Pharmacovigilance at Eignapharma
Eignapharma will guide you in the process of achieving a healthy and compliant Pharmacovigilance system, whether in an 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 carefully follow up the future direction of Pharmacovigilance maintaining permanent contact with leading experts and regulatory agents. This allows us to constatnly plan in advance any upcoming changes, thus better protecting your interests.
Pre-Marketing Authorisation Application
Appointment of European Qualified Person for Pharmacovigilance.
Authoring and maintenance of the Pharmacovigilance System Master File.
Authoring and maintenance of the Risk Management Plan.
Marketing Authorisation Holder
Local person for Ph
Appointment of a local Qualified Person for Pharmacovigilance, when applicable.
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.
Management including signal detection and mandatory EVDAS activities as applicable.
Authoring of Periodic Update Safety Reports and subsequent submission to the EMA PSUR Repository.
Mandatory training on Pharmacovigilance to all employees (Induction and Refresh trainings).
Periodic reconciliation of cases/PQCs/medical enquiries exchanged between Parties.
General Data Protection Regulation (GDPR)
Data declaration to the personal data protection agencies.
Medical information services
Handling of medical enquiries.
Social Media monitoring
Screening of social media accounts.
Marketing Authorisation Application
Global scientific literature screening
Regular worldwide literature monitoring.
Local scientific literature screening
Regular 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).
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.
Collection of Product Quality Complaints.
Out-of-hours service for collection of product related safety data.