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| Expertise |
Verum.edu has expertise in R&D field and in special aspects related to Romanian regulatory environment. Verum.edu specialists are involved in different activities related to clinical trials:
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Training and education:
- for disseminate information regarding Romanian R&D Verum.edu specialists held presentations at IIR London, IBC London, Management Forum London, European Forum of Good Clinical Practices Brussels (titlu link: Romania plays to its regulatory strengths - GCP Journal September 2005 issue)
- for enhance quality in clinical trials conducted in Romania, Verum.edu specialists trained the personnel involved in clinical research at Romanian Lilly Forum and Investigators Meetings.
Auditing:
- Verum.edu has specialists with more than 50 GCP inspections and audits in CEE countries (Romania, Bulgaria, Ukraine, Hungary, Czech Republic) and with expertise in conducting pharmacovigilance inspections.
Quality Assurance:
- Verum.edu has trained specialists with expertise in design and implementation of standard operating procedures (SOPs) in different institutions and companies involved in conducting or inspecting clinical trials in CEE.
Regulatory activities: Verum.edu has expertise in:
- registration and notification of medicinal products at Romanian regulatory bodies: National Medicines Agency and Ministry of Health;
- ranslation and implementation of new European GCP legislation in Romanian laws
Entrepreneurial expertise:
- Verum.edu specialists were involved in setting up of GCP and pharmacovigilance inspection activities in Romania
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