Volume 9 A Guidelines On Pharmacovigilance[1]
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This document discusses guidelines for pharmacovigilance (PV), which is the monitoring of drugs for safety issues. Some key points: - Clinical trials must have strict ethics and safety protocols to protect subjects and maintain trust. Post-approval monitoring is also important. - Marketing authorization holders are responsible for PV of their approved drugs. This includes reporting safety issues, having a qualified person responsible for PV, and maintaining a detailed PV system. - Competent authorities conduct inspections to ensure marketing authorization holders follow PV requirements. They also monitor for safety signals and ensure timely communication of issues.
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This document summarizes guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regarding pharmacovigilance and clinical drug development. It defines key terms like adverse events and serious adverse events. It also provides overviews of ICH guidelines on topics like safety reporting standards, post-approval safety data management, risk-benefit analysis, clinical study design and conduct, and special populations like pediatrics. The document aims to aid understanding of ICH guidelines for pharmacovigilance and clinical evaluation of pharmaceutical products.
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The document discusses integrating pharmacovigilance quality management systems (QMS) to ensure compliance and quality across various pharmacovigilance processes. It outlines key considerations for establishing a QMS including regulations, metrics, customizing electronic systems, and managing quality for clinical trial data, contracting, inspections/audits, and expedited individual case safety reports. The QMS aims to prospectively and retrospectively monitor quality across pharmacovigilance activities.
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This document discusses data mining techniques used in pharmacovigilance to detect adverse drug reactions. It describes how large pharmacovigilance databases are mined using both frequentist and Bayesian statistical signal detection methods to identify disproportionate reporting of potential drug-adverse event associations. Examples of signals detected over time are shown, such as increasing positive information component scores for paclitaxel-tachycardia and doclitaxel-flushing associations. Statistical data mining is presented as a useful non-invasive tool for detecting previously unknown or incompletely documented drug safety signals.
ICH E2A GUIDELINE
THIS IS ICH E2A GUIDELINE -CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
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Volume 9 A Guidelines On Pharmacovigilance[1]
- 2. Treatment may be worse than the disease
- 3. During the 1990’s, the deaths of two healthy volunteers in the US made their way to the highest political levels and forced a review of protection of human subjects. Ellen Roche 24 year old Healthy Volunteer Asthma study Jesse Gelsing er 18 year old Healthy Volunteer Genetic Study
- 4. In March of 1994, the U.S. Office of Research Integrity announced that Dr. Roger Poisson from Montreal admitted having falsified data (99 cases) in a breast cancer clinical trial sponsored by the U.S. National Cancer Institute (NCI). This well-intended falsification compromised the contribution of hundreds of women enrolled in the protocol as all data from the 389 patients enrolled by Dr Poisson were removed from the analysis. Dr. Roger Poisson
- 6. We need sound science, ethics and safety in clinical trials to sustain the trust of government, public and, especially, the research subjects.
- 8. Thus, in order to have complete assessment of the drug in real life setting, safety reporting in post-authorisation era or pharmacovigilance is equally important.
Editor's Notes
- Ensure u hv a DDPVS ready, correct resources, processes are clearly documented, QC is built in, agreements in place
- Regulation EC) No 726/2004 and Directive 2001/83/EC
- Unknown = Unexpected US – Safety reporting requirements are specified in Title 21