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Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist

A comprehensive checklist for auditing marketing and promotional materials compliance in pharmaceutical companies to ensure regulatory adherence, ethical practices, and accurate product information dissemination.

Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist
by: audit-now
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About This Checklist

Ensuring compliance in pharmaceutical marketing and promotional activities is crucial for maintaining ethical standards, regulatory adherence, and patient safety. This Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist is an essential tool for evaluating the integrity and regulatory compliance of marketing practices and promotional materials. By systematically assessing content accuracy, fair balance of information, off-label promotion risks, healthcare professional interactions, and regulatory approvals for promotional materials, this checklist helps maintain ethical marketing practices and regulatory compliance. Regular implementation of this comprehensive audit process can significantly reduce risks of regulatory violations, enhance the quality of product information dissemination, and support responsible marketing in the pharmaceutical industry.

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Industry

Pharmaceuticals

Standard

FDA Guidance on Promotional Labeling and Advertising, IFPMA Code of Practice

Workspaces

Research laboratories

Occupations

Regulatory Affairs Specialist
Medical Affairs Professional
Legal Compliance Officer
Marketing Compliance Auditor
Brand Manager

Marketing and Promotional Materials Compliance

(0 / 4)

1
Does the promotional material maintain fair balance?

Select the compliance level regarding fair balance.

To ensure ethical marketing practices.
2
How many interactions with healthcare professionals were documented?

Enter the number of documented interactions.

To evaluate compliance with interaction guidelines.
Min: 0
Target: 0
Max: 100
3
Describe any instances of off-label promotion observed.

Provide details of any off-label promotion.

To identify and mitigate illegal marketing practices.
4
Is the promotional material approved by the regulatory body?

Select the approval status of the promotional materials.

To ensure compliance with FDA regulations and internal policies.
5
Is the product information presented in the digital marketing material accurate?

Select the accuracy level of the product information.

To ensure that all marketing claims are truthful and substantiated.
6
How often are promotional messages sent to healthcare professionals?

Enter the number of promotional messages sent per month.

To assess the frequency of promotional interactions and ensure compliance with guidelines.
Min: 0
Target: 0
Max: 1000
7
Are there any ethical concerns regarding the digital marketing practices?

Detail any ethical concerns noted during the review.

To identify potential ethical violations in marketing strategies.
8
Is the digital marketing content compliant with regulatory standards?

Select the compliance status for digital marketing content.

To ensure that all digital marketing materials meet regulatory requirements.
9
Was the promotional material verified for regulatory compliance?

Select the verification status for regulatory compliance.

To ensure that all promotional activities adhere to applicable regulations.
10
How many revisions were required for the promotional materials?

Enter the total number of revisions needed.

To track the effectiveness and thoroughness of the promotional review process.
Min: 0
Target: 0
Max: 50
11
Provide a summary of feedback received during the promotional review.

Summarize the key feedback points from the review process.

To document insights and areas for improvement identified in the review.
Write something awesome...
12
Is the promotional review process complete for all materials?

Select the completeness status of the promotional review process.

To ensure that all promotional materials undergo a thorough review before use.
13
Did the interaction comply with company guidelines for healthcare professional engagement?

Select the compliance status of the interaction.

To ensure adherence to established policies and ethical standards.
14
How many attendees were present during the interaction?

Enter the total number of attendees.

To evaluate the scale of the interaction and ensure compliance with guidelines.
Min: 1
Target: 1
Max: 10
15
What was the purpose of the interaction with the healthcare professional?

Describe the purpose of the interaction.

To assess the intent and appropriateness of the interactions.
16
Is there proper documentation for all interactions with healthcare professionals?

Select the documentation status of interactions.

To ensure that all communications are logged and compliant with industry standards.
17
Does the promotional material align with ethical marketing practices?

Select the ethical alignment status of the promotional material.

To ensure that marketing materials adhere to ethical standards.
18
How many claims are made in the promotional material?

Enter the total number of claims made.

To evaluate the density of claims and their compliance with regulations.
Min: 0
Target: 0
Max: 20
19
Provide any notes regarding the accuracy of the content.

Detail any accuracy notes related to the promotional content.

To document any discrepancies or concerns raised during the review.
Write something awesome...
20
Has the promotional material undergone a complete content review?

Select the completion status of the content review.

To ensure that all materials are thoroughly reviewed before distribution.

FAQs

These audits should be conducted at least bi-annually, with more frequent reviews for new product launches or significant marketing campaign changes. Additionally, spot checks should be performed regularly on ongoing promotional activities.

This checklist covers review of promotional material content, assessment of fair balance in product information, evaluation of off-label promotion risks, compliance in healthcare professional interactions, social media and digital marketing practices, and regulatory approval processes for promotional materials.

These audits are typically conducted by regulatory affairs specialists, medical affairs professionals, legal compliance officers, or qualified marketing compliance auditors with expertise in pharmaceutical marketing regulations.

The checklist ensures that all marketing and promotional activities adhere to regulatory guidelines, including accurate product claims, proper disclosure of risk information, and compliance with regulations like the FDA's fair balance requirements and global codes of practice.

If non-compliant materials or practices are identified, actions should include immediate withdrawal or correction of the materials, investigation of the approval process breakdown, retraining of relevant personnel, review of similar materials for potential issues, and implementation of enhanced review processes. All actions must be documented and reported to management.

Benefits

Ensures compliance with regulatory guidelines for pharmaceutical marketing and promotion

Reduces risks of regulatory violations and potential legal liabilities

Improves the accuracy and fair balance of product information in promotional materials

Enhances ethical standards in interactions with healthcare professionals

Facilitates consistent and compliant global marketing practices