UBC’s industry-leading risk management and epidemiology experts help clients appropriately balance the benefits and risks of innovative medicines and medical technology.
We help clients assess product safety, develop appropriate risk minimization action plans and implement a broad range of product safety strategies and programs.
Clients call on UBC to help with:
- Risk minimization action plans and risk evaluation and mitigation strategies
- Large streamlined safety studies
- Registry design and implementation
- Data safety monitoring board services
- Regulatory strategy and submissions
- Risk-benefit modeling
- Custom and rapid literature reviews
- Systematic literature reviews and meta-analysis
- Epidemiology studies and patient database analysis
- Risk management consulting and program evaluations
- Epidemiologic risk assessment
- Risk management intervention including performance linked access
- Pharmacovigilance plans
With these tools, we can help sponsors:
- Identify areas that require risk management
- Design clinical programs to meet regulatory requirements
- Design and implement disease and product registries to meet regulatory requirements and address commercial objectives
- Examine real-world use of drugs and associated outcomes
- Understand drug safety issues and individual risk factors at the patient level
- Prepare safety reports and manuscripts for regulatory, product marketing and medical communications
Guided by our epidemiology and risk management leadership, UBC scientists have designed and implemented more than thirty (30) risk management programs (RiskMAPs) and risk evaluation and mitigation strategies (REMs) that focus on reducing product risk and preserving product benefits for pharmaceutical, biotechnology and device manufacturers.
The world-class scientists supervising the development of this training include experts with extensive regulatory and FDA experience: Gerald Faich, MD, MPH served in senior management positions at FDA and Annette Stemhagen, DrPH, FISPE was the first industry representative to the FDA Drug Safety and Risk Management Advisory Committee. Sponsors often contact UBC specifically to speak with Dr. Faich and Dr. Stemhagen.
For additional background on risk management, click on the links below to download the three FDA Risk Management Guidance documents and the text of the FDA Amendments Act. In addition, the European Guideline on Risk Management is also available at this site.
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Risk Management FDA Amendments Act of 2007 and Products Deemed to Have REMS including:
- Title IX: Enhanced Authorities Regarding Postmarket Safety of Drugs
- Subtitle A: Postmarket Studies and Surveillance
- Subtitle B: Other Provisions to Ensure Drug Safety and Surveillance
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Risk Management: FDA Guidance for the Industry including:
- FDA Guidance on Pre-marketing Risk Assessment
- Development and Use of Risk Minimization Action Plans (RiskMAPs)
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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Risk Management European Medicines Agency including:
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Guideline on Risk Management Systems for Medical Products for Human Use
- Annex A: Epidemiological Methods for Post-authorization Safety Studies
- Annex B: Methods for Risk Minimization
- Annex C: Template for Risk Management Plan
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Guideline on Risk Management Systems for Medical Products for Human Use