vigilance at excelya
TRANSCRIPT
VIGILANCE AT EXCELYA
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WHO WE ARE
EXCELYA HISTORYSignificant European Experience
ZeinCRO
1998
ITEC Services1984
The Clinical Company2002
Koehler-eClinical1983
Excelya2014
EXCELYA BUSINESS LINES
Full Service
Functional Service
ProviderConsulting
Full CRO capabilitiesAll study phases (I to IV)
All therapeutic areas
All functional capabilities across tailor-made programs
Strategic Resourcing Consultants for all clinical and non-clinical
operation activities
800 permanent staff
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46 employees
66 employees
OUR EXPERTS
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EXCELLING IN VIGILANCE
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VIGILANCE SERVICES
Veterinary Pharmacovigilance
Pharmacovigilance Medical device vigilance
Cosmetovigilance
the Excelya Way
Pharmacovigilance
Veterinary
Medical device
Cosmetovigilance
Quality management
Auditing
Training services• Own-developed and mature SOPs• In-house safety database• Experienced project management
EmployeesYears Experience Countries in ownnetwork
Countries in whichproject presence
>18 65 20 50>>>
VIGILANCE SERVICES
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Internal Quality Standards confirmed with exceptional results from internal, external audits and inspections
HIGH QUALITY STANDARDS
100%with no criticalfindings
100%with no majorfindings
100%with no criticalfindings
77%with 0findings
4%with majorfindings
In the results from Inspections (2018-2019)
In the results from audits (2018-2019)
Post-approval PV system outsourcing• ICSR – assessment, triage, MedDRA coding, processing and reporting• Safety evaluation and medical review• Aggregate reports (PSUR/ PBRER/ PADERs)• Pharmacovigilance System Master File (PSMF) • Risk Management Plans• Safety signal detection• Safety Data Exchange Agreements (SDEAs) set up and maintenance • Setting up and maintenance of EudraVigilance accounts • Registering and maintenance of product information in XEVMPD• Direct Healthcare Professional Communication (DHPC) management
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PHARMACOVIGILANCE (PV) SERVICES
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Post-approval PV system outsourcing§ QPPV/Deputy QPPV provision and assistance• EU Qualified Person for Pharmacovigilance (QPPV), Deputy
QPPV• Guaranteed continuity of the service• 24/7 availability• Access to Safety Physician
§ Local contact/responsible/qualified person for PV• Local contact/qualified person services network in Europe
(including Turkey)
§ Global/Local Literature Review
PHARMACOVIGILANCE (PV) SERVICES
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Post-approval PV system outsourcing§ PV training• Training of PV and non-PV personnel• Tailored training and design for all skill levels/responsibilities in
vigilance procedures using variety of approaches and media
§ Other services• Medical Information handling and provision• Product Technical complaints processing• Consulting• Regulatory support
PHARMACOVIGILANCE (PV) SERVICES
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Clinical Trial PV system outsourcing• Safety review/preparation of safety parts of clinical trial
documents (including Protocol, SAP, CSR)• Preparation of Safety Monitoring/Management Plans
for clinical trial conduct• Individual case safety report (ICSR) processing
for Serious Adverse Events (SAEs)• SUSAR reporting• Aggregate reporting (e.g. DSUR)
PHARMACOVIGILANCE (PV) SERVICES
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• Investigation and assessment of Incidents and near-Incidents
• Screening of literature for identification of events with medical devices
• Reporting Incidents with Manufacturer’s Incident Report
• Preparation and submission of Periodic Summary/Trend Reports
• Implementation and reporting of Field Safety Corrective Action
• Preparation, translation, distribution to receivers and submission to Health Authorities of Field Safety Notices
MEDICAL DEVICE VIGILANCE
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• Provision of Qualified Person Responsible for Pharmacovigilance (24 hour cover)
• Adverse event processing and reporting and efficient handling of communication of safety alerts (off-label, lack of efficacy, potential environmental problems)
• Preparation/Writing/Submission of PSURs• Safety signal detection and Management• Creation and Maintenance of the Detailed Description
of the Pharmacovigilance System (DDPS)
VETERINARY PV SERVICES
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• Screening of literature (both Global and Local) for identification of adverse events
• Safety Data Exchange Agreements (SDEAs) set up and maintenance
• EudraVigilance set-up, maintenance and registration• EudraVigilance Veterinary Medicinal Product Dictionary
(EVVetMPD) maintenance • Company specific SOP Creation & Review• Training of PV and non-PV personnel
VETERINARY PV SERVICES
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• Use of Excelya’s complete set of SOPs or preparation/review of new SOPs for a complete company-specific vigilance system
