Instructor :
Charles H. Paul

Webinar ID:
13123

The importance of Post-Market Surveillance (PMS) has skyrocketed as global regulatory agencies, including the FDA and European Medical Device Regulation (EU MDR), emphasize the real-world safety and performance of medical devices and other regulated products.

Traditional focus on pre-market approval is no longer enough—real-world use often uncovers risks and performance issues that must be addressed proactively.

Why PMS Matters Now More Than Ever:

• • Prevent costly recalls and penalties by identifying potential risks early.
  • Enhance patient safety and product reliability through data-driven insights.
  • Meet stringent regulatory demands with comprehensive PMS plans.

This 90-minute webinar will teach you how to design and implement a robust PMS framework to:

• • Monitor real-world product performance using advanced tools and technologies.
  • Collect and analyze data from adverse event reports, customer feedback, and registries.
  • Leverage PMS as a strategic tool to drive innovation, improve product performance, and foster stakeholder trust.

Participants will gain actionable insights into:

• • Navigating complex regulatory requirements like the EU MDR and FDA updates.
  • Implementing effective data monitoring and trend analysis systems.
  • Turning PMS into a driver of business sustainability and competitive advantage.

This training is designed for professionals in quality assurance, regulatory affairs, product development, and risk management who are looking to stay ahead of regulatory expectations while delivering safer, more effective products.

Don’t miss this opportunity to future-proof your PMS program and safeguard your business and patients.

Register now to unlock the tools, strategies, and best practices for proactive compliance and market success.

Enroll Now!

The importance of Post-Market Surveillance (PMS) has skyrocketed as global regulatory agencies, including the FDA and European Medical Device Regulation (EU MDR), emphasize the real-world safety and performance of medical devices and other regulated products.

Traditional focus on pre-market approval is no longer enough—real-world use often uncovers risks and performance issues that must be addressed proactively.

Why PMS Matters Now More Than Ever:

• • Prevent costly recalls and penalties by identifying potential risks early.
  • Enhance patient safety and product reliability through data-driven insights.
  • Meet stringent regulatory demands with comprehensive PMS plans.

This 90-minute webinar will teach you how to design and implement a robust PMS framework to:

• • Monitor real-world product performance using advanced tools and technologies.
  • Collect and analyze data from adverse event reports, customer feedback, and registries.
  • Leverage PMS as a strategic tool to drive innovation, improve product performance, and foster stakeholder trust.

Participants will gain actionable insights into:

• • Navigating complex regulatory requirements like the EU MDR and FDA updates.
  • Implementing effective data monitoring and trend analysis systems.
  • Turning PMS into a driver of business sustainability and competitive advantage.

This training is designed for professionals in quality assurance, regulatory affairs, product development, and risk management who are looking to stay ahead of regulatory expectations while delivering safer, more effective products.

Don’t miss this opportunity to future-proof your PMS program and safeguard your business and patients.

Register now to unlock the tools, strategies, and best practices for proactive compliance and market success.

Enroll Now!

In today’s highly regulated and competitive environment, life science professionals are under immense pressure to ensure safety, efficacy, and regulatory compliance for medical devices, pharmaceuticals, and related products.

The growing regulatory scrutiny and rapidly evolving global standards make it imperative to stay ahead of post-market surveillance (PMS) requirements.

This training is specifically designed to help professionals like you overcome the challenges of implementing and managing robust PMS systems while addressing key pain points in your role.

Here’s Why You Can’t Miss This Webinar:

• • Stay ahead of evolving regulations: Gain a clear understanding of critical PMS requirements, including updates from FDA and EU MDR.
  • Safeguard your organization’s reputation: Learn strategies to identify and mitigate risks early, preventing costly recalls and adverse events.
  • Enhance your skills and expertise: Master techniques for collecting and analyzing data from complaints, adverse event reports, and registries to improve product safety and performance.
  • Drive career growth and professional impact: Demonstrate leadership by implementing best practices that strengthen your organization’s quality management systems.
  • Improve patient outcomes and trust: Ensure your products meet the highest safety and efficacy standards, building confidence among stakeholders.

Make the choice to stay informed and proactive. This webinar will equip you with actionable insights and proven strategies to future-proof your PMS processes, protect patient safety, and maintain your competitive edge.

Register now and take the next step in your professional growth.

In today’s highly regulated and competitive environment, life science professionals are under immense pressure to ensure safety, efficacy, and regulatory compliance for medical devices, pharmaceuticals, and related products.

The growing regulatory scrutiny and rapidly evolving global standards make it imperative to stay ahead of post-market surveillance (PMS) requirements.

This training is specifically designed to help professionals like you overcome the challenges of implementing and managing robust PMS systems while addressing key pain points in your role.

Here’s Why You Can’t Miss This Webinar:

• • Stay ahead of evolving regulations: Gain a clear understanding of critical PMS requirements, including updates from FDA and EU MDR.
  • Safeguard your organization’s reputation: Learn strategies to identify and mitigate risks early, preventing costly recalls and adverse events.
  • Enhance your skills and expertise: Master techniques for collecting and analyzing data from complaints, adverse event reports, and registries to improve product safety and performance.
  • Drive career growth and professional impact: Demonstrate leadership by implementing best practices that strengthen your organization’s quality management systems.
  • Improve patient outcomes and trust: Ensure your products meet the highest safety and efficacy standards, building confidence among stakeholders.

