Risk Evaluation & Mitigation Strategy
Expert REMS Consulting & Innovative Patient Safety
Experienced, Professional, Expert in REMS
With over 20 years of Risk Management and REMS experience in the Pharmaceutical Industry, Sherice Mills provides consulting, innovative patient safety and risk management tools to optimize a marketed product’s safety profile. She provides expert skills and knowledge aimed to address patient safety through innovative risk management solutions and close parternship with regulatory authorities.
Services
Risk Evaluation & Mitigation Strategy (REMS)
REMS Document Development
Risk Management Strategies
Training
Consulting
System & Staff Alignment
Vendor Support
Negotiation Strategies
Meet Sherice Mills
Sherice Mills, CEO and President of ADROIT Risk Management, LLC. With over 20 years of experience in patient safety and risk management, her leadership in the Risk Evaluation and Mitigation Strategy (REMS) industry is well established. Patient safety has been the driving force behind Sherice’s passion for risk management in pharmaceuticals. ADROIT is specifically poised to support design, development and implementation of FDA required REMS, regardless of complexity. The team at ADROIT diligently identify, assess, and develop tools aimed to mitigate any identified risks, providing the necessary balance between risk and benefit for patients. A frequent speaker at industry events and recognized subject matter expert, Sherice’s experience is unmatched in navigating and demystifying the nuances of REMS. She has worked very closely with FDA since the inception of REMS in 2007 and has maintained significantly important relationships with the Agency in this space. Supporting both industry and regulators with innovative solutions for patient safety is the main focus for ADROIT Risk Management.
If your organization is in need of consulting support with your risk management projects, full fledge REMS development, or general patient safety tools, Adroit Risk Management is the best option available and should absolutely be your first choice as a partner.
Here are just a few of the services that Adroit Risk Management offers:
- Development and support of Risk Evaluation and Mitigation Strategy (REMS)
- FDA Negotiation Strategies
- Regulatory Inspection readiness
- Organizational alignment for inclusion of REMS
- Risk Management Strategies
- Development of focused education and training
- Document Development
- System & Staff Alignment
- Vendor Support
We can help you with all aspects of risk management, from identifying and assessing risks to implementing controls and monitoring your risk management process. ADROIT Risk Management can also provide you with education and training on risk management so that you can make informed decisions about your business’s risk profile.
If you are interested in learning more about how ADROIT Risk Management, LLC can help you with your risk management needs, please visit our contact page and complete the contact form for prompt response to your request. ADROIT can support any of your patient safety needs!
You can also connect with Sherice on LinkedIn here.
