Organizational models

In this continuously evolving context, having a robust Quality Assurance System (QMS) is critical and is the cornerstone to ensure the excellence of all Exploitant site activities, from manufacturing to the patient. Therefore, a structured QMS across functions has become unavoidable at the corporate and affiliate levels. Such a system must guarantee a controlled risk management, as pharmaceutical activities have a critical role in bringing different stakeholders together.

Quality assurance is a key capability in a company’s organization enabling compliance with regulations, with established good practices for healthcare stakeholders and patients. Through a local QMS, the CPO has the duty to organize and monitor all the activities under his/her responsibility (i.e. French Exploitant site activities). All initiatives led by the French CPO must also be aligned with the corporate organization, while maintaining his/her independence in decision making regarding the pharmaceutical products and activities on the French territory. It is therefore appropriate that the CPO manages the verticalization of functions such as Regulatory Affairs, Safety, Quality, etc.

As the scope of pharmaceutical activities grows in French affiliates with the different ongoing trends, new challenges of organization arise requiring a single point of view.

On the French territory, 3 main organizational models have been identified through our benchmark for pharmaceutical activities (Figure 4), based on the company profile and organization’s history around the Chief Pharmaceutical Officer (CPO) role:

  • Regulatory focus model

The CPO is positioned as the head of Regulatory Affairs (RA), reporting directly to the global RA function and via a dotted line to the local GM. The local RA affairs team reports directly to the CPO (including Pharma Sales Rep Certification), with all remaining functions under the CPO scope reporting directly or indirectly to the CPO (local quality, safety and medical information). (See Figure 4)

  • Consensus model

The CPO is independently positioned as the head of Pharmaceutical Affairs, with a direct line to the local GM. The Regulatory, Pharma Sales Rep Certification and local Quality functions report directly to the CPO, with the remaining functions under the legal scope reporting indirectly to the CPO (safety and medical information). (See Figure 4)

  • Quality focus model

The CPO is positioned as the head of Quality, reporting directly to the local GM and indirectly to the global Quality function via a dotted line. All quality operations and Pharmaceutical Sales Rep responsibilities report directly to the CPO, with the remaining functions under the CPO scope reporting indirectly to the CPO (Regulatory Affairs, Safety and Medical Information). (See Figure 4)

The Pharmaceutical Affairs organization sizing is highly depending on multiple factors as number of products, product complexity, product portfolio mix on the life cycle, shared activities between local, regional and global level as product registration, label validation, management of clinical studies…

Note: The scope of local quality in French affiliates always includes the management of pharmaceutical local operations through an appropriate Quality Management System notably covering Distribution Quality (DQ) and Product Quality (PQ) and if needed Manufacturing quality.

 

 

 

 

 

 

 

 

 

 

 

 

Figure 4: Organizational models for pharmaceutical activities in French affiliates

Depending on the organizational model in which the CPO operates, it is more or less challenging for him/her to execute the responsibilities linked to the role. Nevertheless, it is clear that a CPO must demonstrate specific skills enabling him/her to successfully lead Exploitant activities. When articulating local, regional and global requirements on pharmaceutical affairs activities, a CPO must demonstrate true leadership driven by a strategic vision, with an ability to communicate strongly in a trustworthy manner, along with high persuasion and negotiation skills.

A CPO should also be able to assimilate versatile expertise, while being able to delegate in an organized and methodical approach. These skills will help a CPO maintain his/her legitimacy in an advisory, diplomatic and facilitating role to ensure a Next-Generation Pharmaceutical Affairs.

Next-Generation of Pharmaceutical Affairs

To maintain current activities and assess opportunities for growth in a continuously changing regulatory and healthcare environment, the CPO must ensure the excellence of the entire pharmaceutical operations to face challenges as well as align with company strategy and culture. Oversight, monitoring and management of all pharmaceutical activities call for a pilot’s cockpit facilitating the CPO’s role and responsibilities to enhance his/her decision-making performance. To achieve this, the CPO will utilize all the new technical solutions and systems in order to better manage the entire data which are under its cross-functional responsabilitity (product data, pharmacovigilance data, supplier data, key social listening data ...).

A new and optimized structure must ensure the execution of the company’s and CPO’s strategy for short-, mid- and long-term goals. This goes beyond the traditional continuous improvement methods (Lean, Six Sigma, Kaizen, etc.), and requires a robustly designed Quality Management System (QMS) for all pharmaceutical affairs activities (See Figure 5).

Figure 5: Scopes of quality for an Exploitant Site

Through a QMS, the goal is to develop one single, integrated level of management system with the ideal flow. It is an element of organizational leadership that focuses on the sustainable improvement of adapted and accurate performance and monitoring metrics.

For a next-generation structure to succeed, it requires to build an integrated model composed of:

1. An extended software platform seamlessly plugged into all currently used systems (local or corporate, internal and external) and without any disturbance to day-to-day activities (API, low code interface, etc.) maximizing automation.

  • A monitoring and verification system (monitoring of indicators, audits, etc.) to check the compliance and consistency of practices, including subcontractors/service providers.
  • A platform using the power of technologies to acquire and analyze broader insights using data captured through real world evidence, digital assets, IoT, etc. For example, this can complete the benefit/risk balance for the products portfolio and utilize Machine Learning to build predictive models improving patient safety by using adapted beyond-the-pill solutions.

2. A data visualization platform leading to the best decision intelligence for the Responsible Pharmacist and distributing pertinent information to other stakeholders. Normal as well as abnormal results must be clearly visible to manage revenues, costs and all risks related to pharmaceutical affairs activities.

3. A clear and extended shaping of the next-generation operating model, governance, performance and operations metrics defining the appropriate scope of performance measurement, continuously adapted with the evolving environment and aligned with corporate goals (including static and dynamic indicators/KPIs).

  • Quality policies must be clearly established between the CPO and GM and be regularly updated (values, coherent and measurable objectives, performance indicators, audit programs, homogeneity and conformity of practices, etc.)
  • A clear governance must also be established and respected: Executive Committee, Quality Committee, ad hoc committees, etc. (permanent list of participants, real-time minutes with decisions taken, follow-up of actions in progress, etc.)

The success of a new structure does not only rely on a perfectly calibrated QMS, but also requires an adapted team and organization culture. This culture is built around the reinforcement of management with sub-teams and daily driven collaborators.

A next-generation pharmaceutical affairs structure, with the corresponding QMS, governance and team culture, will allow the Chief Pharmaceutical Officer (CPO) to reinforce coordination within functions, as well as with global functions by increasing visibility, communication and coordination; and gaining confidence by collaboration. This new structure will also support the current business acceleration, ensuring success excellence in launch and access; therefore, securing an affiliate’s business. In case of an audit or inspection by health authorities as well as internal entities, the upgraded Quality Management System will provide all the information related to the monitoring and control of activities by providing a quick overview of the quality and compliance levels by function.


Authors:

  • Corinne de Villeneuve, Director Life Sciences
  • Françoise Robinet, French Pharmaceutical advisor
  • BearingPoint Life Sciences team
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