Pharmacovigilance
The professional experience offered by HilbransConsulting GmbH includes profound knowledge in regulatory requirements within the EU, managing drug safety departments as well as implementing and maintaining effective pharmacovigilance systems. Specialised expertise is available for generating periodic safety reports and risk management plans and for routine safety reporting including medical evaluation and coding according to MedDRA terminology.
Clinical Research
The experience regarding drug safety aspects in clinical development includes medical input in the planning of clinical trials, compilation of clinical trial documentation and monitoring safety of trial subjects. Experience was also gained in establishing Data Monitoring Committees and in providing drug safety training to clinical trial personnel.
Quality Management
We are specialised in auditing pharmacovigilance systems and processes and in preparing companies for regulatory authority inspections. Furthermore, expert knowledge is offered in implementing effective quality management systems for pharmacovigilance and GCP activities, taking into account workflow optimisation and regulatory compliance. This includes the generation and implementation of SOP systems and training of personnel.