DSUR complete topic

1. Name – Sumit
Roll no. 2250981548

2. Index
*1. What is a DSUR?
*2. Dates of implementation
*3. Definitions
*4. When a DSUR should be prepared
*5. Objective of DSUR
*6. Structure of DSUR

3. What is a DSUR?
*Development Safety Update Reports are new,
internationally-harmonized, safety documents covering
the safety summary of medicinal products during their
development or clinical trial phase.
*They are based heavily on the PSUR format already used
for updating the safety record of drugs in their
marketing phase.

4. Dates of implementation
*ICH guideline E2F on development safety update report
Transmission to CHMP June 2008
Adoption by CHMP for release for
consultation
June 2008
End of consultation (deadline for
comments)
December 2008
Final adoption by CHMP September 2010
Date for coming into effect September 2011

5. Definitions I
*Adverse event:
Any untoward medical occurrence in a patient or clinical trial subject
administered a medicinal product and which does not necessarily have
a causal relationship with this treatment. Since the patient signs the
informed consent.
*Serious adverse reaction:
An adverse reaction which results in death, is life-threatening,
requires in- patient hospitalisation or prolongation of existing
hospitalisation, results in persistent or significant disability or
incapacity, or is a congenital anomaly/birth defect.

6. Definitions Il
*Unexpected adverse reaction:
An adverse reaction, the nature, severity or outcome of
which is not consistent with the summary of product
characteristics.

7. Definitions II
*Post-authorization safety study: A post-authorisation safety study
(PASS) is a study that is carried out after a medicine has been
authorised to obtain further information on a medicine's safety, or
to measure the effectiveness of risk-management measures.
*Post-Marketing Surveillance Studies (PMS):In post-marketing
surveillance studies, the medicinal product with a market approval
is prescribed in the usual manner in accordance with its approved
labeling. The patient is assigned to a therapeutic strategy within
current practice, not according to a protocol, and the prescription is
clearly separated from the decision to include the patient in the
study. Diagnostic or monitoring procedures are only those
ordinarily applied to the therapeutic strategy.

8. Definitions III
*Non-Interventional Studies (NIS):Non-interventional
trials include post-marketing surveillance studies (PMS),
post authorization safety studies (PASS), cohort studies,
case- control studies, and register studies.
*Whereas in phase 1-4 clinical trials the efficacy of an
investigational product is explored in a patient population
which has been selected according to strong inclusion
and exclusion criteria, in non-interventional trials patients
are treated under real life conditions to investigate the
effectiveness of a drug.

9. When a DSUR should be prepared
*DSUR (Development Safety Update Report) A DSUR
should be prepared after the first authorisation of a clinical
trial worldwide. A copy of the DSUR should be submitted
to each concerned European Member State (MS) if a
clinical trial is authorised in this MS for this
investigational drug (still using the DIBD). Therefore, the
first DSUR can be submitted to a concerned MS earlier
than 1 year, but the covered reporting period should not be
longer than 1 year.
(replacing IND Annual Report and Annual Safety Report)

10. *The dates of a DSUR and PSUR submission can be
synchronised by preparing a DSUR based on the PSUR
international birthday (IBD).
* Then the data lock point of the DSUR, the DIBD, is
aligned to the one of PSUR, the IBD.However, the first
DSUR period should not be longer than 1 year. The
DSUR is always submitted on a yearly basis. It is not
allowed to change the IBD.

11. Objective of DSUR I
*The DSUR presents an annual review & evaluation of
safety information:
Information reported during the current review period and
analysis based on previous knowledge of the product's
safety
Description of new issues that may impact the overall
program or specificclinical trials.

12. Objective of DSUR II
1.Summarization of current understanding and
management of known andpotential safety risks to exposed
patients.
II. Examine changes in the product's safety profile.
III. Provide an update on the status of the clinical
development program.

13. Structure of DSUR
*Title page.
*Executive Summary.
*Table of Contents.
1. Introduction.
2. Worldwide Marketing Approval Status
3. Actions Taken in the Reporting Period for Safety
Reasons.
4. Changes to Reference Safety Information.
5. Inventory of Clinical Trials Ongoing and Completed
during the Reporting Period.

14. 6. Estimated Cumulative Exposure
6.1. Cumulative Subject Exposure in the Development
Programme
6.2. Patient Exposure from Marketing Experience
7. Data in Line Listings and Summary Tabulations7.1.
Reference Information
7.2. Line Listings of Serious Adverse Reactions during the
Reporting Period
7.3. Cumulative Summary Tabulations of
Serious Adverse Events

15. 8. Significant Findings from Clinical Trials during the
Reporting Period
8.1. Completed Clinical Trials
8.2. Ongoing Clinical Trials
8.3. Long-term Follow-up
8.4. Other Therapeutic Use of Investigational Drug
8.5. New Safety Data Related to Combination Therapies
9. Safety Findings from Non-interventional Studies
10. Other Clinical Trial/Study Safety Information
11. Safety Findings from Marketing Experience
12. Non-clinical Data
13. Literature
14. Other DSURS

16. 15. Lack of Efficacy
16. Region-Specific Information
17. Late-Breaking Information
18. Overall Safety Assessment
18.1.Evaluation of the Risks
18.2.Benefit-risk Considerations
19. Summary of Important Risks
20. Conclusions
Appendices to the DSUR

17. Structure of DSUR
*Estimated Cumulative Exposure
•Cumulative Subject Exposure in the Development
Programme
•Patient Exposure from Marketing Experience
Data in Line Listings and Summary Tabulations
•Reference Information
•Line Listings of Serious Adverse Reactions during the
Reporting Period
•Cumulative Summary Tabulations of
Serious Adverse Events