• Audit of pharmacovigilance systems• 2 experienced auditors• Audits currently performed in GR, CY, BG
• Authority inspection preparation and assistance
• Webinars• Tailor made trainings• PV refreshers
QUALITY MANAGEMENT, AUDITING, TRAINING
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• PV and Safety Department started in 2003 • Successful history of servicing big/mid/small-size pharma
as well as partner CROs within strategic partnerships• 40+ permanent full time employees, including Safety
Officers, Senior Safety Officers, Principal Safety Officers and Safety Managers Experienced project management • Local PV services covering 30 European countries and 16
countries in the MENA region including Turkey
DEPARTMENT OVERVIEW
• 4 European Safety Hubs – Athens (GR), Paris (FR), Sofia (BG), Istanbul (TR) covering project management in EU and non-EU, including MENA region
• Own-developed and mature SOPs and processes• In house safety database (SafetyEasy PV of AB Cube, EVE reports)
• Experienced project management• Flexibility to cover projects growing from 2-3 Safety Officers to
more than 20 Safety Officers per project with consistent efficiency and quality
MAKING A DIFFERENCE BY DESIGN
• Fully validated
• Fully E2B (R3) compliant• Smart MedDRA coding (automatic
recoding with new MedDRA versions)• Integrated Workflow (fully
customizable workflow)• Compliant with ICH, EU GMP Annex 11,
US FDA 21 CFR part 11, EU GVPs
MAKING A DIFFERENCE WITH DATABASE
Physical presence with own network in:BG, CY, CZ, DE, EE,FR, GR, HR, HU, LT,LV, MK, NL, PL, PT,RO, RU, SI, SK, TR,UA
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Countries in whichproject presence
> 50
Countries in ownnetwork
20>
COUNTRIES
• Average 5.4 years of hands-on experience on safety projects
• High English language proficiency• Relevant education with Degrees in
Medicine, Pharmacy and Life Sciences
• Continuous PV training• Comprehensive Performance
Management process with a yearly Performance Appraisal for each employee in place
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STAFF
Up to 1 year
1-3 years
3-5 years
5-10 years
10-15 years
15+ years
PV & Safety – Staff Experience(Snapshot: Jan 2021) – Average: 5,4 years
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18
9
18
4
5
QC Review to minimize individual errorsAdditional quality control by project leaders
Review03
Years of experience and seniority are leveraged to avoid common pitfalls.
Experienced staff01
Comprehensive SOPs, a library of templates/checklists
SOPs, Library & Tools02
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PROCESSES & QUALITY CONTROL
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Clinical Operations 03
Medical Writing
01
Quality Affairs 02
Regulatory Affairs
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DEPARTMENT COLLABORATION
50countries
83clients
150projects
2020
KEY FIGURES
01 Basics
Excelya
SOPs
systems
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02 Client Specific
Client OR Excelya
Client templates
Client SOPs
Client systems
03 Best Practices
Excelya
Communications platform
Lessons learned
QA
Tips and tricks
04 Governance
Client and Excelya
Communications platform
TEAM RAMP UP
Year Inspector Inspected site Audit Outcome Comments
2015 Turkish MoH ZeinCRO Turkey office for PV Minor findings Granted license for PV
2017 Cypriot MoH Client PV system Minor findings Closed
2018 Bulgarian MoH Client PV system No findings Closed
2018 Turkish MoH ZeinCRO Turkey office for PV Minor findings Granted license for PV
2018 Bulgarian MoH Client PV system Minor findings Closed
2019 Cypriot MoH Client PV system Minor findings Closed
2019 Hungarian MoH Client PV system Minor findings Closed
PV SPECIFIC INSPECTIONS
Year Type of audit Number of audits Comments
2013 PV system audit 3 No critical findings
2014 PV system audit 2 No critical findings
2015 PV system audit 2 No critical findings
2016 PV system audit 5 No critical findings
2017 PV system audit 9 No critical findings
2018 PV system audit 13 No critical findings, 2 major total, 8 with 0 findings
2019 PV system audit 15 No critical or major findings, 12 with 0 findings
PV CLIENT AUDITS
2020 PV system audit 9 No critical or major findings, 3 with 0 findings
CRO | 20%
MAH Sponsor | 80 %
Including 6 of the top 10 global pharma
companies
CLIENTS BY TYPE
New | 23%
Repeat | 77%
CLIENTS BY SENIORITY
Other | 3%
Post-Marketing Vigilance | 76%
PROJECTS
Clinical Safety | 21%
“Communication is really good - always very responsive
and flexible to meet with project team members.”
“Excellent collaboration and quick support […] the
team is very friendly, on time and always helpful.”
“High level of professionalism and
continuity of the services.”
“The staff […] has professional experience and deep knowledge
of their project! They are always very friendly and work to quickly
resolve any issues.”
“There is nothing that needs to be improved!”
SATISFYING CLIENTS’ NEEDS
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THANK YOU!