good 👍
Good
DP
1 year ago
A comprehensive ,detailed, knowledgeable and structured course. Good knowledge available for pharmacy students
KM
1 year ago
Very good knowledge platform for the self development
MS
1 year ago
Yes, It's really worth it.
KP
1 year ago
Good. Short description of ICH guidelines
PA
1 year ago
Yes

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