The Critical Role of the Training Manager

As a pharmaceutical sales training manager, you are the project owner responsible for the development and submission of training materials to the Medical, Legal, and Regulatory (MLR) review team. Your role is crucial in ensuring that the training materials align with commercial objectives and meet training needs. This involves close collaboration with MLR reviewers to ensure compliance with all guidelines and regulations.

Your responsibilities include overseeing the creation of materials both in house and through external agencies, and ensuring that these materials are thoroughly vetted before submission. This proactive approach helps to preempt any potential compliance issues and streamlines the review process.

 

Understanding the Responsibilities of MLR Review Teams

The MLR review teams are composed of experts in the fields of medicine, law, and regulatory affairs. Each member has specific responsibilities that contribute to the overall compliance and effectiveness of the training materials.

The Medical Reviewer ensures medical and scientific accuracy, checks for appropriate references, and verifies that the reference annotations support the claims and messages presented. The Legal Reviewer ensures that all materials comply with federal and state laws, while the Regulatory Reviewer ensures compliance with FDA regulations and policies, providing regulatory interpretations when necessary.

Effective Collaboration with Medical Reviewers

Working closely with Medical Reviewers is crucial for ensuring the scientific integrity of your training materials. They verify the accuracy of medical content and the validity of references used. This collaboration can help prevent potential miscommunications and ensure that all claims are properly supported.

It’s beneficial to engage with Medical Reviewers early in the project. Scheduling a concept review during the design phase can help address any compliance concerns from the outset, making the subsequent review process smoother and more efficient.

Navigating Legal and Regulatory Compliance

Ensuring that your training materials meet legal and regulatory standards is essential for maintaining compliance and avoiding potential penalties. The Legal Reviewer is responsible for ensuring that all content complies with relevant laws, while the Regulatory Reviewer ensures adherence to FDA regulations.

To navigate this complex landscape, it’s important to provide clear context for the training and its objectives. Being prepared to answer questions and suggest compliant alternatives when necessary can foster a collaborative environment and facilitate a smoother review process.

 

Key Do’s and Don’ts for a Smooth MLR Review Process

Here are some key do’s and don’ts to keep in mind for a successful MLR review process.

Do:

1. Schedule a concept review during the design phase if you are unsure about compliance.
2. Before submission, quality check training assets thoroughly to ensure they follow MLR guidelines.
3. Review comments before the MLR meeting and come prepared with revision suggestions.
4. Provide context for the training and its learning objectives at the start of a meeting.
5. Take responsibility for the content during an MLR meeting; answer questions yourself and involve agency partners when needed.
6. Respect the reviewers’ roles as collaborators in creating compliant training.
7. Suggest compliant alternatives if you disagree with a requested revision.
8. Thoroughly review content to ensure all reviewer comments are addressed when resubmitting for approval.

Don’t:

1. Wait until a training asset is complete before gaining buy-in from reviewers.
2. Rely solely on your vendor to follow MLR guidelines without performing a quality check.
3. Wait until the MLR meeting to read and consider each comment.
4. Allow MLR reviewers to make their own assumptions about the training’s purpose and usage.
5. Mute yourself during an MLR meeting and rely entirely on your agency partner to answer questions.
6. Create a hostile relationship with reviewers by arguing or dismissing their concerns.
7. Blindly accept all comments without considering whether they diminish the training’s value.
8. Assume your agency partner has completed all MLR revisions without reviewing the content before resubmission.

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