Make the choice to stay informed and proactive. This webinar will equip you with actionable insights and proven strategies to future-proof your PMS processes, protect patient safety, and maintain your competitive edge.

Register now and take the next step in your professional growth.

1. Introduction to Post-Market Surveillance

• • Importance of PMS in regulatory compliance and patient safety.
  • Overview of global regulatory landscapes driving PMS (e.g., FDA, EU MDR).
  • Key Objectives of the webinar and what participants will achieve.

2. Core Concepts of Post-Market Surveillance

• • Definition and Purpose of PMS in the product lifecycle.
  • Roles and responsibilities of key stakeholders in PMS processes.
  • Seamless integration of PMS into the product lifecycle for improved outcomes.

3. Regulatory Requirements for Post-Market Surveillance

• • Comprehensive overview of regulatory frameworks (FDA, EU MDR, and other global standards).
  • PMS reporting requirements and expectations.
  • Understanding differences and overlaps in global regulations to ensure compliance.

4. Establishing a Robust PMS System

• • Essential components of a successful PMS plan, including:
    • Data Collection and monitoring techniques.
    • Integration of risk management practices.
    • Feedback loops for continuous product improvement.
  • PMS Documentation and audit readiness strategies to maintain compliance.

5. Tools and Techniques for Effective PMS

• • Identification of data sources for PMS (complaints, adverse events, registry data, etc.).
  • Overview of software tools and technologies supporting PMS activities.
  • Advanced methods for trend analysis and signal detection to preempt risks.

6. Common Challenges and Practical Solutions

• • Strategies for managing diverse data sources and ensuring data quality.
  • Best practices for cross-functional collaboration to streamline PMS activities.
  • Guidance on staying compliant amidst changing regulations and evolving standards.

7. Best Practices for Staying Ahead of Regulatory Expectations

• • Proactive approaches to risk management and continuous improvement.
  • Leveraging PMS insights for innovation and maintaining market competitiveness.
  • Effective strategies for communicating with regulatory bodies and building trust.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

1. Introduction to Post-Market Surveillance

• • Importance of PMS in regulatory compliance and patient safety.
  • Overview of global regulatory landscapes driving PMS (e.g., FDA, EU MDR).
  • Key Objectives of the webinar and what participants will achieve.

2. Core Concepts of Post-Market Surveillance

• • Definition and Purpose of PMS in the product lifecycle.
  • Roles and responsibilities of key stakeholders in PMS processes.
  • Seamless integration of PMS into the product lifecycle for improved outcomes.

3. Regulatory Requirements for Post-Market Surveillance

• • Comprehensive overview of regulatory frameworks (FDA, EU MDR, and other global standards).
  • PMS reporting requirements and expectations.
  • Understanding differences and overlaps in global regulations to ensure compliance.

4. Establishing a Robust PMS System

• • Essential components of a successful PMS plan, including:
    • Data Collection and monitoring techniques.
    • Integration of risk management practices.
    • Feedback loops for continuous product improvement.
  • PMS Documentation and audit readiness strategies to maintain compliance.

5. Tools and Techniques for Effective PMS

• • Identification of data sources for PMS (complaints, adverse events, registry data, etc.).
  • Overview of software tools and technologies supporting PMS activities.
  • Advanced methods for trend analysis and signal detection to preempt risks.

6. Common Challenges and Practical Solutions

• • Strategies for managing diverse data sources and ensuring data quality.
  • Best practices for cross-functional collaboration to streamline PMS activities.
  • Guidance on staying compliant amidst changing regulations and evolving standards.

7. Best Practices for Staying Ahead of Regulatory Expectations

• • Proactive approaches to risk management and continuous improvement.
  • Leveraging PMS insights for innovation and maintaining market competitiveness.
  • Effective strategies for communicating with regulatory bodies and building trust.

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

The following benefits from watching this. Even better when done as a group!

• • Quality Managers Seeking to Strengthen Compliance and Improve Product Safety
  • Regulatory Affairs Professionals Struggling to Navigate Complex Global Requirements
  • Product Development Teams Looking to Enhance Product Performance Post-Market
  • Risk Management Specialists Focused on Proactively Addressing Potential Issues
  • Operations Leaders Committed to Aligning PMS Processes with Regulatory Standards
  • Innovation Teams Seeking Insights for Market Competitiveness and Product Evolution
  • Training Managers Tasked with Equipping Teams for Regulatory Compliance
  • HR Professionals Looking to Build Competency in Regulatory and Quality Functions
  • Senior Leaders Focused on Safeguarding Organizational Reputation and Reducing Risks

The following benefits from watching this. Even better when done as a group!

• • Quality Managers Seeking to Strengthen Compliance and Improve Product Safety
  • Regulatory Affairs Professionals Struggling to Navigate Complex Global Requirements
  • Product Development Teams Looking to Enhance Product Performance Post-Market
  • Risk Management Specialists Focused on Proactively Addressing Potential Issues
  • Operations Leaders Committed to Aligning PMS Processes with Regulatory Standards
  • Innovation Teams Seeking Insights for Market Competitiveness and Product Evolution
  • Training Managers Tasked with Equipping Teams for Regulatory Compliance
  • HR Professionals Looking to Build Competency in Regulatory and Quality Functions
  • Senior Leaders Focused on Safeguarding Organizational Reputation and Reducing Risks