Pharmacovigilance at Eignapharma

Eignapharma will guide you in the process of achieving a healthy and compliant Pharmacovigilance system, whether in a European framework or other International settings. Our experienced team has strong knowledge of International drug safety regulations and a strong commitment to working with high Quality standards. We have a close look at the future direction of Pharmacovigilance by permanently liaising with leading experts and regulators, thus putting ourselves into such a position so we can plan in advance any upcoming change and better protect your interests.

 

Pre-Marketing Authorisation Application

EU QPPV

Appointment of European Qualified Person for Pharmacovigilance.

PSMF

Authoring and maintenance of the Pharmacovigilance System Master File.

RMP

Authoring and maintenance of the Risk Management Plan.

Marketing Authorisation Holder

Local QPPV

Appointment of a local Qualified Person for Pharmacovigilance, when applicable.

XEVMDP maintenance

Maintenance of EMA’s Art. 57 Database via the XEVMPD.

SDEAs and contractual agreements 

Preparation and Review of Safety Data Exchange Agreements (SDEAs) and Contractual agreements with third-parties (e.g. distributors, manufacturers) and/or other MAHs involved in a procedure (e.g. DCPs).

Regulatory & Pharmacovigilance intelligence

Monitoring of Global and Local regulations/guidelines and worldwide product related safety matters.

Signal Management Signal

Management including signal detection and mandatory EVDAS activities as applicable.

PSUR

Authoring of Periodic Update Safety Reports and subsequent submission to the EMA PSUR Repository.

PV training

Mandatory training on Pharmacovigilance to all employees (Induction and Refresh trainings).

Periodic reconciliations

Periodic reconciliation of cases/PQCs/medical enquiries exchanged between Parties.

General Data Protection Regulation (GDPR)

Data declaration to the personal data protection agencies.

Medical enquiries

Handling of medical enquiries.

Social Media monitoring

Screening of social media accounts sponsored by the Client.

Marketing Authorisation Application

Global scientific literature screening

Worldwide weekly literature monitoring.

Local scientific literature screening

Weekly literature monitoring in local databases and/or relevant journals not indexed globally, as applicable in each country.

Quality management system

Authoring and maintenance of Standard Operating Procedures (SOPs).

GVP audits

 

Marketing Authorisation Holder MP

ICSR management & database/tracking tool

Collection and handling of Safety Reports. Medical assessment & Follow-up.

ICSR Reporting to the Health Authorities

ICSR submission to EudraVigilancevia EVWEB.

PQCs

Collection of Product Quality Complaints.

Call center

Out-of-hours service for collection of product related safety data.