Risk Management & Pharmacovigilance Services
1. Risk Management
With recent legislative changes and increased regulatory focus on product safety and benefit-risk balance, we at BethAri have the experience, approach and infrastructure to help our clients mitigate risk. We can design, develop and implement a comprehensive risk management program to address specific product safety concerns and ensure appropriate product use. Our risk management services include a systematic approach designed to help increase benefits and reduce therapeutics risks:
- Risk Identification & Assessment
- Risk Communication
- Evaluation of effectiveness of risk reduction interventions
- Re–evaluation or modification of interventional approaches
- Total analysis of a Risk Evaluation & Mitigation Strategies (REMS)
Risk evaluation and mitigation strategies (REMS) are designed and implemented during the commercialisation of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks. The licensing authorities / agencies determine if a REMS program is necessary and BethAri has a range of capabilities and extensive experience with which to support REMS programs for clients.
For any company, ensuring the safety of its medicines is a critical priority. At BethAri we understand the challenges associated with this activity and the specialist expertise required to overcome them.
We at BethAri offer a comprehensive and flexible suite of pharmacovigilance and safety monitoring services from early development support through post-approval initiatives. Our pharmacovigilance experts specialize in managing clinical trial AEs and SAEs, including initial receipt, case processing and follow-up, medical review, and closure.
Our experienced PVG specialists will help you in evolving your safety monitoring and safety reporting practices in response to changing regulatory standards, and thereby allowing you to evaluate and manage risk over the lifetime of your product.
Whether you need an interim solution to deliver immediate operational assistance to meet a short-term need or a more strategic review of a wider drug safety issue, we are positioned to help you respond to increasing regulatory pressures and help you keep control of your drug safety and development programs.
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3. Other services
We also offer further services in Risk Management and Pharmacovigilance services. These include training and audit of pharmacovigilance systems. With considerable expertise we are is ideally suited to provide training in:
- General Introduction to Pharmacovigilance
- National & International Pharmacovigilance Regulations & Initiatives
- Drug Safety in Clinical Trials
- Post-Marketing Pharmacovigilance
- Inspection Readiness for Pharmacovigilance
- Other bespoke & company specific Pharmacovigilance Training modules (including ICSR management, SUSARs & Clinical Trial reporting, SOPs, literature search management)
- We can provide comprehensive and detailed Audits, Inspections & Compliance Management including;
- Independent Audit of Pharmacovigilance Systems
- Inspection Preparation & Support
- Pharmacovigilance Service Provider Audit / Review
- Implementation of Metrics & Trending (Compliance)