The document details a pharmacovigilance workshop focused on exploring publicly available data sources related to drug safety. It discusses significant safety withdrawals of medicines due to adverse effects not detected in clinical trials, as well as various information sources such as clinical trial registries and databases for drug safety surveillance in the USA and Europe. Additionally, it provides links to important resources for product authorization and labeling, aiming to enhance understanding of drug safety mechanisms.

1. PHARMACOVIGILANCE
WORKSHOP
Veronika Valdova
ARETE-ZOE, LLC
9/7/2022
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE
DATA SOURCES IN DRUG SAFETY
1

2. Agenda
Safety withdrawals
PV System Overview
• USA, EU
Publicly available sources
• PV Databases
• Clinical Trial Registries
• Product Authorization
• Product Labeling
9/7/2022
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES
IN DRUG SAFETY 2

3. Significant Safety Withdrawals
​Medicines may be withdrawn from markets because
of risks to patients or for business reasons. Change
of benefit:risk profile to unfavorable is usually
prompted by adverse effects that were either not
previously detected, are more frequent or more
severe than anticipated based on Phase III clinical
trials. Market withdrawals are triggered by adverse
events that were only made apparent
from postmarketing surveillance data collected from
population-wide use over longer periods of time.
9/7/2022 P V W O R K S H O P : E X P L O R E P U B L I C L Y A V A I L A B L E D A T A S O U R C E S I N D R U G S A F E T Y 3

4. Sources of information leading to market withdrawal
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE
DATA SOURCES IN DRUG SAFETY
9/7/2022 4
Craveiro NS, Lopes BS, Tomás L, Almeida SF. Drug Withdrawal Due to Safety: A Review of the Data
Supporting Withdrawal Decision. Curr Drug Saf. 2020;15(1):4-12. doi:
10.2174/1574886314666191004092520. PMID: 31584381.

5. Cardiovascular drugs withdrawn for safety reasons
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE
DATA SOURCES IN DRUG SAFETY
9/7/2022 5
Kocadal
K,
Saygi
S,
Alkas
FB,
Sardas
S.
Drug-
associated
cardiovascular
risks:
A
retrospective
evaluation
of
withdrawn
drugs.
North
Clin
Istanb
2019;6(2):196–202.

6. Pharmacovigilance Databases
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE
DATA SOURCES IN DRUG SAFETY
9/7/2022 6
EudraVigilance
FAERS

7. DRUG SAFETY
SURVEILLANCE
IN EUROPE
Adverse Drug Events in
• Clinical Trials
• Post-Market Use
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY

8. EudraVigilance System Components
9/7/2022
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA
SOURCES IN DRUG SAFETY 8

9. HTTP://WWW.ADR
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE
DATA SOURCES IN DRUG SAFETY 9/7/2022 9
HTTP://WWW.ADRREPORTS.EU/
EudraVigilance
European database of suspected
adverse drug reaction reports

10. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 10
HTTP://WWW.ADRREPORTS.EU/

11. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 11
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P
:/
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RTS.
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12. DRUG SAFETY
SURVEILLANCE
IN THE USA
Adverse Drug Events in
• Clinical Trials
• Post-Market Use
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY

13. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 13
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformatio
n/Surveillance/AdverseDrugEffects/ucm070093.htm

14. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 14
MedWatch Alerts

15. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 15
https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-
6d3021737452/state/analysis

16. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 16
https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-
6d3021737452/state/analysis

17. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 17
https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-
6d3021737452/state/analysis

18. CLINICAL TRIAL
REGISTRIES
• ClinicalTrials.gov
• EU CT REGISTER
• WHO ICTRP
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY

19. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 19
https://clinicaltrials.gov/

20. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 20
https://clinicaltrials.gov/
Clinical trails with bevacizumab

21. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 21
https://www.clinicaltrialsregister.eu/

22. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 22
https://www.clinicaltrialsregister.eu/

23. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 23
https://trialsearch.who.int/Default.aspx

24. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 24
https://trialsearch.who.int/Default.aspx

25. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 25
https://trialsearch.who.int/Default.aspx

26. PRODUCT
AUTHORIZATION
• EU ARTICLE 57 DATABASE
• NDC DIRECTORY
• EU NATIONAL REGISTRIES
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY

27. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 27
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/data-
medicines-iso-idmp-standards/public-data-article-57-database

28. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 28
https://www.ema.europa.eu/en/medicines/national-registers-authorised-medicines

29. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 29
https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm

30. PRODUCT
LABELING
• DAILYMED
• UK eMC
• UNION REGISTER OF MPs
• EU NATIONAL REGISTRIES
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY

31. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 31
https://dailymed.nlm.nih.gov/dailymed/

32. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 32
https://www.medicines.org.uk/

33. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 33
https://ec.europa.eu/health/documents/community-register/html/index_en.htm

34. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 34
https://ec.europa.eu/health/documents/community-register/html/index_en.htm

35. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 35
https://ec.europa.eu/health/documents/community-register/html/index_en.htm

36. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 36
https://ec.europa.eu/health/documents/community-register/html/index_en.htm

37. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 37
https://www.ema.europa.eu/en/medicines/national-registers-authorised-medicines

38. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 38
https://www.sukl.eu/modules/medication/search.php?lang=2

39. ADDITIONAL
RESOURCES
• CPIC
• DRUGBANK
• PUBMED
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY

40. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 40
https://cpicpgx.org/genes-drugs/

41. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 41
https://go.drugbank.com/drugs/DB00178

42. PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE DATA SOURCES IN DRUG SAFETY 42
https://www.ncbi.nlm.nih.gov/pubmed

43. THANK YOU
Veronika Valdova
veronikav@arete-zoe.com
https://www.aretezoe.com /
PV WORKSHOP: EXPLORE PUBLICLY AVAILABLE
DATA SOURCES IN DRUG SAFETY
9/7/2022 43