Indegene's Vladimir Penkrat, AVP, Global Head of Safety & Regulatory Affairs, and Shubha Rao, Sr. Director, Safety Operations, spoke to Outsourcing Pharma (OSP) about the Challenges and Future of Pharmacovigilance (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: Another challenge is the need for a robust and efficient PV system to capture and report adverse events promptly and accurately. We need adequately trained resources and effective processes in place.
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: It is important to note that non-compliance not only poses risks to public health but also has financial implications for MAHs. The maintenance of adverse event reporting and periodic reporting with signal evaluation and corresponding label evaluation all provide evidence of the diligence. MAHs use this evidence to maintain current and compliant data on A.E.s. Non-compliance to this diligence can delay future product development and approvals and cause revenue loss and reputation damage.
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: Companies should also implement effective data management and integration strategies to ensure timely and efficient access to P.V. data. It involves establishing transparent processes for data collection, analysis, and reporting and ensuring that data is stored and shared securely and in compliance with data protection regulations.
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:
Making entire safety processes leaner
Managing volume fluctuations
Enabling suitable prioritization based on regulatory timelines
Eliminating redundant steps in current process
Increasing team's efficiency
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.