Pharmacovigilance & Medical Information Service
Our EMA, FDA and ICH compliant pharmacovigilance (PV) solutions enable bio/pharmaceutical companies to meet their clinical and post-marketing PV obligations in a robust, cost-effective and compliant manner.
Using our experience, expertise and intimate knowledge of the internal workings of PV and regulatory agencies and workgroups, we’re able to ensure you remain compliant.
Our PV cloud service gives you a simple yet transparent approach to undertaking PV electronic reporting in a manner that meets the needs of regulatory authorities. Our full service provision includes a PV system, appropriately qualified personnel plus database. Alternatively we can combine modified elements of the system to match your exact requirement.
ELC Group's Global Quality Management Systems (GQMS) are certified under ISO-9001:2009 (granted by ITC Zlin Czech Republic, and audited annually). Our Pharmacovigilance System is integrated into the GQMS and managed by PV-QA personnel. Periodic self-inspections and audits (either internal or external agency) are conducted to assure effective implementation of quality systems. Our change control process involves approval by the QPPV/deputy QPPV/Head-PV and is monitored and CAPA tracked.
All personnel (including contractors) involved in the Pharmacovigilance activities are appropriately trained for performing the related activities including all staff that may receive or process safety reports. This is a continuous process with annual tailored training programmes and ad-hoc training for specific legislative changes. All training is documented and managed by the QPPV.
ELC Group provides comprehensive pharmacovigilance coverage to over 120 countries, including QPPVs or Local QPPV or local responsible person or National Safety Contacts to fulfil the national legislative requirements and maintain good pharmacovigilance practice compliance.
- Medical information
- Medical Inquiries
- Product Complaints
- Customised Responses
- Case Processing
- Receive and triage serious and non-serious AE cases, performing detailed case entry and follow-up, narrative writing, quality reviews and medical review, to enable on-time reporting.
- Provides safety specialists and physicians to manage the SAE reporting and identify suspected unexpected serious adverse drug reactions (SUSARs) and enable on-time reporting to regulators, investigators and review board/ethics committee.
- Signal Management
- signal detection, validation and evaluation for all products, including label update and review for any identified and potential signals.
- QPPV (Qualified person for pharmacovigilance)
- QPPV, Deputy QPPV,
- Local QPPV,
- Local safety responsible person)
- Establishment and maintaining of pharmacovigilance systems
- validated safety database.
- Pharmacovigilance system master file (PSMF)
- Pharmacovigilance trainings
- Medical Writing
- (Annual updates),
- aggregate reports PSUR/PBRER, PADER,
- Risk management plans, REMS
- Literature search
- Literature search and review for reports of adverse events for all types of products, using standard terms, triage analysis, and relevant processing for expedited or periodic reporting.
- Audits/Training/Inspection Readiness
Infographic: Qualifed Person Responsible for Pharmacovigilance (QPPV)
The 12 Key activities of EU QPPVs...
Infographic: What is a Safety Variation?
Summary of Product Characteristics and Package Leaflets (SmPCs/PLs) are a key part of the MA of all medicines, and the basis of information for healthcare professionals on how to use a medicine safely and effectively.
Infographic: Contractual Agreements in Pharmacovigilance
The overview of all individual contractual agreements must be part of the pharmacovigilance system master ?le (PSMF). Any product speci?c information can be added or modi?ed as an addendum to the existing agreements.