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Drug Safety Pharmacovigilance

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Validation of e.g. ARGUS 3. Database Maintenance. Literature database set ... Providing hands-on training for ARGUS. Concepts and pharmacovigilance procedures ... – PowerPoint PPT presentation

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Title: Drug Safety Pharmacovigilance


1
Pharmacovigilance by Dr. Notghi Contract
Research
2
Our Medical Drug Safety Services
  • Call Centre
  • Drug Safety Data Entry
  • Literature Surveillance
  • Analysis and Reporting
  • Medical writing
  • IT Services

3
AE/SAE Data Collection Processing
Dr. Notghi CRO Drug Safety Unit
Safety DB
AEs/SAEs entered to DB
Literature
Call Centre
4
Call Centre Services
Data Collection
Registration Data Entry
SAE transfer data to Safety Database System
5
Web Portal
  • Secure web-based portal for data collection
  • Product Complaints
  • Medical/Technical Inquires
  • Adverse Events

6
Product and Clinical Trial Safety Monitoring
  • AE/SAE Reports (per fax, email, mail)
  • Data Entry by trial specific trained personnel
  • Quality Check
  • Monitor/Investigator contact
  • Analysis and Reporting

7
Literature Surveillance Process
  • Product specific literature database search
  • Librarian services
  • Data Entry
  • Quality Check
  • Analysis and Reporting

8
Safety Data Retrieval / Data Mining
Dr. Notghi CRO Drug Safety Unit
Safety Data Retrieval and Data Mining
Analysis and Reporting
Client
9
IT Services for Medical Drug Safety
  • Validation of e.g. ARGUS 3
  • Database Maintenance
  • Literature database set-up
  • Programming, etc.

10
Quality Assurance
  • Compliance with regulatory requirements
  • Client internal quality assessments
  • Training
  • QC Checks
  • Ensuring consistency and validity, coding
    accuracy, clinical assessment

11
Client Specific Compliance
  • Corporate Standard Operating Procedures
  • Client SOPs and Working Procedure
  • Client Specific Templates
  • Client Specific Trial Management Systems and DM
    Systems

12
Training
  • Providing hands-on training for ARGUS
  • Concepts and pharmacovigilance procedures
  • MedDRA and GCP/ICH training

13
Contact
Dr. Notghi Contract Research Zimmerstrasse 55 D-
10117 Berlin-Mitte Germany Tel. 49-30-46064
780 Fax 49-30-46064 733 Email
contact_at_notghi.com Homepage www.notghi.com
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