Executives involved in the review of regulatory advertising and promotional review committees, have had always faced continuous challenges before.  Challenges such as the ever-evolving FDA regularity updates, legal and compliance issues, conflicts across the concerned teams and various stakeholders, and keeping pace with today’s modern marketing cycle to to increased use of social media, marketing automation and digitization,

The COVID pandemic, however, has drastically undermined our current work environment, affecting business-critical life cycles and forcing the majority of the global workforce to work remotely.  The level and intensity of complications arising due to the remote work culture vary from business to business and company to company and promotional review teams are no exception.

The Promotional Review Committee is a complex blend of cross-functional teams comprising experts from various departments such as marketing/promotions, medical affairs, legal, regulatory, and, compliance.  When we use the term ‘experts’ here, it unequivocally means professionals who are extremely knowledgeable, precise, and, constantly up-to-date with FDA regulations and guidance to keep their marketing efforts in compliance.

PRC’s core objectives are to ensure that their company product’s promotions, claims, and, training modules are medically accurate and strictly in compliance with the FDA (Federal Drug Administration) standards and other regulations or laws.  This safeguards their companies and mitigates the risk of receiving warning letters and heavy fines due to non-compliance and false claims.

The industry as a whole is quickly pivoting to learn how to work effectively in this remote environment, but there some are adapting quicker than others and are learning new best practices in this new normal.   When it comes to a complicated process such as the Promotional Review Committee, where the stakes are exorbitantly higher, it is imperative to work in cohesion to create process harmonization, control costs & quality, and analyze & anticipate unforeseen challenges in the future.

Challenges of Working Remote

One of the fundamental objectives of the Promotional Review Committee is to take control of the MLR review process.  We are at an age where automation and digitization dominate almost every aspect of the global economy.  In this hyper-connected world where marketing content is being deployed across various digital channels such as emails, websites, mobile apps, social apps, video ads, etc, it is crucial for companies in life sciences industry, to ensure that medical, legal, and, regulatory reviews are precise, accurate, efficient, and, risk-averse.

This might sound a lot to take in but this is exactly what each member of the PRC analyzes and executes to maintain compliance and prevent warning letters, or fines due to false claims.  Mentioned here are a few challenges that most companies face in a remote-work environment.

  • Communication between Multiple Teams: Not being physically present tends to make communication difficult among teams.  Remote work not only effects multiple teams in tandem but also fragments communication within a single team too. Constant knowledge updates with regards to regulations and law is key for the PRC to work in sync and guarantee that all quality controls are in place.  Unlike most other professionals who usually communicate within their team or a couple of stakeholders, the Promotional Review Committee needs to correspond with multiple departments and stakeholders.  This creates a communication gap and may cause disputes and complications within the process.
  • Remote Collaboration: The majority of the workforce is not trained on collaborating effectively in a remote work environment.  Tracking individual tasks and productivity is problematic and more time consuming, especially since there are multiple teams and stakeholders involved in the PRC.
  • Tracking tasks: The PRC is a group of teams with each member tasked with different duties.  Unless there is a streamlined process flow with appropriate hierarchy in place, keeping a track of tasks is difficult and time-consuming.
  • Access to Tools: Connectivity issues due to network speeds or delay in providing access to concerned individuals are some of the primary issues that ensue while working remotely. Having seamless access to tools that assess risks and prepare team members for MLR reviews is critical for all PRC members.  These tools also accelerate asset delivery, improve brand consistency, drive innovation, and control costs.

We have asked a few questions to our speakers and here are their responses:

Q1) What do you think are the keys to success for Promotional Review Meetings in the current environment?

Frequent communication is essential. Loss of face-to-face interaction increases the need for building trust and comradery. Flexibility is key. The new environment has created a lot of changes for everyone that are happening quickly. We’re all figuring this out together. Assume positive intent. Especially with less face-to-face interaction, this is critical. Everyone has (or should have) the goal of making compliant, effective materials that move the business forward while protecting patients, the brand, and the company.

 

A strong process around submission requirements and management of agendas. Do not waste time in meetings talking about process or if this piece is “ready to be there”.”

Preparedness from both sides – if there is a contentious issue, have all the facts before the meeting in question.

Do not challenge – the Promotional Review environment is inherently “us vs. them”. If you can enter the meeting, as a marketer or reviewer, with a seeking to understand the attitude and be solutions-oriented, you’ll achieve strong results and be more efficient simultaneously. Additionally, this prevents everyone from going in with pre-conceived notions, which can shut conversations down quickly.

Q2) How has your job functions been impacted since working from home as it relates to promotional review?

The functions themselves remain the same. The tools and flexibility to make it happen effectively have changed. That’s where the challenges lie.

 

Managing a virtual meeting is tough – we don’t consistently use video and I wish we would because the lack of body language poses significant challenges for the coordinator

 

At the upcoming Promotional Review Virtual Summit taking place September 24-25th, our faculty of over 20+ speakers representing companies of all sizes, offer valuable insights on how they have adapted and will provide attendees a better understanding of the end-to-end process flow of promotional reviews and MLR reviews.

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