What to Expect:
- Understand the principles of risk-based decision-making and their practical application within PV audit planning,
- Identify and assess information security risks affecting organisational PV processes and implement proportionate risk controls, and
- Recognise emerging risks associated with AI-enabled PV activities and the significance of validation, human oversight, and accountability.
About The Webinar
In today's dynamic regulatory landscape, pharmacovigilance (PV) organisations are expected to adopt a proactive and risk-based approach to ensure patient safety, regulatory compliance, data integrity, and operational excellence.
As regulatory expectations continue to evolve, risk management has become an inevitable component of an effective Quality Management System (QMS) in PV, enabling organisations to identify, evaluate, control, communicate, and review the risks that may impact the safety surveillance process.
This webinar introduces a practical and comprehensive framework for applying risk-based thinking within PV, with a specific focus on audit planning, information security risk management, and emerging risks related to artificial intelligence (AI).
Participants will learn how risk management principles can be used to develop and maintain risk-based audit programmes that prioritise critical processes, vendors, systems (IT, QMS, training, etc.), and organisational changes. The session will demonstrate how risk assessment methodologies can support objective audit planning through practical examples.
Considering the increasing digitalisation of PV activities, the webinar will also address the crucial role of information security and data privacy risk assessment within PV operations. The session will discuss practical considerations for assessing risks – from identification to treatment – related to confidentiality, integrity, the availability of safety data, cybersecurity threats, and privacy regulations.
As AI-enabled tools continue to be introduced across PV processes, organisations must also understand the opportunities and risks associated with their use. The session will summarise the potential risk areas related to PV activities, such as AI-assisted case processing, literature screening, and content generation.
Through practical case studies and real-world scenarios, this webinar will enable participants with actionable approaches to strengthen risk-based PV audit planning and information security management and to use AI responsibly while maintaining regulatory compliance and protecting patient safety.
About the Speakers:
Forum Shah is an experienced Quality and Compliance professional with over 16 years of experience spanning Pharmacovigilance, Clinical Research, GxP Quality, Regulatory Compliance, Quality Management Systems, and Inspection Readiness. Dr. Shah holds a Ph.D. in Pharmaceutical Sciences (Pharmacology) and is an IRCA-certified Advanced Lead Auditor.
She is also a certified Six Sigma Black Belt professional, bringing a strong focus on risk-based compliance and contributing to organizational initiatives. She holds extensive experience in end-to-end audit management, Inspection hosting, SOP and quality system management, stakeholder engagement, and quality transformation initiatives across life sciences organizations. Throughout her career, she has successfully conducted and supported more than 200 + audits of service providers, business partners and MAH and has played a key role in regulatory inspections involving MHRA, USFDA, BfArM and Health Canada.
Harshal Vaidya is a seasoned quality professional with over 15 years of experience across pharmacovigilance, quality management systems, regulatory compliance and clinical research. He is a registered pharmacist and an IRCA-certified Lead Auditor with extensive experience in conducting risk-based audits, CAPA and quality oversight. His expertise includes risk-based audit planning, quality risk management, pharmacovigilance compliance, and continuous process improvement.
Harshal actively partners with global stakeholders to strengthen quality systems, enhance compliance oversight, and promote a pragmatic, risk-based approach to patient safety and regulatory excellence.
