EMA Pharmacovigilance

EMA Pharmacovigilance

The fulfilment of the requirements and conditions of the EMA data-processing network and pharmacovigilance database EudraVigilance and the implementation of an action plan for risk management in line with the EU pharmacovigilance directives are of the highest priority at Dr. Oestreich Partner GmbH together with strict orientation to the customer’s specific requirements. For well over two decades the Company has conducted pharmacovigilance projects in various medical indications and specialist areas in accordance with the EMA guidelines. Our SOPs reflect the current EMA pharmacovigilance guidance as the standard for our internal work processes. Our expert and highly qualified team has extensive experience in both the medical and requisite technical areas, and is available to assist our customers in EMA-driven pharmacovigilance projects. The identification, documentation, reporting, monitoring and evaluation of events with respect to the safety and tolerability of pharmaceuticals and medical products are all carried out in accordance with the EMA pharmacovigilance requirements. We plan both retrospective and prospective studies to establish any interrelationships between different medicinal products (drug interactions), misuse and other safety profiles. These projects are carried out with careful consideration of the cost-benefit analyses. We also manage the reporting of adverse events to the competent authorities, and the associated long-term monitoring and data management for our customers. In addition, we prepare safety update reports (PSURs) for authorities, analyse medical texts and other sources on medical product safety and summarise study results according to EMA pharmacovigilance requirements.

Click here for an overview on EMA pharmacovigilance:

http://www.oandp-cro.com/clinical-research/product-safety/

Fast transmission of pharmacovigilance data to the EMA

With our internet-based EDC programmes OPVERDI and PMSBOX, we provide our customers with practice-oriented databases, which can be adapted, both in their design and data structure, to the individual needs of all EMA pharmacovigilance studies. Access to our databases is possible via the internet, which means that the systems have high intrinsic flexibility with all authorised users able to view or edit data from any location. These software solutions, which meet regulatory authority requirements, have been in use for more than 10 years. In addition to high reliability, inbuilt error prevention checks and uncomplicated data correction, they permit rapid communication while at the same time ensuring data security for the protection of patients. The databases also enable the easy transmission of data to the EMA (EudraVigilance data processing network and management system) or other EMA pharmacovigilance data collection systems.

Click here for more information on EMA pharmacovigilance:

http://www.oandp-cro.com/clinical-research/product-safety/


EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Pharmacovigilance
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
ICH GCP E6
GCP Guidelines
GCP Compliance
BfArM GCP
Clinical Research Organisation
Contract Research Organisation
PSUR
PSURs
Pharmacoeconomics, Health
Pharmacoeconomic studies
Pharmacoeconomics
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection