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Bold thinking and flexibility for marketing application preparation

Posted 07 September 2021 | By Martha Plaza 

Bold thinking and flexibility for marketing application preparation

My experience over the past decade managing the timelines of the marketing application preparation process has taught me two main lessons.

First, no two marketing applications (NDA, BLA, NDS, MAA, etc.) projects are the same.

Second, all marketing application projects can benefit from the same set of three guiding principles.

Before you begin your next marketing application project, consider carefully whether you have covered these three critical bases for a successful, punctual, and high-quality regulatory marketing application.

Integrated teams are essential

Although the easiest way to enable truly collaborative, integrated team interaction is to use a single vendor for all key submission project functions (project management, data analysis, medical writing, regulatory oversight, and publishing), there are ways you can achieve a cohesive and communicative team with multiple vendors. Key strategies include:
  • Overcommunicate. Make sure everyone is interconnected, even beyond what you may consider necessary. This helps avoid siloed communication, delays in feedback, and errors in assumption. Submission team project email distribution lists can make broadcast communications a snap.
  • Use effective document-sharing systems. Online storage or file transfer options, as well as sophisticated shareware editing packages, can make document revisions, chain of custody tracking, group emailing, and even live editing both simple and secure.
  • Perfect the art of the roundtable meeting. By bringing all key stakeholders to the table early in the process — and again whenever needed — your team can ensure that the various decision-makers are present for key strategic planning, comment resolution, reviews, and data analysis planning, saving time and keeping everyone informed from the get-go.
  • Assign ownership and accountability. Document Champions or matrices that designate owners and decision-makers for each document facilitate the collaborative process by ensuring someone is responsible for protecting document integrity and moving each part of the project forward. Their job is to ensure all appropriate members of the team have reached alignment on or approved pieces as needed before passing those materials through to subsequent stages. 

Creativity and flexibility are required

It is not a matter of whether your timeline will shift, but how and when. Be prepared to adapt using some of these key strategies for creative, flexible adjustments:
  • Build a timeline from end to beginning. Starting with the ultimate submission deadline, work your way back to accommodate the needs of every sub-team. Don’t forget to factor in post-submission requirements, agency meetings (and possible requests for changes), and any other non-submission deliverables (e.g., abstracts, posters/conferences, internal data presentations, etc.). Strive to have 90% of the documents into the hands of the publishers one month prior to the submission date thereby reducing the volume that will rolling in during the last few weeks.
  • Work together to find opportunities for efficiencies. When a timeline is tight, look for creative ways to work in parallel, deliver items to the next users on a rolling basis, minimize delays in feedback, and build in advance strategies to mitigate further delays.
  • Make sure everyone is on the same page. Data analysts need to be familiar with statistical analysis plans for all elements of simultaneous submissions. Medical writers can hit the ground running with NDA/MAA modules if they already have contributed to the clinical study report or if their work focuses only on a few consistent content areas. Having large teams that work together to stay informed can ease timeline crunches and avoid inconsistencies.
  • Think outside the box. Proactive planning for potential threats allows you to identify solutions in advance. Dry runs for data analysis can highlight trouble spots before final critical path analysis begins. Rolling delivery of data to medical writing can enable earlier starts on submission documents. Get creative in how you divide and conquer workload to make the submission process most efficient.

Quality is paramount

The fastest submission project in the world is no good if its quality is sub-par. Don’t let tight timelines encroach on your performance.
  • Protect quality review time at all costs. No matter the time crunch, do not sacrifice time required for an effective and thorough quality review. Doing so can result in more costly hold-ups for revisions down the line.
  • Plan effectively to avoid quality compromises. By being proactive about risk mitigation, key stakeholder involvement, early meetings with regulatory agencies, team integration, overcommunication, and informed team members, you can facilitate time savings that do not just protect quality review time — they enhance it.
By bearing in mind these essential approaches for your next marketing application preparation and submission project, you can streamline your processes and optimize performance. Each submission has its unique challenges, but the guiding elements above can ensure your team is ready to meet them.

Read our entire white paper titled Successful Preparation Strategies for Marketing Applications to learn how to achieve your timelines, overcome data analysis challenges and optimize the writing process.  

Martha Plaza is Manager of Regulatory Project Management, Regulatory Affairs, at Veristat


© 2021 Regulatory Affairs Professionals Society.
This article is sponsored and does not reflect the views or opinions of RAPS. The sponsor is solely responsible for the content presented.

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