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KMT Pharm, s.r.o. | Slovakia

Professional Pharmacovigilance and QPPV Services

Our Services

Our Services

Pharmacovigilance Systems

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File (PSMF) is required in many countries to be a Marketing Authorization Holder. The PSMF needs to be available for inspections and/or audits at all times. Required components varies across geographic regions.

Standard Operating Procedures (SOP) describe the critical processes within your pharmacovigilance system.

Pharmacovigilance Training

The competence of your pharmacovigilance team members is related to your audit and inspection results. To make sure our clients are prepared, we provide all levels of pharmacovigilance training and courses can be customized to meet specific requests.

• Extensive PV Training for different groups of employees and hierarchical levels in the company (pharmacovigilance, interacting departments, all staff)
• Tailored PV Training on concrete topics (PSMF, QPPV, Risk management and others)
• PV training on PV regulatory requirements on global, regional, and local levels

Monitoring of medical literature

Scope of services:
Ongoing monitoring of local medical and pharmaceutical journals by team of qualified and experienced reviewers
• (HCPs – physicians and pharmacists)
• manual review of full-text articles to identify substances (including local synonyms and common names),
• products, decoding of treatment regimens
• delivery of Safety Reports (mainly for ICSRs) with source document within 24 hours from identification of Safety
• Relevant Information
• weekly reconciliation reports delivered on second business day of following week (latest)
• statistical report of weekly reviewed journals and articles
• detail information presented in Safety Reports and Regular Reports concerning (if available):
• Patient – gender, age, initials, other identifications
• substance – brand, dose/dosage, route of administration, pharmaceutical form
• event/reportable situation – PV categorization and description, timeframe
• author’s attribution of event/situation to drug statement
• country of occurrence (or country of 1st author)
• awareness date (Day 0) and delivery date
• Reporter identification (if differs from the Author)
• full citation of article
• list of exclusion criteria for Safety Report
• short comment in local language and English
• bi-annual journal list update process

Preparation of PSUR, RMP, Readability Test

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.

RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. Companies need to submit an updated RMP:

• at the request of EMA or an NCA;
• whenever the risk-management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached.

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Years of Experience
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Years of Experience

Our Services

EU QPPV and LCP for Slovakia

QPPV - Qualified Person Responsible for Pharmacovigilance

EU QPPV - The EU QPPV is responsible for the PV system within the EU.

Deputy QPPV - If your organization is anticipating a future or current need for the Deputy QPPV role, we can assist you.

Local QPPV and Local PV Persons for Slovakia

The Local Person for Pharmacovigilance in the EU ensures that a company complies with pharmacovigilance requirements when marketing a medicinal product in that Member State. This includes ensuring that a company has systems and processes to collect, record, report and follow up on suspected adverse reactions.

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Are you interested in pharmacovigilance services or are you looking to learn more? Send us a message!