In the pharmaceutical industry, marketing and promotional materials are subject to rigorous scrutiny to ensure accuracy, compliance with regulations, and ethical promotion of products. Efficient and compliant review and approval of these materials are crucial. This guide provides a comprehensive framework for evaluating pharmaceutical regulatory compliance software vendors specialising in promotional material review systems.
Why a dedicated system is essential:
Manual or basic electronic review processes for promotional materials often struggle to keep pace with regulatory demands and internal compliance policies. Dedicated promotional material review software offers:
- Streamlined workflows: Automates the routing, review, and approval of marketing assets, reducing bottlenecks and accelerating time-to-market.
- Enhanced compliance: Ensures adherence to industry regulations (e.g., FDA OPDP guidelines, PhRMA Code) and internal policies through features like automated checks, version control, and audit trails.
- Improved collaboration: Facilitates efficient collaboration among marketing, legal, medical, and regulatory teams.
- Centralised asset management: Provides a central repository for all promotional materials, ensuring consistency and easy access.
Define your specific needs and requirements:
Before engaging with vendors, define your organisation's specific requirements:- Material types: Identify the types of promotional materials you need to manage (e.g., print ads, digital banners, websites, sales aids, presentations, social media content).
- Stakeholder roles and permissions: Define the different roles involved in the review process (e.g., marketers, legal counsel, medical reviewers, regulatory affairs) and their respective access levels.
- Workflow complexity: Map your existing review and approval workflows, identifying key steps and potential bottlenecks.
- Specific regulatory requirements: identify applicable regulations and guidelines (e.g., FDA 21 CFR Part 11, OPDP guidance, PhRMA code, local advertising codes).
- Global considerations: Consider varying local regulations and language support if operating internationally.
Where does it come from?
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Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit.
What are my payment options?
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- The standard Lorem Ipsum passage, used since the 1500s
- Section 1.10.32 of "de Finibus Bonorum et Malorum", written by Cicero in 45 BC
- At vero eos et accusamus et iusto odio dignissimos ducimus qui blanditiis praesentium
- On the other hand, we denounce with righteous indignation
Where does it come from?
Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur, from a Lorem Ipsum passage, and going through the cites of the word in classical literature, discovered the undoubtable source. Lorem Ipsum comes from sections 1.10.32 and 1.10.33 of "de Finibus Bonorum et Malorum" (The Extremes of Good and Evil) by Cicero, written in 45 BC. This book is a treatise on the theory of ethics, very popular during the Renaissance. The first line of Lorem Ipsum, "Lorem ipsum dolor sit amet..", comes from a line in section 1.10.32.
The standard chunk of Lorem Ipsum used since the 1500s is reproduced below for those interested. Sections 1.10.32 and 1.10.33 from "de Finibus Bonorum et Malorum" by Cicero are also reproduced in their exact original form, accompanied by English versions from the 1914 translation by H. Rackham.
