Drug Safety Solutions Pharmacovigilance and Regulatory Support Services for Drug Development
Drug Safety Solutions (DSSL) provides pharmacovigilance consultancy and support services to ensure pharmaceutical developers meet industry regulatory requirements.
The company consistently updates its regulatory knowledge to keep up with industry trends. Its team of experts provide consultations on a wide range of pharmacovigilance topics, including preparation for process reviews and audits, database management, and the creation of standard operating procedures (SOP) and risk management plans (RMP).
Pharmacovigilance system review and audit preparation
DSSL reviews pharmacovigilance systems to identify gaps and optimise communication, monitoring and risk assessment strategies.
The company implements any necessary changes to meet regulatory timeframes, including drafting and implementing SOPs, monitoring change control processes and collating required documentation.
DSSL also carries out routine mock audits through an independent auditor and offers pre-inspection audit training.
The preparation and implementation of post-audit and post-inspection corrective and preventative action plans (CAPA) are also available.
Risk management plans, databases and SOPs
DSSL prepares risk management plans, databases and SOPs to meet the requirements of relevant regulatory bodies.
The company helps validate and implement databases that meet both regulatory and client requirements and support pharmacovigilance systems. The company can also accommodate clients’ data into its own fully validated pharmacovigilance database, PV Works, which provides easy set-up, validation, maintenance and data entry.
DSSL also assists in the preparation of SOPs to ensure regulatory obligations are fulfilled, personnel are trained and tasks are accurately documented.
The company’s draft risk management plans are designed to conform to the template published by the European Medicines Agency (EMA).
Outsourcing of pharmacovigilance processes and QPPV activities
DSSL provides outsourced pharmacovigilance solutions to reduce costs for small and medium-sized companies experiencing unexpected increased workloads, staff vacancies or a temporary lack of resources.
The company offers an experienced qualified person for pharmacovigilance (QPPV) to perform a wide range of activities, including the creation of the pharmacovigilance system master file (PSMF), case processing, reporting, literature reviews, maintenance of safety information, safety monitoring and signal detection.
Case management, ICSR processing and remote data entry
DSSL offers case management and individual case safety report (ICSR) services, including triaging, coding, data entry, quality control, medical reviews, expedited reporting cases to the authorities, and electronic reporting and reconciliation.
The company is experienced in data entry for a range of databases, including ARISg™, Clintrace, PV Works and Microsoft Excel.
Electronic reporting to the regulatory authorities
DSSL’s staff are experienced with EudraVigilance Webtrader, and the receipt of ICSRs and suspected and unexpected serious adverse events (SUSAR).
The company’s electronic reporting services include:
- Registering companies to EudraVigilance as QPPV or a trusted deputy
- Electronic transmission of ICSRs and SUSARs to competent authorities through EudraVigilance
- Entering medicinal products into the eXtended EudraVigilance Medicinal Product Dictionary
Literature searching services
DSSL’s literature searching solutions offer weekly reviews of reference databases using PubMed or routine in-house investigations. The company also documents all outcomes, as well as identifies case reports and other relevant citations in preparation for periodic safety update reports (PSUR) and signal detection.
DSSL also reviews the EMA’s Medical Literature Monitoring (MLM) output in a custom-made report.
Pharmacovigilance support services
DSSL’s support services assist with a wide variety of tasks, including pharmacovigilance system master file (PSMF) preparation, safety monitoring and signal detection, maintenance of periodic reports, and clinical trial and SUSARS management.
The company writes and reviews a range of documentation, including drug safety update reports (DSUR), periodic safety update reports (PSUR), periodic benefit-risk evaluation reports (PBRER) and management reports. Due dates can be coordinated to ensure that the documents are submitted to the regulatory authorities within legislated timelines. DSSL also prepares, implements and maintains standard safety data exchange agreements.
DSSL designs comprehensive safety review processes for products. This is a common cause for failed inspections and companies with generic or over-the-counter (OTC) products can find it difficult to ensure compliance, so DSSL simplifies review processes to prepare for safety audits.
DSSL offers management of clinical trial serious adverse events (SAE), from case assessment to electronic reporting to the regulatory authorities.
DSSL has a range of courses to train staff to perform pharmacovigilance activities. They are suitable for pharmacovigilance department staff, sales personnel, clinical research staff, receptionists, telephone switchboard operators, and any other staff member that receives or processes safety reports.
DSSL can provide:
- Basic training of all staff either in person or through online or remote packages
- Specialised training of pharmacovigilance staff
- Training on specific topics, including RMPs, PSMFs, PBRERs, PSUSs, case processing, EudraVigilance, literature reviews and the EMA’s MLM
- Pre-inspection training
- Mentoring of senior pharmacovigilance staff or QPPVs
About Drug Safety Solutions
DSSL was founded in 2002 by Carol Markwell. The company utilises her experience in all aspects of pharmacovigilance and she has worked for more than 15 years in roles within international pharmaceutical companies. In addition, she completed a post-graduate diploma in pharmacovigilance at the University of Hertfordshire in 1997.
The company’s team of dedicated medical professionals are committed to providing an efficient service in all areas of pharmacovigilance. Its client base comprises small and medium-sized innovative companies, generic pharmaceutical firms and commercial sponsors.