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 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.
- Pharmacovigilance audits
New for 2017: Medical Information Service
To complement our comprehensive suite of Pharmacovigilance solutions and deliver extended value to our pharmaceutical customers, ELC Group now provides a Medical Information Service, for managing product compliance/queries from healthcare professionals and consumers.
Our experienced and qualified healthcare team is able to receive, triage, and respond to all telephone calls, emails, and faxes requesting information about medicinal products. Spanning basic product information for patients to providing more specialised knowledge for healthcare professionals, we deliver an exceptional standard of support for marketed products throughout the product lifecycle.
Located at the heart of our Pharmacovigilance department – where our specialists are providing multilingual services to over 120 countries – our Medical Information team delivers a fully-compliant solution to support our clients’ commitment to patient safety and the highest levels of customer service.
Key features of our Medical Information Service include:
- fulfilling all in-bound medical inquiries (receiving, triaging, and responding to telephone calls, emails, and faxes requesting information about medical products)
- delivering customised responses (performing literature surveillance and providing customised, compliant responses to medical inquiries from healthcare professionals)
- handling product quality complaints
- generating and forwarding standard response letters (FAQs)
- creating and maintaining Medical Information Websites for self-service requests and publication of standard responses/FAQs
Our integrated response centre is available 24/7, offering an excellent standard of oral and written communication in English and other local languages. Our experts have access to the most up-to-date scientific literature and medical research databases, enabling them to provide professional, timely, and accurate responses that meet internal and external standards and regulatory guidance.
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.