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What are the best practices for communicating with stakeholders about FDA risk management plan updates?

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A risk management plan (RMP) is a document that outlines how a medical product developer will identify, assess, and mitigate potential risks associated with the use of their product. The Food and Drug Administration (FDA) requires RMPs for certain products that have significant safety concerns or require additional measures to ensure their safe and effective use. In this article, we will discuss some of the best practices for communicating with stakeholders about FDA RMP updates.

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1 Why communicate RMP updates?

RMPs are not static documents. They need to be updated regularly to reflect new data, changes in the product's label or indications, or feedback from the FDA or other regulatory agencies. Communicating RMP updates to stakeholders, such as health care providers, patients, and payers, is essential to ensure that they are aware of the latest information and recommendations regarding the product's benefits and risks. Communicating RMP updates can also help to build trust, transparency, and collaboration among stakeholders and foster a culture of safety and quality.

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Ruth Ola, MSc, PMP?, CMQ/OE

Expert in Quality Management System & Organizational Excellence
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I definitely agree that RMP must be a living document that should be reviewed to evaluate both internal and external issues that could impact the context of the organization.

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Mark Meelhuysen, MBA, EIT

Capital Project Manager
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One of the best ways to communicate with stakeholders is to evaluate the current state and the new upcoming state regarding a risk and communicating such that each stakeholder audience understands how they will be affected. When stakeholders understand how they'll be impacted, they often can tolerate and accept the changes better, reducing defensiveness, miscommunication, and reducing the organizational inertia in implementing the change.

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2 Who are the key stakeholders for RMP updates?

The key stakeholders for RMP updates may vary depending on the product, the target population, and the risks involved. However, some of the common stakeholders include the FDA and other regulatory agencies that oversee the product's approval and post-marketing surveillance, health care providers who prescribe, dispense, or administer the product to patients, patients who use the product or participate in clinical trials or registries, payers who reimburse the product or provide coverage for patients, advocacy groups or professional associations that represent the interests of patients or health care providers, and the media or public health authorities that disseminate information or guidance about the product.

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Elizabeth Odera, PhD PMP?,HSC, Medal of Honor, Hall of Fame

Tennis Professional | Senior Project Manager
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This is well described, however much of the medical research institutions (Research labs) and CRO (who represent the Sponsor) are involved in drug development and would need to be included.

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Ruth Ola, MSc, PMP?, CMQ/OE

Expert in Quality Management System & Organizational Excellence
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It is important to clearly identify all relevant interested parties. This has to be fairly detailed to ensure appropriate stakeholders are well informed.

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3 How to communicate RMP updates effectively?

When communicating RMP updates to stakeholders, it is important to plan ahead and identify the goals, objectives, and messages of the communication. Additionally, the communication should be tailored to the specific needs, preferences, and expectations of each stakeholder group. Clear, concise, and consistent language should be used, avoiding jargon, acronyms, or technical terms that may confuse or mislead the audience. Accurate, relevant, and timely information and evidence should be provided to support the claims and recommendations. The benefits and risks of the product should be highlighted and explained, and multiple channels and formats should be used to deliver the communication. Feedback and input from stakeholders should be solicited and addressed, and the impact and outcomes of the communication should be monitored and evaluated.

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Ruth Ola, MSc, PMP?, CMQ/OE

Expert in Quality Management System & Organizational Excellence
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There is need to develop a communication plan to prioritize what each stakeholder need to know and through what channel. A communication plan will help keep appropriate stakeholder informed.

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Elizabeth Odera, PhD PMP?,HSC, Medal of Honor, Hall of Fame

Tennis Professional | Senior Project Manager
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I recognize the need to tailor make the information to suit different audiences, however this potentially raises new concerns as there may be a tendency to avoid sharing critical information.

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4 What are the common challenges and barriers to communicating RMP updates?

Communicating RMP updates to stakeholders can be a complex and challenging task for a variety of reasons. There is a lack of a standardized or harmonized framework for RMP communication across different regions or jurisdictions, and the quality, quantity, and frequency of RMP updates from different product developers or sponsors can vary. Additionally, some stakeholders may have limited resources, time, or motivation to access, understand, or act on the RMP updates. Furthermore, there is a potential for misinterpretation, confusion, or misinformation about the RMP updates due to conflicting or contradictory sources, biases, or agendas. Lastly, there is a risk of legal, ethical, or reputational implications or consequences of RMP communication for the product developer or sponsor, the FDA, or the stakeholders.

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Elizabeth Odera, PhD PMP?,HSC, Medal of Honor, Hall of Fame

Tennis Professional | Senior Project Manager
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There had been in place standardized systems and training on Risk Management, such as RPMP certification courses, only a limited number of project management professionals have taken it seriously, this coupled with the need to provide successful results can cause disaster to the end user, who is the patient.

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5 How to overcome the challenges and barriers to communicating RMP updates?

To effectively communicate RMP updates, product developers or sponsors must take a proactive, collaborative, and transparent approach. This can be achieved by engaging and involving stakeholders early and throughout the RMP development and implementation process, aligning and coordinating RMP communication with the FDA and other regulatory agencies, conducting a stakeholder analysis and a communication needs assessment, developing and implementing a comprehensive and flexible RMP communication plan, leveraging existing or established networks, platforms, or partnerships, and evaluating and measuring the effectiveness and impact of RMP communication. Doing so will help to identify gaps, opportunities, and best practices for RMP communication, facilitate and enhance RMP communication and dissemination, and use feedback and data to improve and refine the communication.

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Elizabeth Odera, PhD PMP?,HSC, Medal of Honor, Hall of Fame

Tennis Professional | Senior Project Manager
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It’s import to include a lessons learned system in order to avoid previous pitfalls, when communicating with stakeholders. A pre-determined regular review of the risks in a project or process; including new risks and retiring old is important.

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What are the best practices for communicating with stakeholders about FDA risk management plan updates?

1

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3

4

5

1 Why communicate RMP updates?

2 Who are the key stakeholders for RMP updates?

3 How to communicate RMP updates effectively?

4 What are the common challenges and barriers to communicating RMP updates?

5 How to overcome the challenges and barriers to communicating RMP updates?

Quality Management

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What are the best practices for communicating with stakeholders about FDA risk management plan updates?

1

2

3

4

5

1 Why communicate RMP updates?

2 Who are the key stakeholders for RMP updates?

3 How to communicate RMP updates effectively?

4 What are the common challenges and barriers to communicating RMP updates?

5 How to overcome the challenges and barriers to communicating RMP updates?

Quality Management

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