Q&A with Outsourcing Pharma: Challenges and Future of PV Compliance

Penkrat: One of the main challenges is the increasing volumes, and sources of A.E. (Adverse Events) reported data. This has resulted in the need for diversified systems to capture and store this data and then follow through to ensure proper data handling on time. At the same time, the current landscape has evolved into a globalized and highly decentralized environment.

Rao: Regulatory bodies monitor compliance through review of data submitted by the MAHs and conducting regular audits/inspections. They provide guidelines, training, and FAQs on their website to help Market Authorization Holders (MAHs) understand the regulatory requirements. Consequences of non-compliance can range from warning letters and levying fines to suspension or revocation of marketing authorizations and taking legal action.

Penkrat: Companies must establish an efficient P.V. system with adequate resources, trained staff, and robust processes and procedures. It includes clearly understanding regulatory requirements and guidelines and ensuring that all stakeholders involved in drug development, manufacturing, and distribution adhere to these requirements.

Rao: Many organizations use generic tools to track compliance, such as emails, excel spreadsheets, SharePoint, or in-house tracking systems. These tools are not efficient or scalable and may lack a single source of truth for compliance information. Therefore, automation is a vital element that can help businesses to achieve five key goals:

Penkrat: We expect the focus to increase on using new technologies such as machine learning. It can improve the detection and assessment of safety concerns and risks as a mechanism to draw attention to potential issues with patient data. Ultimately, we can shorten the time to reporting and reduce the potential for missed A.E.s.

Penkrat: Manpower alone cannot manage the increasing data volume and intricacies. This is where technology solutions will become mission-critical. Expect that more than 80% of the top 100 pharma companies will commence a re-examination of their safety platforms and supporting technologies in the upcoming years. Pharmaceutical organizations should perform the following activities - audit organization's current practice for compliance, advocate for investments in custom software solutions, better alignment between label database and P.V. database

Rao: MAHs can ensure compliance with P.V. regulatory obligations by implementing robust P.V. systems, regularly monitoring the safety profile of their products, and reporting adverse events and safety concerns in a timely manner. They should also have processes to address and respond to requests for information from Health Authorities (H.A.) and address any issues raised in H.A. assessment reports. It is also essential for MAHs to ensure that their business partners and service providers comply with P.V. regulations and submission timelines.