Pharmacovigilance

Quality Management System

The Quality Management Systems (QMS) at ELC is managed by the Quality Assurance department. ELC global quality management system is ISO-9001:2015 certified.

The PV system, with its own structure, processes, procedures and responsibilities, is fully integrated in the QMS ensuring appropriate resource, compliance and record management.

We offer:

• The creation and maintenance of Standard Operating Procedures (SOPs) and Work Instructions
• Training and records management
• Deviation and corrective and preventative action (CAPA) management
• Audits
• Inspection readiness
• Recordkeeping and document management

QPPV – Qualified person for Pharmacovigilance

As part of the PV system, the marketing authorisation holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (QPPV) in the EU [DIR Art 104(3)(a)].

The marketing authorisation holder shall ensure that the QPPV has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorisation holder [IR Art 10(2)].

ELC has highly qualified QPPVs with adequate theoretical and practical knowledge for the performance of PV activities. The QPPVs are skilled in the management of PV systems as well as expertise (or access to expertise) in relevant areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics.

At ELC we have three QPPVs based in the EU (including the UK) and we provide local QPPV/PV contact person services to all EU countries.

We offer:

• EU QPPV
• Deputy QPPV
• Local responsible person (LRP) for PV at national level

Pharmacovigilance system coverage

At ELC we have PV experts with a thorough knowledge of European Medicines Agency (EMA), Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) guidelines. Our experts have successfully handled European, MHRA, USFDA and Health Canada inspections.

ELC has experience providing end to end PV services in the following regions:

• European Economic Area
• United Kingdom
• Switzerland
• USA
• Australia

ELC has experience providing end to end PV services in the following regions:

• Provision of the summary of PV system for application
• PV system master file (PSMF) creation and maintenance for EU and India region
• Maintenance and validation of safety database

Literature search

The medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.

We offer:

• Global/local literature search and review for reports of adverse events for all types of products, using standard terms
• Triage and processing all valid case reports (ICSRs)
• Monitoring of literature for aggregated reports and safety information

Case processing

At ELC, we have experts in handling case processing including the submission of Adverse Drug Reaction reports and submissions for EMA, USFDA, Therapeutic Goods Administrations (Australia), Health Canada, and other ROW markets.

ELC uses a global safety database compliant with ICH, EMA and FDA regulations and directives related to reporting of adverse events:

• ICH E2B R3 compliant
• US FDA 21 CFR part 11
• EMA’s good pharmacovigilance practice (GVP) guidelines

Some of the key features of the safety database include but are not limited to:

• Availability of all E2B specified fields and customer specific attributes
• Integrated MedDRA browser
• Duplicate check for the new cases
• Case validation based on EMA business rules
• Versioning of cases for follow-up information
• Additional attachments for cases like CIOMS I, MedWatch, email, etc.

It also enables integrated submission management with direct submissions to:

• the EudraVigilance post-authorisation module (EVPM)
• the EudraVigilance clinical trial module (EVCTM)
• NCAs and global trading partners via gateway
• a specific email address or a list of email contact

It also includes complex search functionality which allows specific grouping, filtering and administration of search results:

• Support for CIOMS I, line listings, tabulated summaries, as well as MedWatch reports and configurable reports, etc.
• Simplified signal management
• Integrated workflow engine to assure work in time and task view with warning functionality
• Easy E2B-compliant XML file import and export

We offer:

• Receipt and triage of serious and non-serious adverse reaction reports, performing detailed case entry and follow-up, narrative writing, quality reviews and medical reviews, to enable on-time reporting.
• Provision of safety specialists and physicians to manage the serious adverse events (SAE) reporting and identify suspected/unexpected serious adverse drug reactions (SUSARs) and enable on-time reporting to regulators, investigators and review board/ethics committees.

Aggregated reports

At ELC we have a dedicated team of medical writers experienced in writing various aggregate reports and risk management plans. We have team of 8 medical writers which consists of healthcare professionals and medically qualified doctors.

We offer preparation and submission of following aggregate reports:

• Preparation and submission of Periodic Safety Update Reports: PSUR/PBRER/PADER
• Preparation and updates for risk management plans (RMP)/Risk Evaluation and Mitigation Strategies (REMS) for EU, USA and ROW markets
• Addendum to clinical overview (ACO)
• Development Safety Updates Report (DSUR)
• Annual safety update reports

Signal management

At ELC, we have a dedicated team consisting of medically qualified doctors and healthcare professionals performing signal management. We also have processes for the continuous monitoring of the safety profile of authorised medicinal products, risk-benefit assessment, reporting and communication with competent authorities and healthcare professionals, changes to the risk-benefit balance of products – ensuring they are in line with the requirements as set out in good pharmacovigilance practices (GVP) Module IX – Signal Management. The signal management process also involves the use of EudraVigilance data and the screening of electronic reaction monitoring reports (eRMR).

We offer:

• Signal detection, validation, evaluation including review of Pharmacovigilance Risk Assessment Committee (PRAC) recommendations, analysis of database generated reports for the events in the reporting period and cumulative period, published literature, review of regulatory websites and monitoring of EVDAS.
• Proposal of appropriate actions and safety review meetings

Business partner and service provider management

Safety Data Exchange Agreements (SDEA) are legal written contracts ensuring that all safety information related to a registered medicinal product is received by the marketing authorisation holder to fulfil the legal obligations to submit safety reports in a timely manner.

SDEAs are prepared between different stakeholders such as:

• Marketing authorisation holder and manufacturers
• Marketing authorisation holder and MAH licensing partner or cross-licensing partner
• Marketing authorisation holder and distributors

SDEA and PV agreement management involves creating and maintaining SDEA and PV agreements for our clients’ business partners, e.g. distributors, manufacturers, licensing partners, service providers, etc.