REMS & RMP Support

A REMS (Risk Evaluation and Mitigation Strategy) or RMP (Risk Management Plan) is a critical safety program mandated by regulatory authorities to manage the risks associated with specific medications.

Customer service professional in a contact center wearing headset asking a coworker-a-question

These programs ensure that patient access to necessary drugs while minimizing potential harm. REMS or RMP focuses on preventing, monitoring, and managing a specific serious risk by informing, educating, and reinforcing actions to reduce the likelihood and severity of adverse events. These programs reinforce safe medication use behaviours and educate stakeholders on essential precautions. ProPharma's Contact Center Operations support REMS and RMP programs by serving as a central point of contact for patients and healthcare providers. We offer a globally accesssible REMS/RMP services in, over 40 languages, adapting to local working hours and days. Our offerings include scalability, flexibility, and customizable options to support an expanding REMS portfolio. By partnering closely with our clients, we share best practices driving both innovation and efficiency. We are committed to service advancements through the use of technologies such as workforce management tools, digital communication channels (including chatbots and live chat), customer satisfaction surveys after calls, and automated line testing.

Medical Information icon

Inquiry Support

Inquiry Support

Document search icon

Product Access and Information

Product Access and Information

Decentralized Clinical Trials icon

Adverse Event (AE) Management

Adverse Event (AE) Management

Medical writing icon

Training and Education

Training and Education

Inquiry Support

  • Global Availability: ProPharma operates globally, offering support in all supported languages and aligning with local time zones.
  • Multi-Channel Platforms: Provides assistance across various regions through phone, chat, email and other communication channels.
  • Expert Management: Handles specific inquiries from healthcare providers and patients regarding risk management and minimization measures.
  • Informed Decision-Making: Facilitates informed decision-making for healthcare providers.
  • Comprehensive Resources: Maintains a repository of response documents and a comprehensive database of all submitted inquiries.
  • Regular Reporting: Ensures consistent and detailed reporting.
  • Compliance and Cultural Sensitivity: Complies with local legislation and adheres to local customs and cultures.
Confident worker woman looking at camera

Product Access and Information

  • Critical Product Access Information: Provides essential information to ensure access to critical products.
  • Efficient Dissemination: Streamlines the distribution of RMP materials, both electronically and in hard copy.
  • Pharmacy and Program Locator: Help locate pharmacies and programs that support access to REMS-required medications for patients.
  • Patient Support: We offer assistance to patients facing financial or access barriers.
Several business professionals having fun at a business meeting

Adverse Event (AE) Management

  • Adverse Event Identification and Intake: Our experienced team efficiently identifies and intakes adverse events. Specific REMS questionnaire can be completed at intake.
  • Rapid Response: Quickly Identify and respond to safety concerns notifying these immediately to the client.
  • Accurate Triage: Ensure precise triage and effective communication with relevant teams.
  • Expedited Reporting: Adheres to accelerated  AE reporting timelines.
  • Post-AE Follow-Up: Conducts thorough follow-up after adverse events in the local language either in writing or via telephone.
Business professionals smiling at a desk reviewing data

Training and Education

  • Educational Material Provision: Distributes educational materials to patients, including brochures, guides, and alert cards.
  • Up-to-Date Information: Keeps healthcare providers and patients informed on the latest risk management strategies and guidelines.
  • Compliance Reminders: Provides reminders and information on best practices to ensure compliance.
  • Certification Verification: Evaluates and verifies healthcare providers’ certification in REMS or RMP.
  • Educational Session Support: Facilitates registration and follow-up for educational sessions.
Row of professionals working at a conference table

Our REMS and RMP Experts

  • Valerie Huh Bio Photo

    Valerie Huh

    Director, Global Innovation and Implementation

    View Bio

  • Eric Brandon Bio Photo

    Eric Brandon

    Director, Patient Services & Contact Center Operations

    View Bio

  • Ana Ming Bio Photo

    Ana Ming

    Senior Global Innovation and Implementation Manager

    View Bio

Valerie Huh brings over 20 years of experience in the pharmaceutical and healthcare industries, with expertise in global operations and process improvements. She holds a Doctor of Pharmacy (Pharm.D.), a degree in Chemistry, and an MBA with a certificate in business analytics. In her current role, she leads innovation and technology enablement in Medical Information and supports business expansions, driving forward strategic initiatives to enhance service quality and operational efficiency.

Eric has spent 30+ years in the pharmaceutical industry with the last 12 years striving to make a difference in Patient Services on the manufacturer side, as a consultant, and as a leader on the supplier side. As Director, Patient Services & Contact Center Operations he leads the strategy and oversight for global and regional Patient Support Programs (PSPs), Commercial Services, Clinical Trial Support, and other Global contact center-based programs.

He has a great passion for supporting patients wherever they are in their clinical trial or treatment journey. Eric inspires his team to focus on the patient and their specific needs to ensure they get the right support throughout their treatment journey, including insurance benefits verification, financial support, device training and support, concierge travel assistance and other innovative services. More importantly, we are here to provide the right level of professional resources to support patients through their treatment journey to ensure their safety and improve their health.

Ana Ming is a highly skilled pharmacist based in Australia, with 12+ years of experience in the pharmaceutical services and healthcare industries. Currently at ProPharma, she brings expertise in medical information management, patient care, and regulatory compliance. Additionally, Ana is a certified Justice of the Peace (JP), combining her healthcare experience with a commitment to community service and ethical leadership. Her collaborative approach, coupled with a focus on innovative solutions, makes her a valuable asset in optimizing patient outcomes and advancing pharmaceutical practices.

REMS & RMP Contact Center Support

Ensure safe medication practices and minimize risks with ProPharma’s REMS/RMP support services. Our globally accessible solutions provide expert assistance to patients and healthcare providers in over 40 languages, enhancing risk management through informed decisions and reliable communication channels.

News & Insights

WHO Issues Guidance on Antibiotic Pollution Control

December 19, 2024

WHO Issues Guidance on Antibiotic Pollution Control

WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

December 18, 2024

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.

Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

December 17, 2024

Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

Explore the importance of market access and reimbursement strategies for medical devices and in vitro diagnostics (IVDs) in Europe. Learn how early planning and the new European HTAR can enhance the...

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

Previous Post Arrow Next Post Arrow
ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Previous Award Arrow Next Award Arrow
WHO Issues Guidance on Antibiotic Pollution Control

December 19, 2024

WHO Issues Guidance on Antibiotic Pollution Control

WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

December 18, 2024

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.

Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

December 17, 2024

Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

Explore the importance of market access and reimbursement strategies for medical devices and in vitro diagnostics (IVDs) in Europe. Learn how early planning and the new European HTAR can enhance the...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow