18-3 – IQVAMED

IQVAMED

IN Scope activities for PV

Mailbox management for clinical & spontaneous cases.
Literature Screening.
Legal case processing.
Case intake and Triage.
ICSR Processing/submissions.
Aggregate Reports: PADERs.
PSURs.
Signal detection.
Narrative writing.
Medical Review.
SAEs/SUSARs Management.
SAEs/SUSARs Management..

In Scope of End-to-End Safety Solutions

Pharmacovigilance Operations

Call Center

Case Processing: Collection , Triaging, Data Entry, QC and Processing of ICSRs

Literature Screening

Mailbox Management for Clinical & Spontaneous cases

Narrative Writing

Medical Review

Regulatory Submission

Expedite Reporting

Single Cases of Serious, Unexpected ADRs

Serious Adverse Events/ SUSARs Management

Aggregate Reporting

DSURs, IND ARs

PSURs, PBRERs, PADERs and ASRs

Bridging and Ad-Hoc Reports

Signal Detection and Risk Management

Safety Surveilance and Signal Detection

Risk Management/ Minimization Plans, RMP & REMS

Safety Consulting

🙶 A Survey to Evaluate Healthcare Professionals' Awareness, Knowledge, and Reporting Methods of Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs): An Assessment of Current Practices and Opportunities for Improvement. 🙷

iqvamed Clik here to complete the Assessment

Our quality system is based on all of the following activities:

quality planning

Establishing structures and planning integrated and consistent processes;

quality adherence

Carrying out tasks and responsibilities in accordance with quality requirements;

quality control and assurance

Monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out; and

quality improvements

Correcting and improving the structures and processes where necessary.

Our Expertise and qualified person for pharmacovigilance (QPPV’s) are able to :

gain assurance that a pharmacovigilance system has been implemented in accordance with the requirements;

confirm aspects of compliance in relation to the system;

obtain information about deficiencies in the system, or non-compliance with the requirements;

obtain information about risks or actual failure in the conduct of specific aspects of pharmacovigilance.

Appropriate Measures to Collect and Collate All Reports SADRs :

We take appropriate measures to collect and collate all reports of suspected adverse reactions associated with medicinal products for human use originating from unsolicited or solicited sources. And our system allow the acquisition of sufficient information for the scientific evaluation of those reports.

Our Designed and structured system help to ensure that the collected reports are authentic, legible, accurate, consistent, verifiable and as complete as possible for their clinical assessment, and allows for reports of suspected adverse reactions to be validated in a timely manner and exchanged between competent authorities and IQVAMED within the legal submission time frame.

Safety Data Monitor

IQVAMED monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the risk-benefit balance of medicinal products and update the risk management system and the RMP.

We offer a comprehensive range of risk management services to ensure that our clients’ products are developed, monitored, and marketed safely and effectively.

RMP Development

Our experienced risk management team works closely with clients to develop customized Risk Management Plans (RMPs) that identify potential risks, evaluate risk factors, and create strategies to minimize risks. We follow a rigorous process that includes thorough analysis of safety data and compliance with regulatory requirements.

RMP Quality Management

We have a robust quality management system for risk management that ensures compliance with regulatory guidelines and adherence to best practices. Our team of experts is committed to ensuring that all safety data is collected, analyzed, and reported with the utmost accuracy and integrity.

Review the existing Pharmacovigilance systems and establish its compliance with Regulation:

IQVAMED offers a full range of Pharmacovigilance audit services in accordance with good pharmacovigilance practices (GVP) requirements and global regulations.

In addition to our standard comprehensive system GVP auditing services, IQVAMED offers a flexible and customizable GVP auditing service that can cover one or multiple sectors on a global scale. Our team of experienced pharmacovigilance professionals can tailor our auditing services to meet the specific needs of our clients in the pharmaceutical, biotech, and medical device industries.

At IQVAMED, we are committed to providing our clients with the highest quality of service, and our customized GVP auditing service is designed to meet the unique needs of each client. Our global reach and expertise allow us to provide comprehensive auditing services that meet regulatory requirements and ensure the safety and well-being of patients.