Pharmacovigilance services by PharmExpert

1
PharmExpert LLCPresentation of Service
Provider2024 (v.03)
2
History Company profile

• The company was founded on Feb 2019 by a team of
  specialists with in-depth knowledge and practical
  experience in various pharmaceutical fields such
  as manufacturing, clinical trials, regulatory
  affairs, as well as medicine, and business.
• PharmExpert LLC is primarily engaged in providing
  a complete range of drug safety services to
  Marketing Authorization Holders and
  Pharmacovigilance Service Providers.
• PharmExpert recognizes the critical importance of
  Good Pharmacovigilance Practices (GVP) for
  patient safety. The Company views this aspect as
  a primary responsibility in its pharmacovigilance
  operations, and has adopted appropriate quality
  standards to ensure public health and customer
  satisfaction.
• PharmExpert has established, maintains and
  applies a Quality Management System in compliance
  with the international standard ISO 90012015 and
  Good Pharmacovigilance Practices guidelines.
• PharmExpert commits to provide clients with a
  service and delivery that consistently meets
  international and local legislations.
• The company has achieved customer loyalty by
  practicing a policy of strong communication and
  working closely with customers to deliver to
  their exact specifications.

3
Company Objectives

• The key aim at all times is to ensure prompt and
  effective functioning of all the Companys
  processes and activities.
• In line with this strategic vision, our
  main objectives are
• To provide adequate, reliable and regulatory
  compliance services
• Optimize the performance of Companys business
  and pharmacovigilance processes by maintaining
  continuous improvement of Quality Management
  System
• Effectively address and satisfy any existing and
  projected needs of educational, training and
  professional development needs of employees and
  other stakeholders of the Company
• Build client loyalty by meeting or exceeding our
  customer expectations and contractual
  obligations.

4
QS, PV Procedures and Processes

• Quality Assurance (13 SOPs)
• SOP-QA-001 Good Documentation Practices
• SOP-QA-002 SOP on SOP
• SOP-QA-003 Pharmacovigilance Glossary
• SOP-QA-004 Non-Conformity Management
• SOP-QA-005 Change management
• SOP-QA-006 PSMF Management
• SOP-QA-007 Business Continuity and Disaster
  Recovery
• SOP-QA-008 Internal and External Audits
• SOP-QA-009 Inspection of PV System
• SOP-QA-010 Translation of Documents
• SOP-QA-011 Quality Risk Management
• SOP-QA-012 Management Review
• SOP-QA-013 Personal Data Protection

• Determined processes by the company in scope of
  offered services grouped in 4 sections
• Quality Assurance (QA)
• Pharmacovigilance (PV)
• Human Resources (HR)
• Information Technology (IT)

5
QS, PV Procedures and Processes

• Human Resources with (4 SOPs)
• SOP-HR-001 Human Resources Management
• SOP-HR-002 Training
• SOP-HR-003 QPPV Role and Responsibilities
• SOP-HR-004 Substitution of QPPV_LCPPV
• Information Technology (2 SOPs)
• SOP-IT-001 Information Security
• SOP-IT-002 Computerized System Validation

• Pharmacovigilance (18 SOPs)
• SOP-PV-001 Adverse Event Processing
• SOP-PV-002 Adverse Processing in Clinical
  Trials
• SOP-PV-003 Case Assessment
• SOP-PV-004 Local Pharmacovigilance Activity
• SOP-PV-005 Product Quality Complaints
• SOP-PV-006 Literature Monitoring
• SOP-PV-007 Regulatory Intelligence Monitoring
• SOP-PV-008 Signal Management
• SOP-PV-009 Product Recalls and Restrictions
• SOP-PV-010 Safety Changes to the SmPC_PL
• SOP-PV-011 PSUR Management
• SOP-PV-012 Safety Communication to
  HCPs_non-HCPs
• SOP-PV-013 Risk Management Plan
• SOP-PV-014 DSUR Management
• SOP-PV-015 Service agreements
• SOP-PV-016 Urgent Safety Restrictions
• SOP-PV-017 Handling of RA Requests
• SOP-PV-018 Medical Information Enquiries

6
Countries of activity

• Azerbaijan
• Belarus
• Georgia
• Kazakhstan
• Kyrgyzstan
• Russia
• Tajikistan
• Turkmenistan
• Ukraine
• Uzbekistan

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Scope of PV Services

• Development and maintenance of Pharmacovigilance
  System Master File (PSMF)
• Appointment of QPPV (Qualified Person responsible
  for PV) and QPPV back-up
• Weekly monitoring of scientific-medical
  literature, non-medical sources, internet or
  digital media for safety information search at a
  local and global levels
• Weekly regulatory intelligence monitoring of
  Health and Regulatory Authorities for safety
  information and regulatory updates at a local and
  global levels
• Collection, processing, evaluation, regulatory
  reporting, storage and archiving of Adverse
  Events (AE) and other safety related information
  from any sources
• Development of aggregate reports Periodic Safety
  Update Reports (PSUR)/ Periodic Benefit-risk
  Evaluation Report (PBRER), Development Safety
  Update Report (DSUR)
• Development of Risk Management Plan (RMP)
• Assessment of the benefit-risk ratio of the MP

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Scope of PV Services

• Development and conduction of PV trainings
• Conduction of external audits
• Appointment of LPPV (Local Person for
  Pharmacovigilance) and LPPV back-up in the MPs
  authorization countries
• Safety database maintenance
• Signal detection and management
• Safety communication
• Managing medical information requests obtained
  from Consumers/HCPs/Sales representatives
• Conducting post-authorization safety studies
  (PASS)
• Interaction with regulatory authorities on drug
  safety issues
• Consulting services on issues in the field of PV
• Obtaining, processing and reporting information
  on safety in PASS
• Outsourcing of entire Pharmacovigilance System.

9
Actual PV Service Agreements

• Total of INNs in portfolio 800
• Service agreements with MAHs - 30
• Service agreements with PV Service Providers - 10
• Total of supported MAHs 68
• MAH countries Belarus, China, Egypt, France,
  Germany, India, Italy, Latvia, Poland, Russia,
  Saudi Arabia, Slovenia, Switzerland, Turkey,
  Ukraine, USA
• Worldwide top ten ranked MAHs - 2
• Worldwide 1 ranked service provider in Health
  Care (Pharmacy and Other Services) - 1

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What are our Advantages?

• Cloud based shared storage with ensured CIA
  principle Confidentiality, Integrity,
  Availability
• Reminder and Checklist based completion of
  routine tasks
• Quality compliance monitoring on a weekly,
  quarterly, semiannually, annually basis via 20
  KPIs
• Daily based automatic monitoring of authority
  webpages
• Advanced and precise search system, multilanguage
  key words usage, quality control and documenting
  of search results

• Cost effective service fee
• Automatic tracking of PSUR submission timelines
• Online training platform
• Successfully passed 7 audits
• Validated computerized systems
• Positive customers feedback
• Continuous improvement
• Etc.

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End

• Thank you!
• PharmExpert LLC
• Address Tabriz str.122.Baku, Azerbaijan AZ1075.
  Business center Azaro Plaza.
• Email info_at_pharmex.co. Tel [phone]