Pharmacovigilance
Pharmacovigilance is the science related to risks of medicinal products / drugs and how to minimise them
More about pharmacovigilance
Pharmacovigilance is a term that consists of two parts - the Greek pharmakon (remedy, poison, miracle cure) and the Latin vigilantia (attentiveness, care).
Pharmacovigilance (drug safety, drug surveillance) deals with the surveillance and evaluation of known and potential drug risks. The aim is to detect risks due to side effects or interactions as early as possible (or to minimise them as early as possible, respectively) in order to increase patient safety.
The legislative framework on international, European and national (e.g. German) level is complex in this discipline, and subject to frequent revisions.
Pharmacovigilance (or the benefit/risk ratio of drugs, respectively) is a key element within pharmaceutical medicine. PV plays a major role in both, the clinical development phase of an investigational drugs (clinical safety) and the phase from the authority approval of the drug onwards (post-authorisation safety).
BoosConsulting is well-versed in both drug safety areas and able to cover your development compounds as well as your established products.
- Description of the pharmacovigilance system in the Pharmacovigilance System Master File (PSMF)
- Implementation of national / international legal pharmacovigilance requirements (e.g. ICH, Good Pharmacovigilance Practices / GVP)
- Developing and establishing company-internal global pharmacovigilance standards
- Setting-up / Optimizing PV systems in affiliates
- Development and revision of process descriptions (SOPs, WIs) and templates
- Taking on interim positions
- Strategic PV planning
- Support with resource management and personnel recruitment
- Support with budget and cost centre planning / maintenance
- European Qualified Person for Pharmacovigilance, EU QPPV (or Deputy)
- German Graduated Plan Officer acc. to §63a German Drug Law (or Deputy)
- Cumulative signal detection and evaluation
- Benefit-risk assessments of medicinal products
- Preparation of risk management plans (RMPs) including Risk Minimization Measures
- Support in / Management of medical alert situations
- Preparation and follow-up of Regulatory Inspections and internal PV Audits, including CAPA development / management
- Support with authority notices of deficiency, European risk procedures (Referrals)
- Preparation of Periodic Safety Update Reports (PSURs)
- Preparation of annual safety reports in the context of clinical trials - Development Safety Update Reports (DSURs)
- Pharmacovigilance training for PV and non-PV staff
- Training in medical-scientific content
- Medical-scientific presentations
- Preparation of annual safety reports in the context of clinical trials - Development Safety Update Reports (DSURs)
- Support with documents within the framework of
- clinical trials (Clinical Trial Protocols, Safety Reporting Plans, Case Report Forms, Marketing Authorisation Application documents, Investigator's Brochures),
- non-interventional studies (NIS),
- PASS/PAES (post-authorization safety studies / post-authorization efficacy studies)
- Medical case assessment for adverse event reports from clinical trials and/or post-marketing experience (ICSRs) for established drugs and development substances
- Answering product-specific medical-scientific inquiries from patients, pharmacists, and physicians
- Creation/maintenance of safety profile documents (e.g. CCDS, CCSI, SmPC)
- Expert statements on requests from Health Authorities
- Medical Writing (e.g. for regulatory affairs, medical affairs)
- Processing of complex medical-scientific content (e.g. in the context of expert opinions)
BoosConsulting - the
Booster for your Pharmacovigilance System!