SlideShare a Scribd company logo
1 of 10
SUMMARY OF SCHEDULE Y By Lekshmi.L.Nair
What is schedule y? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Drugs and Cosmetics Act 1945 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Requirements and guidelines on Clinical Trials for import and  manufacture of  New Drug ,[object Object],[object Object],[object Object],[object Object],[object Object]
1. Application for permission   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2.Clinical Trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
3.Studies in Special Population ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APPENDICES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]

More Related Content

What's hot

What's hot (20)

Schedule Y
Schedule Y Schedule Y
Schedule Y
 
Schedule y
Schedule ySchedule y
Schedule y
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Schedule y
Schedule ySchedule y
Schedule y
 
Schedule Y amendments
Schedule Y amendments Schedule Y amendments
Schedule Y amendments
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...
 
Schedule y
Schedule  ySchedule  y
Schedule y
 
Documentation clinical trial
Documentation clinical trialDocumentation clinical trial
Documentation clinical trial
 
New drugs and clinical trial rules 2019.pdf
New drugs and clinical trial rules 2019.pdfNew drugs and clinical trial rules 2019.pdf
New drugs and clinical trial rules 2019.pdf
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Schedule Y by akshdeep sharma
Schedule Y by akshdeep sharmaSchedule Y by akshdeep sharma
Schedule Y by akshdeep sharma
 
Preparation of Clinical Trial Protocol of India.
Preparation of Clinical Trial Protocol of India.Preparation of Clinical Trial Protocol of India.
Preparation of Clinical Trial Protocol of India.
 
Investigator brochure
Investigator brochureInvestigator brochure
Investigator brochure
 
VOLUME 9A ppt.pptx
VOLUME 9A ppt.pptxVOLUME 9A ppt.pptx
VOLUME 9A ppt.pptx
 
Monitoring of clinical trials
Monitoring of clinical trialsMonitoring of clinical trials
Monitoring of clinical trials
 
ICH-GCP Guidelines
ICH-GCP GuidelinesICH-GCP Guidelines
ICH-GCP Guidelines
 
ICH GCP guidelines
ICH GCP guidelinesICH GCP guidelines
ICH GCP guidelines
 
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
 
Ndct rule 2019 (manisha)
Ndct rule 2019 (manisha)Ndct rule 2019 (manisha)
Ndct rule 2019 (manisha)
 
Clinical drug development
Clinical drug developmentClinical drug development
Clinical drug development
 

Viewers also liked (10)

Schedule Y
Schedule YSchedule Y
Schedule Y
 
Schedule y
Schedule ySchedule y
Schedule y
 
Schedule y -_priti_gupta
Schedule y -_priti_guptaSchedule y -_priti_gupta
Schedule y -_priti_gupta
 
Emea
EmeaEmea
Emea
 
Code of federal regulations {cfr}
Code of federal regulations {cfr}Code of federal regulations {cfr}
Code of federal regulations {cfr}
 
Cdsco- a regulatory overview
Cdsco- a regulatory overviewCdsco- a regulatory overview
Cdsco- a regulatory overview
 
CDSCO and ADR reporting in India
CDSCO and ADR reporting in IndiaCDSCO and ADR reporting in India
CDSCO and ADR reporting in India
 
Schedule y, mk sharma
Schedule y, mk sharmaSchedule y, mk sharma
Schedule y, mk sharma
 
21 CFR PART 11
21 CFR PART 1121 CFR PART 11
21 CFR PART 11
 
Pharmacovigilance full information
Pharmacovigilance full informationPharmacovigilance full information
Pharmacovigilance full information
 

Similar to Summary Of Schedule Y

Worldwide comprehensive study of guideline on clinical trial
Worldwide comprehensive study of guideline on clinical trialWorldwide comprehensive study of guideline on clinical trial
Worldwide comprehensive study of guideline on clinical trial
RGPV BHOPAL
 

Similar to Summary Of Schedule Y (20)

Schedule Y Summary
Schedule Y SummarySchedule Y Summary
Schedule Y Summary
 
Schedule y draft 2
Schedule y draft 2Schedule y draft 2
Schedule y draft 2
 
Seminar schedule 'y'
Seminar schedule   'y'Seminar schedule   'y'
Seminar schedule 'y'
 
Schedule y jjjjjjjjjjjjjjjjjjjppt
Schedule y jjjjjjjjjjjjjjjjjjjpptSchedule y jjjjjjjjjjjjjjjjjjjppt
Schedule y jjjjjjjjjjjjjjjjjjjppt
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Schedule Y-2019
Schedule Y-2019Schedule Y-2019
Schedule Y-2019
 
Dr.s.s amended schedule y
Dr.s.s   amended schedule yDr.s.s   amended schedule y
Dr.s.s amended schedule y
 
INDA/NDA/ANDA
INDA/NDA/ANDAINDA/NDA/ANDA
INDA/NDA/ANDA
 
PART 1 _ Documentation of drug trials and regulatory filings (1).pptx
PART 1 _ Documentation of drug trials and regulatory filings (1).pptxPART 1 _ Documentation of drug trials and regulatory filings (1).pptx
PART 1 _ Documentation of drug trials and regulatory filings (1).pptx
 
schedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsschedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic acts
 
INDA- Investigation New Drug Application
INDA- Investigation New Drug ApplicationINDA- Investigation New Drug Application
INDA- Investigation New Drug Application
 
Schedule y under drugs and cosmetic act 1945
Schedule y  under drugs and cosmetic act 1945Schedule y  under drugs and cosmetic act 1945
Schedule y under drugs and cosmetic act 1945
 
schedule y
schedule yschedule y
schedule y
 
Post marketing surveillance
Post marketing surveillancePost marketing surveillance
Post marketing surveillance
 
Schedule y
Schedule ySchedule y
Schedule y
 
Worldwide comprehensive study of guideline on clinical trial
Worldwide comprehensive study of guideline on clinical trialWorldwide comprehensive study of guideline on clinical trial
Worldwide comprehensive study of guideline on clinical trial
 
Dcgi adverse event
Dcgi adverse eventDcgi adverse event
Dcgi adverse event
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
 
Indstudies
Indstudies Indstudies
Indstudies
 
Investigational new drug (IND)
Investigational new drug (IND)Investigational new drug (IND)
Investigational new drug (IND)
 

Summary Of Schedule Y