EU National Requirements of Pharmacovigilance Contact Person (LQPPV)
A table of requirements by country
Addendum to Clinical Overview (ACO)
ACO is a PV doc that has to be reviewed by an EU QPPV & signed by a Clinical Expert...
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.
Towards Brexit: how MAHs can prepare for the UK’s EU exit
EMA and EC have published documents relating to Brexit, to help pharmaceutical companies prepare for the UK’s exit from the EU: a Q&A for Centralised Procedures, and two documents from CMDh .
Infographic: Case Processing Flow
ELC Group provides a full range of case processing solutions to help manage the safety profile of marketed pharmaceutical products.
Infographic: PSUR - Periodic Safety Update Report
PSURs are mandatory reports providing regular analysis of the risk-bene?t of marketed pharmaceutical products.
Infographic: Pharmacovigilance Performance Indicators
The organization may use performance indicators to continuously monitor the good performance of pharmacovigilance activities in relation to the quality requirements.
Infographic: Management of Adverse Drug Reaction
Adverse drug reaction (ADR) is an unintended and potentially harmful response to a medicinal product. ADRs may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure.
Case study: Global Pharmacovigilance Auditing Program
Brochure: Pharmacovigilance Outsourcing
ELC Group provides scalability, expertise, governance, and flexibility built to cater the needs of small, medium, & large pharmaceutical companies to ensure optimal pharmacovigilance compliance.
Introducing a Hormonal Based Medicinal Product
This large EU-based pharmaceutical organization wanted to introduce its combined hormonal-based medicinal product that provides targeted treatment delivery in a constant concentration to the market.
Combination Product Licensing Strategy
This mid- to large-size global generic pharmaceutical organization wanted to introduce a new generic therapeutic drug plus delivery device combined product – a market first – initially into the EU. ELC Group navigated the complex challenge of devising a combined licensing strategy that would fast track entry to European country markets.
Dossier Lifecycle Maintenance
Following its acquisition of an extensive approved product portfolio from one of the top three pharmaceutical companies in the world, this medium-size pharmaceutical organization needed to find a partner capable of undertaking a comprehensive menu of lifecycle maintenance activities on its behalf.
Licensing a New Dosage Form
Having developed a unique new oral dosage form for a well-known over-the-counter pain management product, this small- to mid-sized EU-based pharmaceutical organization wanted to get its innovative product – which offered an enhanced proposition for adults and children – licensed quickly within the EU.
Referral Management Service
When this generic international pharmaceutical company found its promising pan-European license application suddenly encountering an unexpected problem, it turned to ELC to navigate the complex referral process and get back on track to achieve the all-important approvals it needed to go to market.
Scientific Advice Service
When an Asia-based pharmaceutical company wanted to speed time-to-market for its generic to a leading brand-name drug, it engaged ELC Group to help to get the product successfully launched in European markets on its first submission – and as the first in its Market.
Complete Pharmacovigilance Solution
A generic pharmaceutical company looked to ELC Group’s experience and expert knowledge to help reduce operational costs, meet key regulatory deadlines and ensure continuing compliance across its global portfolio of products.
Leading pharmaceutical company uses elc group to achieve marketing authorisation for a new cardiac treatment in multiple EU states.
Mutual Recognition Procedures
ELC group helps leading pharmaceutical company to fast track EU marketing authorisation for a neurodegenerative disease drug.
Pharmaceutical company turns to elc group to navigate EU biowaver approvals for a new generic drug.
CMC and Manufacturing Compliance
Leading global life sciences organization maintains GMP standards by outsourcing supplier audits to ELC Group.
CMC and Manufacturing Compliance
ELC Group helps leading pharma company pass FDA inspection with flying colours.
This international drug manufacturing company turned to ELC Group’s team of translation experts to generate high quality product information documentation that met the exacting requirements of a Scandinavian regulatory agency and would enable the company to achieve marketing approval in a key European national market.