Pharmacovigilance in Preventive and Therapeutic Medicine

The importance of systematic pharmacovigilance is being gradually acknowledged by all companies. Additionally, the importance of patient-centricity is increasing, and there are more publicly available safety data as a result.

Therefore, all businesses are increasingly aware of proactive pharmacovigilance, regardless of their size and product line-up.

Regulations for risk management and product safety have undergone a period of significant change, with regulations in developed regions becoming stricter and those in emerging markets evolving quickly.

The importance of emerging markets has caused a shift in the market’s geographical focus. Pharmacovigilance operations have become more complex because of alliances created between various international stakeholders, including generic producers, distributors, service providers, and technology providers.

Additional elements that add to this complexity are the change in the ratio of small and large molecules, the shift in the therapeutic area’s focus, and the rigor required to gather safety data for new classes of products.

Determining that all safety systems and PV practices used by an organization firmly tie into a single, truly global PV framework is crucial. This is because proactive PV depends on compliance with various regulations and guidelines. Establishing such a framework takes much more than just collecting safety information from distributors, partners, and affiliates.

To establish a global PV strategy, a global PV system was established.

Global Pharmacovigilance Network

A PV system’s structure, procedures, and intended results define it. It is described as a system used by a company to carry out its legal obligations and tasks related to PV. It was created to track the security of approved pharmaceutical products and identify any changes to their risk-benefit ratio. All licensed products must be protected from adverse drug reactions (ADRs) by a strong, global system, no matter where they are licensed or where they are sold.

There must be a strong, global system in place to record and manage adverse drug reactions for all licensed products. This is true wherever similar products are sold in the world, and wherever they are licensed in the markets. A global system must also be able to execute all downstream tasks, including regular reporting and safety surveillance.

A company’s corporate quality system must include a global PV system as a fundamental component. It is complicated by nature and necessitates the seamless cooperation of several parties such as company divisions, such as regulatory and medical affairs, as well as commercial, corporate, customer service, and complaint intake departments, as well as the entire company’s leadership.

Therefore, the system must consider the accountability and responsibilities of each of these entities in terms of how they directly or indirectly relate to safety. Additionally, harmonization and standardization of process workflows are essential to consider their interdependencies.

The following crucial components are necessary for a successful global PV system, and MAHs may use specialty safety consulting and service providers who can suggest and implement them:

There are various ways to explain the detailed PV Quality System with documented procedures.

1. A sufficient number of knowledgeable and skilled employees is required in all areas of operations.
2. Effective business collaborations with partners, associates, and suppliers. A few of these include contracts with suppliers and business partners, as well as the sharing of safety information.

The PV system’s final and most important component, corporate level structure, does two things:

 1) aligns the various entities that are within its scope;

 2) makes it possible for compliance from all business units (BUs) and therapeutic areas (TAs); and 

3) strengthens the connection between the main PV function and specific affiliates.

The system requires responsiveness to emerging trends, including new operating structures, emerging public data sources, and providers. Effective oversight of safety-related activities across all entities in scope is also crucial.

Developing and Planning a Global PV System Strategy

• There are numerous challenges for organizations of all sizes when it comes to establishing a global PV system, regardless of the type of organization.
• The risk of non-compliance and the lack of internal availability of safety expertise may be a significant challenge for a small business with a finite number of products.
• The number of distributors and business partners, as well as the manufacturer’s focus and diligence on product safety, may present the biggest difficulties.
• The most significant challenges for large businesses with a diverse product mix and extensive global reach may be ensuring consistent worldwide SOPs for safety and risk management across product categories and regions, as well as efficient oversight of all parties.
• The foundation for establishing an efficient system is a carefully thought-out strategy that considers both the organization’s short- and long-term business plans.
• There must be a thorough examination of the present situation and an analysis of the gaps in terms of people, procedures, and technology.
• A thorough understanding of the various regulatory requirements, as well as the global organizational structure and operating model necessary to enable the crucial level of oversight and control, is required. An ideal framework for setting up a successful global PV system will be created.
• A comprehensive understanding of safety laws and international business practices will be utilized to develop a strategic plan.

Synopsis

Globalization of the economy and the impact of cutting-edge technologies on healthcare delivery will present significant challenges and opportunities for life sciences decision-makers. Medical knowledge, techniques for its analysis, and emerging sources of knowledge are transforming the current reactive system into a proactive one.

 Globally, regulations are also changing to take a more proactive stance, but they still tend to be too procedure-focused, which frequently stifles innovation. Furthermore, the technical resources necessary for a successful benefit-risk analysis are still in the early stages of development.

 All safety systems and PV practices must be tightly integrated into a truly global PV framework for organizations to succeed in the current environment.

An approach that considers all relevant factors is required to set up such a framework. This system considers the responsibility and commitments of all entities, and how they relate to safety.

Our mission at Sollers College is to provide students with the fundamental information and practical skills to meet the demands of the rapidly expanding healthcare, life science, and pharmacovigilance fields. 

Graduates from Sollers will advance into rewarding careers with leading international corporations. 

To learn how we can assist you in formulating your future, call or drop by today.