Search Results for "www.ich.org/"

PROCESS OF ICH (International Council for Harmonisation)

In this slides contain a ICH guidelines process and information about the organization. https://www....

ICH and Overview of ICH Guidelines..pptx

This presentation gives knowledge on ICH and its History, Mission, and overview of ICH Quality, Safe...

Common Technical Document (CTD)

The Common Technical Document (CTD) is a standardized format for regulatory submission of informatio...

API Starting Material Designation - Where Does cGMP Start?

API Starting Material Designation - Where Does cGMP Start? API starting material designation continu...

Safety pharmacology

Safety pharmacology studies for respiratory, CNS and CVS system

Common Technical Document (CTD)

- Whilst the realization of the CTD took many years, there is now a common format for the submission...

Sop writing for research sites

Sop writing for research sites

Ich

CHANGE CONTROL

THIS PRESENTATION IS ABOUT THE CHANGE CONTROL IN PHARMACEUTICALS

Pharmacovigilance Reporting and Communication: Collaboration between Stakeholders

Effective reporting and communication in pharmacovigilance play a vital role in ensuring the safety ...

Origin and Principle of ICH(GCP) R2.pptx

This SlideShare presentation provides a comprehensive exploration of Good Clinical Practice (GCP) as...

impurities of new drug products based on ICH guidelines(Q3BR2)

IMPURITIES IN NEW DRUG PRODUCTS BASED ON ICH GUIDELINES Q3BR2. Brief note on impurities present in n...

Quality-by-design(QbD) in pharmaceutical development

M.Pharm, 2nd Sem, Pharmaceutics, Computer Aided Drug Development

ICH: Introduction, objectives & guidelines: A brief insight.

This is my 44th powerpoint........deals with ICH guidelines..... Deals with brief introduction, prec...

Introduction to ctd (common technical document)

COMMON TECHNICAL DOCUMENT

Accelerated stability testing

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Quality by design ( QbD)

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Safety Pharmacology.pptx

Safety Pharmacology Tier 1 Study

Abbreviated New Drug Application ANDA ppt

Abbreviated New Drug Application ANDA ppt by Akanksha puri

Drug Regulatory Affairs (DRA)

A brief introduction to Drug Regulatory Affairs and Its Regulatory Authority.

Analytical method validation as per ich and usp

Analytical method validation is a process of documenting/ proving that an analytical method provides...

INTRODUCTION TO QUALITY BY DESIGN (QBD)

INTRODUCTION TO QUALITY BY DESIGN (QBD)

ICH GUIDELINES Q S E M & REGULATORY REQUIREMENTS OF EU, MHRA, TGA & ROW COUNTRIES

ICH GUIDELINES Q S E M & REGULATORY REQUIREMENTS OF EU, MHRA, TGA & ROW COUNTRIES

ICH guidelines

The presentation is intended for B.Pharm Third Year students of PCI Syllabus for subject Quality Ass...