Drug safety during clinical development and post approval
The monitoring of clinical trial safety and the constant surveillance of market medicinal products are vital responsibilities for pharmaceutical companies. The regulatory requirements related to pharmacovigilance have become more and more complex in recent years and specialist knowledge and increasing resources are needed to fulfil these obligations.
Pharmacovigilance services offered by HilbransConsulting include:
- Advice on regulatory requirements/ regulatory compliance
- Implementation of pharmacovigilance systems according to GVP
- Support with regard to compilation of Pharmacovigilance system master files (PSMF)
- Processing and medical evaluation of single case reports (SAE/ICSR)
- Generation of aggregate safety reports (DSURs, PSURs) and Risk Management Plans (RMPs)
- Literature search, review and evaluation
- Signal detection and evaluation
- Advice on safety labelling (SmPC/Core Safety Information)
- Assistance with pharmacovigilance agreements in contractual relationships
- Support of safety data base implementation
- Pharmacovigilance training