VIGILANCE AT EXCELYA

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!