Pharmacovigilance

According to the European Legislation requirements, all Marketing Authorization Holders must employ a full-time QPPV (Qualified Person for Pharmacovigilance). MAHs may alternatively subcontract certain activities of the pharmacovigilance system to third parties, such as SustChem S.A.
The QPPV is responsible for the preparation and maintenance of MAH’s pharmacovigilance system and carries the responsibility for ensuring compliance with all EU regulatory requirements relating to PV for MAH’s products.

The major responsibilities of the QPPV, as being dictated by both the contractual arrangement and the legal requirements are:
• Continuous assessment of the risk –benefit balance of MAH’s active substances
• Maintenance of the Pharmacovigilance system updated and fully competent
• Awareness of all MAH’s regulatory obligations
• Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the competent authorities in Members States and the Agency
• Acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections.
• Monitoring of the performance and effectiveness of the PV System

According to the amending Directive 2010/84and the Regulation 520/2012, MAHs are obliged to maintain a pharmacovigilance system master file (PSMF). The PSMF must include the description of the pharmacovigilance system and all documents supporting its compliance with the legal requirements. PSMF shall also contribute to the appropriate planning and conduct of audits by the applicant or marketing authorisations holder(s), the fulfillment of supervisory responsibilities of the QPPV, and of inspectionsor other verification of complianceby national competent authorities.

The purpose of Standard Operating Procedures is to ensure the proper functioning of the Quality Assurance system. Each SOP must cover a significant pharmacovigilance topic, eg Processing of Adverse Reactions, PV training, Signal Detection etc. Our team compiles & updates each MAH’s SOPs taking under consideration his ISO system, his Internal Management System & all potential risks rising from the continuous safety assessment.

ICSR collection and processing is one of the major QPPV’s responsibilities and serves as the basic tool for safety surveillance. Only trained and qualified personnel is authorized to process ICSR reports and is responsible for complying to the appropriate deadlines of reporting. SustChem S.A. provides an integrated system of collecting, processing and reporting ICSRs in the Eudravigilance 24/24h – 7/7 days.

Scientific and medical literature plays a key role in assessing the risk-benefit ratio, as well as to identify suspected adverse reactions with medicines authorized in the European Economic Area (EEA). SustChem Personnel is constantly monitoring scientific and medical databases and updates literature archives for each API on a weekly-base.

Every new or even known adverse event caused by a medicine, with high incidence rate, constitutes a potential safety signal and requires further investigation. Signal Detection & Management is a long-term procedure with high demands. SustChem S.A. provides constant monitoring for signal detection, statistical analysis, data collection and review, management of open Safety Signals, Safety Communication with the Professional (DHPC), communication with Competent Authorities etc.

PSURs play a significant role in pharmacovigilance because they provide an evaluation of the benefit-risk balance of a medicine. MAHs are obliged to submit PSURs at defined time points following a medicine’s authorization. SustChem S.A. is responsible for monitoring Eudralist for the identification of required time points of submission for each product. SustChem SA also compiles and submits PSURs according to the regulatory requirements.

An audit system, both internal and external, can be critical for the proper Pharmacovigilance function.
All SustChem S.A. personnel organizing and participating in the internal audits complies to the IIA International Standards for the Professional Practice of Internal Auditing and are members of the Institute of Internal Auditors (IIA). Moreover, the aforementioned personnel participates in the annual conference of IIA Greece and in specific training sessions organized by the Institute.

All MAHs employees must be trained on proper pharmacovigilance. Custom-made training sessions are scheduled by SustChem S.A. annually for each MAH. Additional training sessions are held in case of regulatory modifications or new staff recruitment.

Safety Data Exchange Agreements (SDEA) are established between MAHs and/or distributor and/or licensee participating in a common authorization procedure, in order to exchange safety data about product’s safety surveillance.

Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA) and sponsors of clinical trials must register to the Eudravigilance for the electronic data interchange of pharmacovigilance information.

According to the Article 57, Regulation 726/2004 (EC), for all medicinal products appropriate data must be submitted using the XEVMPD module, within 15 calendar days from the notification date of the marketing authorization. All data must be updated following transfer, suspension, renewal, variation, revocation or withdrawal no later than 30 calendar days from the date on which the amendments have been authorized. SustChem Personnel is trained and qualified in how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 database.

Apart from registering Pharmaceutical Companies in the Eudravigilance, Sustchem also undertakes all procedures for the qualification of the Company as micro, small- or medium-sized enterprise (SME) according to the Regulation (EC) No 2049/2005. All SME companies receive significant fee reductions or deferrals, as well as administrative and procedural assistance from the SME office and waiver of the MedDRA licensing fee.