AxeRegel offers the following vigilance consulting services
Pharmacovigilance and drug safety services:
- ICSR (Individual Safety Case Report) management
- Provision of EU QPPV / Deputy EU QPPV services
- Local Qualified Person for Pharmacovigilance (LPPV) or Local Safety Officer (LSO) or local drug-safety-responsible (LDSR) officer
- Setting up the Pharmacovigilance system
- Optimisation of the existing Pharmacovigilance system
- Provision of local pharmacovigilance responsible person
- Preparation and maintenance of the Pharmacovigilance system master file (PSMF)
- SOP reviewing / writing
- Preparation and maintenance of Safety Data Exchange Agreements (SDEAs)
- Conducting pharmacovigilance audits
- Preparation for regulatory inspections
Case processing and report
- Management of ICSR
- Signal detection
- Risk management plans
Food supplements vigilance services:
- Management of adverse events
- Reporting of adverse events
- Preparation of summary reports
- Nutrivigilance SOPs preparation/review
Medical devices vigilance services:
- Preparation of technical dossiers
- Evaluation and management of materiovigilance incidents
- SOPs preparation/review
- Preparation/review of contracts (vigilance clauses)
- Liaison with the Authorities
- Regulatory assistance
Cosmetic products vigilance services:
- Evaluation and monitoring of cosmetic complaints related to marketed products
- Evaluation of undesirable effects
- Reporting of undesirable effects or product safety-related issues to the French Authorities
- Safety assessments including cosmetic products safety reports (CPSRs) for EU compliance
- AxeRegel can also provide the services of a responsible person
EU QPPV and Local Persons for Pharmacovigilance
AxeRegel’s pharmacovigilance services for Marketing Authorisation Holders (MAH) includes the provision of an EU QPPV and of a Local Qualified Person for Pharmacovigilance (LPPV) or Local Safety Officer (LSO) or local drug-safety-responsible (LDSR) officer roles in France.
AxeRegel regulatory watch
Clinical trials in human medicines are studies carried out in human volunteers intended to investigate the safety or efficacy of one or more investigational medicines.
The way clinical trials are conducted in the EU has undergone a major change when the EU Clinical Trial Regulation (CTR) (Regulation (EU) No 536/2014) entered into application on 31 January 2022.
The ACT EU initiative launched by the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) on January 2022 aims to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.
The ACT EU workplan was updated on 30/08/2022, it sets out deliverables and timelines for the project from 2022 to 2026....Read more.
How to manage the impact of the war in Ukraine on clinical trials?
The war in Ukraine is causing disruptions in the conduct and planning of clinical trials. Although these disruptions are most severe in Ukraine, other countries are also affected, for example due to the arrival of refugees fleeing Ukraine or the impact of imposed sanctions.
Although in the EU, clinical trials are authorised and supervised at national level, the EMA plays a key role in ensuring that Good Clinical Practice (GCP) standards are applied throughout the European Economic Area (EEA) in cooperation with the Member States....Read more.
European Good Pharmacovigilance Practices (GVP) on specific Risk Minimisation Measures of the pregnancy prevention program
This new guideline, currently under public consultation, defines the elements of the pregnancy prevention programme and specifies when such a programme or other risk minimisation measures are necessary to prevent the adverse consequences of taking medicines during pregnancy and to protect the health of the mother and the child.
The Pregnancy Prevention Programme (PPP) is a set of :
- routine measures of pharmacovigilance, and
- additional Risk Minimisation Measures (RMM)