4G Pharmacovigilance
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| Type | Private |
| Headquarters | UK-based |
"4G Pharmacovigilance LLP is a UK-based pharmacovigilance service provider that support pharmaceutical and biotechnology companies in Europe, US, Canada and Asia. Their expertise covers both the clinical and post-market arenas.The company provides a comprehensive PV service, including Qualified Person for Pharmacovigilance (QPPV), which is tailored to suit individual companies' requirements.The company is fully compliant with ICH, FDA and EMEA standards " [1]
Contents
LEGAL BASIS OF PHARMACOVIGILANCE
The pharmacovigilance regulatory obligations placed on MAHs are laid down in Council Regulation EEC 2309/93, Council Directive 75/319/EEC and Commission Regulation EC 540/95. The legal basis for pharmacovigilance inspections at a National level is laid down in Chapter V, Article 26 of 75/319/EEC.
Pharmacovigilance guidelines have been provided in Notice to Marketing Authorisation Holders and will be published in Volume IX of The Rules Governing Medicinal Products In The EU.
The MAHs should ensure that they have an appropriate system of pharmacovigilance in place in order to assure responsibility for their products on the market and to ensure that appropriate action can be taken, when necessary. This includes the MAH having at its disposal continuously at least one appropriately qualified person responsible for pharmacovigilance available at all times within the European Economic Area (EEA), and the establishment of a system for the collection, preparation and submission of expedited adverse drug reactions (ADR) and periodic safety update reports to competent authorities. Pharmacovigilance regulatory obligations are placed on all MAHs. The obligations are the same whether the MAH is an innovative pharmaceutical company, or a generic company.
Drug safety services
We provide a complete package of drug safety services which are specifically tailored to meet your needs.A drug safety specialist is involved in drug safety management such as conducting clinical trials, medical supervision, keeping a check on all the applicable regulations and SOPs (Standard Operating Procedures). Some even work in co-ordination with chief medical directors.
4G Pharmacovigilance provides drug safety services that include the full management of adverse events originating from pre- and post-authorization studies and spontaneous reports, access to a validated drug safety database, expedited reporting in accordance with the national and international requirements, medical information services, writing services of all safety-related documents, and support in creation and management of your standard operating procedures.
They also prepare periodic safety update reports, annual safety reports, risk management plans, responses to regulatory authorities' queries, and any other safety related documents.
Their drug safety team operates in compliance with all regulations and international standards, including ICH, FDA and EMEA.
The roles include activities like :
- Processing and writing of adverse event program
- Follow up on important case reports
- Serving as a link between company and the patients or healthcare experts to provide valid information on product safety.
- Conducting regular pharmacovigilance developments and supervising these processes.
- Attending several meetings related to product safety
- Adding value to any business through product safety functionality.,,
Integrated Services
4G Pharmacovigilance company provides integrated pharmacovigilance services that include the following:
- Whole system setup: Supporting your company's safety projects and representing your company in dealings with health authorities, from initially creating a complete system compliant with GCP, ICH, GDP/GMP, and 21CFR part 11, through to improving the existing setup that will stand up to scrutiny from European regulatory authorities and international regulations enforced by the EMEA and FDA.
- Standard Operating Procedures (SOPs): Designing all safety-relevant SOPs specifically for companies and in compliance with all regulations and quality standards.
- Validated database: Providing clients with access to a validated E2B-compliant database which will be a flexible, efficient, and cost-effective way to centralise all your safety data. They also provide validation services to validate your existing database setup.
- Electronic (E2B) reporting via Eudravigilance Web (EVWEB): Reporting of any appropriate safety cases to the health authorities via EVWEB. Electronic reporting has been mandatory since November 2005 and we are certified EVWEB users.
- Measuring regulatory compliance: Monitoring and documenting the compliance of case-reporting to regulatory authorities.
- Medical information service: We can create a bespoke database, develop report(s) for our clients regarding monthly inquiries, provide standard letters, offer a regular backup service for data documentation and provide answers to FAQs.
- EU Qualified Person for Pharmacovigilance (QPPV): Our drug safety experts are EU qualified persons, which is mandatory as presented in volume 9A.
- Training: They can train your staff and investigators on the latest safety standards and regulations. As per volume 9A, we can ensure that all staff within your organisation are appropriately trained to industry standards.
- Licensing agreements: They are able to prepare and improve existing safety data exchange agreements for the exchange of safety data between you and your licensing partners.
Safety Reports
4G Pharmacovigilance company states that their experienced drug safety and medical writing personnel will be preparing all safety reports. They will ensure that safety aggregated reports are well-written compliant with the latest standards and delivered on time.
The documents we currently prepare include:
- Periodic Safety Update Reports (PSURs): We have extensive experience in preparing 6 monthly through to 3 yearly PSURs and renewals (and associated Bridging Reports and Addendum Reports).
- Risk Management Plans (RMPs): With proactivity in drug safety now obligatory, we have experience in the preparation of RMPs to comply with European standards, as well as creating Risk Evaluation and Mitigation Strategies (REMs) to satisfy US requirements.
- Ad hoc responses to health authorities.
Safety Operations
4G Pharmacovigilance company states that their team has experience working on different databases such as Argus, ARISg, Oracle AERS, Clintrace and various in-house databases.
Furthermore, their operations include:
- Case processing (data entry, narrative, causality assessment and MedDRA/WHO coding)
- Literature monitoring
- Quality control
- Follow-up requests
- Reporting to health authorities
- Data reconciliation
- Compliance measurement
- Regulatory intelligence
- Pharmacovigilance training
- Medical information
- Auditing services
- QPPV services
- Pharmacovigilance consulting
- Process analysis and re-engineering
- Project and programme management for IT and process change initiatives
- Computer systems validation (CSV) in GxP environments
Verification history
2,204 days ago- 2,212 days ago
- 2,212 days ago
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