About us
PharmaCare Group (PCG) are a specialised Patient Safety service provider offering bespoke, pioneering Risk Management services to the pharmaceutical industry. We have extensive experience with the risk management and inspection procedures that are required in the sector and always keep Patient Safety as our primary concern and motivation when providing these services to the healthcare industry.
Our team consists of pharmacovigilance, medical advisor, risk management, training, commercial and supply chain experts and has extensive experience of working with the originator Risk Management Platform (RMP) & Pregnancy Prevention Platform (PPP) system for Lenalidomide, Pomalidomide and Thalidomide.
We have deep knowledge of the pharmacovigilance responsibilities for both the branded and generic market and are uniquely positioned to assist in projects on medicines with teratogenic side effects and other complex molecules which require a strict Risk Management Programme.
We are proud to announce that in its first year after launch, Pathfinder is a real catalyst with about 100% of NHS trusts’ registration and an increased level of compliance. Pathfinder was awarded a high commendation in Improving Medicines Safety at the Health Service Journal Patient Safety Awards.
Mission Statement:
PCGs mission is to ensure the safe prescribing of molecules by delivering a robust, reliable, real time risk management programme to serve our patients and the wider healthcare community.
Our Values are:
- Integrity: We pride ourselves in ensuring transparency, honesty and accountability in all our business practices and interactions.
- Reliable: PCG is committed to consistently delivering on promises, maintaining dependable operations, and fostering trust through consistent performance.
- Support: PCG is fostering a collaborative and nurturing environment, where all our stakeholders receive the assistance, resources, and encouragement needed going above and beyond to exceed expectations and provide exceptional service.
Our Services
PharmaCare Group Ltd offer specialist Risk Management consulting services relating to pharmaceutical goods with teratogenic side effects and other complex molecules which require a strict Risk Management Programme. Pharmacare Group Ltd (PCG) along with Health Beacon Plc (HB) have developed the Pathfinder portal for which PharmareCare Group is providing administrative and pharmacovigilance services. Pathfinder offers a shared Risk Management Platform (RMP) between different Marketing Authorisation Holders.
Pathfinder
Marketing Authorisation Holders (MAH’s)
Marketing Authorisation Holders (MAH’s) requirements to access a Risk Management Platform at lower cost with a wider potential customer base. Marketing Authorisation Holder (MAH) is an entity or company that holds the legal responsibility for a pharmaceutical product’s marketing authorisation in a specific region or country. MAH obtaining regulatory approval from the respective health authorities.
National Health Services
Regulatory Authorities
Patients
To provide high-standard patient safety service in pharmacare, healthcare organisations, pharmacists, and healthcare professionals must prioritise patient safety and implement various strategies to minimise risks associated with medication use.
Why work with us ?
Our Team
Our directors have experience in the pharmaceutical industry at senior levels both nationally and globally in functions covering supply chain, procurement, commercial, medical affairs / drug safety, and regulatory functions. They have firsthand experience in working with molecules with strict risk management programmes and controlled drugs. The PharmaCare Group team has experience of working with the originator Risk Management Platform (RMP) and Pregnancy Prevention Platform (PPP) system for Lenalidomide, Pomalidomide and Thalidomide. This can be best summarised into the three following areas:
Within the training and support team are members with 30 + years pharma experience, much of which was and relates to the delivery of patient safety in the fields of opioid and immune modulatory preparations. Interface with specialist pharmacists and prescribers has been at the forefront of the delivery of training and compliance with Pregnancy Prevention Programmes surrounding their patients.
Our PharmaCare Group specialists have many years’ experience in distributing drugs with teratogenic side effects such as thalidomide, lenalidomide and pomalidomide from a pharmacovigilence perspective and operational perspective. We also have team members with experience in the generic industry with a good understanding of the different supply chain distribution models adopted and work closely with the mainline wholesalers: Alliance Healthcare, Mawdsleys, Phoenix Healthcare and AAH. This will be valuable in bringing such stringent and important requirements to the new licence holders.
Our PharmaCare Group specialists have many years’ experience in distributing drugs with teratogenic side effects such as thalidomide, lenalidomide and pomalidomide from a pharmacovigilence perspective and operational perspective. We also have team members with experience in the generic industry with a good understanding of the different supply chain distribution models adopted. This will be valuable in bringing such stringent and important requirements to the new licence holders.
We work in partnership with a very experienced QPPV who has collected the following experience in connection to the work we do.
- Pharmacovigilance System set-up and development/maintenance of the Pharmacovigilance System Master File (PSMF)
- Ongoing safety surveillance, risk-benefit monitoring, signal detection validation, evaluation and further processing
- Implementation of ISO 90101:2015 Quality Management System aspects
- Risk management, including development of Risk Management Plans (RMPs) and oversight of risk minimisation measures implementation
- Development and submission of Periodic Safety Update Reports (PSURs)
- MHRA ICSR and Submission portals maintenance
- EudraVigilance support, including mandatory ongoing medicinal product data reporting to XEVMPD
- Pharmacovigilance audits and inspections handling
- PV Regulatory Intelligence monitoring and impact assessment
- Regular global literature monitoring
- Timely and quality full-scale processing of Individual Case Safety Reports (ICSRs)
- ICSRs records in E2B and CFR21 compliant Safety Database.
