Development safety update report (dsur) pharmacovigilance and safety

According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are 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.
A DSUR should be prepared after the first authorization 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 authorized 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.
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 products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.

1. DEVELOPMENT SAFETY UPDATE REPORT (DSUR)
PHARMACOVIGILANCEANDSAFETY

2. 1.Whatisa DSUR?
2.Dates of implementation
3.Definitions
4.Whena DSUR shouldbe prepared
5.Objectiveof DSUR
6.CommonsectionsDSUR/PBRER/RMP
7.Structureof DSUR
Index

3. Whatisa DSUR?
DevelopmentSafetyUpdateReportsarenew,internationally-harmonized,
safetydocumentscoveringthesafetysummaryofmedicinalproductsduring
theirdevelopmentorclinicaltrialphase.
TheyarebasedheavilyonthePSURformatalreadyusedforupdatingthe
safetyrecordofdrugsintheirmarketingphase.

4. Dates of implementation

5. DefinitionsI
•Adverseevent:
Anyuntowardmedicaloccurrenceinapatientorclinicaltrialsubject
administeredamedicinalproductandwhichdoesnotnecessarilyhavea
causalrelationshipwiththistreatment.Sincethepatientsignsthe
informedconsent.
•Seriousadversereaction:
Anadversereactionwhichresultsindeath,islife-threatening,requiresin-
patienthospitalisationorprolongationofexistinghospitalisation,results
inpersistentorsignificantdisabilityorincapacity,orisacongenital
anomaly/birthdefect.

6. DefinitionsII
•Unexpectedadversereaction:
Anadversereaction,thenature,severityoroutcomeofwhichisnot
consistentwiththesummaryofproductcharacteristics.

7. DefinitionsIII
•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.

8. DefinitionsII
•Post-authorizationsafetystudy:
Apost-authorisationsafetystudy(PASS)isastudythatiscarriedoutafter
amedicinehasbeenauthorisedtoobtainfurtherinformationona
medicine'ssafety,ortomeasuretheeffectivenessofrisk-management
measures
•Post-MarketingSurveillanceStudies(PMS):
Inpost-marketingsurveillancestudies,themedicinalproductwitha
marketapprovalisprescribedintheusualmannerinaccordancewithits
approvedlabeling.Thepatientisassignedtoatherapeuticstrategywithin
currentpractice,notaccordingtoaprotocol,andtheprescriptionis
clearlyseparatedfromthedecisiontoincludethepatientinthestudy.
Diagnosticormonitoringproceduresareonlythoseordinarilyappliedto
thetherapeuticstrategy.

9. Whena DSUR shouldbe prepared
DSUR(DevelopmentSafetyUpdateReport)
ADSURshouldbepreparedafterthefirstauthorisationofaclinicaltrial
worldwide.AcopyoftheDSURshouldbesubmittedtoeachconcerned
EuropeanMemberState(MS)ifaclinicaltrialisauthorisedinthisMSforthis
investigationaldrug(stillusingtheDIBD).Therefore,thefirstDSURcanbe
submittedtoaconcernedMSearlierthan1year,butthecoveredreporting
periodshouldnotbelongerthan1year.
(replacingINDAnnualReportandAnnualSafetyReport)

10. Whena DSUR shouldbe prepared
ThedatesofaDSURandPSURsubmissioncanbe
synchronisedbypreparingaDSURbasedonthe
PSURinternationalbirthday(IBD).Thenthedata
lockpointoftheDSUR,theDIBD,isalignedtothe
oneofPSUR,theIBD.
However,thefirstDSURperiodshouldnotbe
longerthan1year.TheDSURisalwayssubmitted
onayearlybasis.Itisnotallowedtochangethe
IBD.

11. Objectiveof DSUR I
TheDSURpresentsanannualreview&evaluationofsafetyinformation:
•Informationreportedduringthecurrentreviewperiodandanalysisbased
onpreviousknowledgeoftheproduct´ssafety
•Descriptionofnewissuesthatmayimpacttheoverallprogramorspecific
clinicaltrials.

12. Objectiveof DSUR II
I.Summarization of current understanding and management of known and
potential 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. Structureof 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. Structureof DSUR
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 Tabulations
7.1.Reference Information
7.2. Line Listings of Serious Adverse Reactions during the Reporting Period
7.3. Cumulative Summary Tabulations of Serious Adverse Events

15. Structureof DSUR
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

16. Structureof DSUR
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

17. Structureof DSUR
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

18. Structureof 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

19. CommonsectionsDSUR/PBRER/RMP

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