Processing Adverse Events and SAEs||
The scope of this SOP:|
1. Processing of post-marketing adverse events from any source, including but not limited to spontaneous reporting sources, active literature surveillance, phase IV studies, patient registries, and patient assistance programs
2. Processing of serious adverse event reports from client-sponsored phase I, II, and III studies
This SOP begins with the receipt of a potentially valid adverse event report and ends with the appropriate reporting of the adverse event information to stakeholders.
Processing of non-serious adverse event reports from company-sponsored phase I, II, and III studies is out of the scope of this SOP.
The scope of this SOP is the intake and appropriate management of product-related information received from any source (including call center, phone, fax, email, etc.). The information received may involve product complaints, adverse events, medical inquiries, or other subjects.|
This SOP begins with the receipt by the company of product-related information and ends with the routing of the information to the appropriate parties either within the company or to a designee.
The scope of this SOP is routine surveillance of scientific and medical literature in accordance with applicable laws to detect adverse event case reports and other relevant drug safety information.|
This SOP begins with the establishment of search parameters and ends with the receipt of an article or abstract that is ready to be processed.
The scope of this SOP is the preparation and management of US periodic reports, PSURs, IND Annual reports, and DSURs.|
Manual Procedure for Handling Reported Adverse Health Events||
The scope of this SOP is manual processing of adverse event cases when the safety database is unavailable.|
This SOP begins with the determination that manual case processing should begin and ends with the retrospective entering of cases upon the availability of the safety database.
MedDRA Coding Conventions and Dictionary Management||
The scope of this SOP is the consistent application of medically accurate terms when using MedDRA to assign codes to adverse events. The scope also includes the management and administration of medical terminology lists used to classify adverse event information.|
Quality Oversight of Safety Processes||
The scope of this SOP is periodic reviews to ensure that the processes related to patient safety and compliance with all applicable regulations are satisfactorily performed. This SOP also ensures that findings noted during reviews are satisfactorily addressed.|
The scope of this SOP is the establishment and execution of training requirements to ensure that the staff engaged in activities related to adverse event processing is adequately trained.|
Signal Detection and Risk Management||
The scope of this SOP is the assessment of and update to the risk-benefit profile for company products both on the market and in clinical development.|
Escalation of Safety Issues||
The scope of this SOP is the management of the escalation of safety issues both within the company and beyond to all affected stakeholders.|
QPPV Role and Responsibilities||
This SOP describes the role and responsibilities of the QPPV and Deputy for marketed products.|
|DS-012||PSMF Development||This SOP describes the activities and responsibilities required for the preparation, review, approval and maintenance of the Pharmacovigilance System Master File (PSMF)|
|DS-013||Safety Data Exchange Agreements||The scope of this SOP is the preparation and revision of Safety Data Exchange Agreements with business partners and subcontractors of the company.|
|DS-014||Unblinding||This SOP describes the steps for code breaking (revealing treatment assignment), distribution and reporting SUSARs.|
The scope of this SOP is the management, processing, review, approval, and closeout of SOP deviations, planned or otherwise.|
Glossary of Terms||
The scope of this SOP is a global list and associated meaning for commonly used terms and acronyms.|
SOP on SOPs||
The scope of this SOP is the format, responsibilities, approval, periodic review, obsolescence, maintenance, and usage of controlled documents.|
Good Documentation Practices||
The scope of this SOP lists the minimum standards for good documentation practices and ensures that errors are properly corrected and noted as to their nature.|
Management of Inspections||
The scope of this SOP includes the responsibilities, conduct, and activities during the US and European regulatory inspections and post-inspection responses to findings and observations.|
The scope of this SOP is the retention of Product Safety Records.|
|QA-007||CAPA Processes |
|This SOP describes the Corrective and Preventive Action System (CAPA) as it applies specifically to the Quality Assurance (QA) Department audit findings that involve deficiencies or deviations found regarding regulations or established practices and procedures of the pharmacovigilance system activities or any external vendors and/or contractors responsible for outsourced pharmacovigilance activities.|
|QA-008||Regulatory Intelligence||This SOP describes the process to screen and assess new or updated Pharmacovigilance (PV), Clinical, and Regulatory Affairs (RA) regulatory policy documents on a regular basis for potential impact on company procedures, the documentation of the impact analysis, and the monitoring and completion of required implementation activities by the business units involved.|