Increasing brand awareness, maximizing sales and turbo-charging your return on investment (ROI) are the driving forces behind advertising and other promotional materials for pharmaceutical products. And yet you face many challenges – ranging from differing and conflicting regulations governing promotional material in national markets through to internal bottlenecks in your promotional review processes.
What is the promotional review process?
The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market. By nature, it requires skill sets ranging from marketing – where material is generally drafted – through to the medical, legal and regulatory (MLR) expertise brought together in a cross-functional Promotion Advertising Review Committee (PARC).
Are your promotional review processes watertight?
Like labeling and packaging, advertising and promotion of medicines is subject to strict regulations by the US Food and Drug Administration (FDA) and European Union (EU), as well national regulations.
[1, 2] Yet the sheer range of promotional material types and possible promotional media creates a challenge for regulators in terms of providing comprehensive guidelines. The risks of non-compliance include high costs, delayed product launches, damage to brand reputation, safety issues and even litigation. This makes it all the more important to have watertight promotional review processes in place.
Preparing for the promotional review process
The speed of turnarounds will depend on the quality of your people and processes in the marketing department, PARC, and any other functions involved, and how well these individuals and work together. For a successful PARC, it is impossible to overestimate the value of training – both in preparation and onboarding, and ongoing training to ensure continued compliance. [3] Here are some broad fundamentals for being well-prepared:
Marketing
Must be well-positioned to deliver high-quality drafts. This is best achieved through:
- Up-to-date core claims document, using relevant approved documents (e.g. labeling) and examples of previous promotional material
- Involvement of well-trained employees with a working knowledge of MLR aspects for advertising
- Clear understanding of targets and media (form and format)
- Clear project management (planning, scheduling, timelines and tracking)
- Clearly defined interface with PARC
- Understanding of risks and how to mitigate risk with technology
Promotional review committee
- Laying the groundwork early (e.g. two years ahead of expected approval)
- Defining approaches (how the team will work; bring in external coach if necessary)
- Skilled organizational responsible (e.g. scheduling, timelines, tracking, managing versions and approvals)
- Strong interface with Marketing
- Identifying high-risk points and technology to mitigate risk and accelerate turnarounds
MLR reviewers
MLR stands for Medical, Legal, Regulatory and denotes the three key areas of expertise required in a Promotion Advertising Review Committee (and also sometimes structured as a specialized MLR committee). The Medical role reviews and approves aspects such as scientific integrity of claims, and the balance of claims in terms of risks and benefits. Legal ensures that the company doesn’t leave itself open to litigation, providing the quality assurance that material complies with all legal aspects of advertising for medicines in the specific market.
The role of regulatory
Regulatory Affairs (RA) professionals play a complex role in MLR as often they also coordinate the committee process. They focus on aspects such as:
- Overall compliance with regulations and guidelines (e.g. FDA. EU, national bodies for local markets)
- Ensuring that promotional materials accurately reflect the approved labeling and other approved documentation associated with the product
- Compliance with guidelines and regulations in terms of media used and types of promotion
As well as providing expert advice on regulatory aspects, an RA professional often manages the process, which also means coordinating turnarounds and revisions, keeping records of all process steps, clarifying with regulatory bodies any grey areas, and performing all post-market promotional activities to ensure ongoing compliance with changing regulations.
Members of the Promotion Advertising Review Committee will spend most of their time on their primary tasks within their own function. For example, the usual task of a regulatory affairs manager might be to review labeling and packaging. Committee responsibilities come on top of this. Therefore, an RA professional does not want to spend time on poorly managed review and approval rounds. This is where automated proofreading tools can lighten workloads and provide greater compliance.
In each step of reviewing and approving promotional material, the document must be proofread. If you are proofreading manually, this is slow, time-consuming and prone to human error.
How TVT document comparison software helps
- Higher quality: TVT comparison software raises the quality of the draft document because Marketing can compare promotional material with previously approved text blocks and graphics for accuracy (e.g. in labeling, statements in core claims documents).
- Faster turnarounds: TVT speeds up turnarounds. Each time a new version is created from collated comments, the new document can be compared to the previous version and you will immediately see whether changes have been included or not. Version mix-ups can also be avoided.
- Faster verification: If the document has been changed in other places (i.e. where it shouldn’t have been), this will also be immediately apparent in TVT. There is no need to proofread the entire document again manually to make sure no new errors have been introduced.
- More time for primary tasks: Less time will be spent on mundane proofreading tasks, more on primary tasks within the function or on value-adding tasks within the PARC. This eases workloads and stress.
- Workflow integration: TVT can take place within Document, Artwork or Regulatory Information Management Systems and workflows. The entire review and approval process takes place within your own workflow system. Version management is easier.
- Accountability and transparency: Final reports document all actions, can be printed out or sent as a PDF and the recipient immediately sees whether a designated change has been included without having to re-read the entire document.
- Better version management in national markets: Information specific to national markets can be more easily verified against approved documents; correction processes for national market versions become faster and more transparent.
- Consistency across media: Versions for print and online can be easily compared (simply insert a URL for the online version to load the document).
If you would like to see how TVT can help improve your promotional review processes, get in touch with us.
- https://www.fda.gov/media/128163/download
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF
- https://www.raps.org/news-and-articles/news-articles/2023/1/a-marathon-not-a-sprint-ad-promo-training-consider
