PHARMACOVIGILANCE IN LOCAL CLINICAL

TRIALSJulia TrakhtenbergMedical Director

IPHARMA LLCNovember 26, 2015

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SPONSOR'S RESPONSIBILITIES ON PHARMACOVIGILANCE 1.1. Implementation and maintenance of written SOP system 1.2. Reporting timelines on Suspected Unexpected Serious Adverse Reactions (SUSAR)1.3. Data requirements on SUSAR reporting1.4. Requirements on relevant safety information 1.5. Provision of other safety information

* GCP ЕАES, Appendices 3. Safety reporting in clinical trials

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SPONSOR'S RESPONSIBILITIES ON PHARMACOVIGILANCE 1.6. Safety data reporting form1.7. Scope of safety reporting responsibility1.8. Serious Adverse Reactions not related to study drug1.9. Unblinding1.10. Annual safety reports (DSUR)

* GCP ЕАES, Appendices 3. Safety reporting in clinical trials

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PHARMACOVIGILANCE IN LOCAL CLINICAL TRIALS

Data collection

• Discussion with the site and obtaining of the relevant data (medical history, concomitant medication)

• Detailed narrative

Report preparatio

n

• Causality and expectedness assessment• Expedited report preparation (CIOMS form)• Sponsor's decision/confirmation

Report

• Transferring a CIOMS report to the Regulatory Department and the Project Manager

• Submission of the report to Regulatory Authorities, Investigators and Local Ethics Committees

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• Initial triage of SAE report

• Maintaining of the Safety Database

Medical Assistant

• Safety data review • Causality and

expectedness assessment

Medical Advisor • Data completeness checking and SUSAR/DSUR reports preparation

Qualified Person responsible for PV

SPONSOR

SPONSOR AND CRO MEDICAL DEPARTMENT COOPERATION

INVESTIGATOR

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MEDICAL DEPARTMENT AT CROMedical Writing• Investigator’s Brochure, SmPC, PIL• Drug development program• Study design → Synopsis → Protocol• Coordination with KOLs• Study report writing• Scientific publications• Presentations at conferences

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MEDICAL DEPARTMENT AT CROMedical Monitoring• Trainings (Investigators meeting, therapeutic area training)• Informational support for investigators and CRAs during the

study• Inclusion/exclusion criteria• Adverse Events reporting• Protocol deviations• Discontinuation criteria and early withdrawal• Unblinding

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MEDICAL DEPARTMENT AT CROSafety Monitoring• Lab Alerts• Adverse events registration • Preparation of expedited reports • Data Safety Monitoring Board (DSMB)• Safety Data analysis (AE listings review, SAE reconciliation)• Pharmacovigilance

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MEDICAL DEPARTMENT AT CRO

Medical Director

Qualified Person

responsible for PV

Maintenance of the PV system

Communication with the regulatory authorities

Medical Advisors

Therapeutic expertiseMedical writing (Protocol,

ICF)Medical monitoring

Medical Specialist

Safety data analysisIB writing

Medical Assistant

Reports maintenance, tracking, filing, and data

entry

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MEDICAL DEPARTMENT STAFF ESSENTIAL SKILLS• MD, Ph.D., therapeutic specialization• Medical practice (5-10 years)• Clinical trial experience (co-investigator, CRA)• Good level of English • Literature review skills, experience in medical

writing, publications• Basic knowledge of medical statistics • Presentation skills• Communication skills

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KEY FOR EFFECTIVENESS AND SUCCESS• Qualification and background of the team• Efficient, coordinated, and regularly updated

SOP system based on Local and International requirements

• Safety data collection and maintenance system• Streamline communication with Sponsors, PMs,

team members, and between departments→ important decisions are made TOGETHER

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THANK YOU FOR YOUR ATTENTIONJulia Trakhtenberg, MD, PhDMedical Director7 Nobel streetSkolkovo Innovative CenterMoscow, 143026, RussiaMobile: +7 (926) 098-2107Phone: +7 (495) 276-1143Fax: +7 (495) 276-1147 E-mail: jat@ipharma.ru Web-site: www.ipharma.ru

Safety mailbox: SAE@ipharma.ru