DOXPUB 13-0001-SOP

Summary:

Describes procedures for reviewing, approving, distributing, tracking, and archiving all US and European promotional materials and advertisements that are distributed to external customers including physicians, patients advocacy groups and medical technicians. Intended to maintain the appropriate ethical, medical, regulatory, and commercial standards for proper internal review of all promotional communications. The process: a) ensures promotional materials comply with all applicable regulatory, legal, medical, company, and promotion practices guidelines, b) ensures promotion is consistent with approved product strategic plans, c) ensures approved material is distributed to internal and external customers in a timely manner.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Flow Chart of Review for Approval Procedures for U.S. Promotion, Flow Chart of Review for Approval Procedures for European Promotion, Promotional Material Review for Approval Form, Designated Signatories, Final Promotional Material Distribution Matrix, Promotional Material and Advertising Document Type Matrix, Advertising and Promotional Material Log

About This Document:

This is not a generic template, it's a 12-page procedure that was actually created and used in the Sales & Marketing operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Sales & Marketing Managers
• Regulatory Affairs Managers
• Executive Management