Pharmacovigilance

Drug Safety

Pharmacovigilance is the continuous and systematic monitoring of drug safety. This means diligently monitoring any harmful or adverse effects in order to evaluate and understand the root of the problem. The data are essential for efficient risk management and implementing appropriate measures to minimize risks.

We understand that the challenges in pharmacovigilance are constantly changing and the requirements are getting more complicated and steadily growing larger. To keep pace and comply with the rapidly changing legal and scientific requirements, it is essential to find a competent and flexible partner, with years of experience in the field of pharmacovigilance. We at DREHM Pharma have the capacity to meet your needs by leading the way with consulting services as well as covering the requirements of your company for outsourcing your pharmacovigilance activities.

How does DREHM Pharma support you with Pharmacovigilance?

Complete outsourcing

DREHM Pharma has an established pharmacovigilance team, which has been inspected and approved by the Austrian authorities. We offer services as a complete package (including a Qualified Person for Pharmacovigilance – QPPV) or à la carte according to your requirements.

Processing of side effects

Our Pharmacovigilance Team guarantees speedy admissions, assessments, evaluations, database entry, medical assessments of Individual Case Safety Reports (ICSR), quality checks using the 4-eyes principle, reporting to the authorities and follow-up procedures.

Database

DREHM Pharma hosts a valid compliant E2B adverse reaction database (PcVmanager of EXTEDO) and establishes for each customer a separate secured area with private access. Evaluations, such as line listing, summary tabulation, CIOMS reports and frequency analysis for signal detection, are accurately run.

Our Pharmacovigilance Team (with QPPV) has a guaranteed 24-hour emergency number.

Team Pharmacovigilanz - Meet the TeamTeam Pharmacovigilance Meet the Team!

Pharmacovigilance System Master Files (PSMF)

DREHM Pharma creates customized PSMFs according to demand.

Periodic Safety Update Report (PSUR)

We prepare PSURs with Clinical Expert Statements on request.

Risk Management Plans (RMP)

We support you with the creation of RMP.

EudraVigilance (EV)

  • Registration: DREHM Pharma can register companies to the European pharmacovigilance authority and / or serve as a Third Party Service Provider (ICSR- and XEVMPD certificate provided by DREHM Pharma).
  • Individual Case Safety Report (ICSR): We provide GVP compliant reporting to the applicable authorities.
  • eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Since July 2012, all EU-approved drugs must be registered in the new EV-database. Each entry must also be properly maintained, including all variations and additional information.
  • Medical Dictionary for Regulatory Activities (MedDRA): MedDRA licenses are required for all authorization holders within the European Union. Fee waivers are available for Small and Medium Sized Enterprises (SME). DREHM Pharma performs both SME and MedDRA registrations.

Literature search

DREHM Pharma provides comprehensive support with thorough reviews of literature in both international and national publications.

Pharmacovigilance audits

DREHM Pharma provides audits of pharmacovigilance systems in the context of self-inspections or as a pre-inspection audit.

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