Pharmacovigilance is evolving in an era marked by fragility, anxiety, complexity, and unpredictable regulatory shifts—features that define what’s now known as a BANI (Brittle, Anxious, Nonlinear, Incomprehensible) environment.
Join us for an engaging webinar where we’ll unpack how the global flow of safety data and fast-changing privacy regulations — including US 28 CFR Part 202, HIPAA, GDPR, the UK DPA, and emerging regional frameworks — are transforming the landscape for drug safety professionals.
What to Expect:
In this interactive 1-hour webinar, you’ll discover how to use the PDCA (Plan-Do-Check-Act) model to create robust, flexible, and compliance-ready pharmacovigilance operations—even amid growing uncertainty and regulatory flux.
The session includes:
- BANI Framework in Pharmacovigilance: Gain clarity on the BANI concept and why it matters for today’s safety surveillance teams.
- Cross-Border Data and Evolving Privacy Laws: Learn practical strategies for navigating international data transfers and adapting to shifting privacy requirements.
- Applying PDCA for AI, Regulatory Turbulence, and Real-World Scenarios (25 minutes) See how a continuous improvement approach can guide your team through the complexities of AI adoption, compliance, and operational unpredictability—illustrated with a real-world case study.sssss
Webinar Focus:
This session is tailored to deliver practical, ready-to-implement strategies, and it sets the stage for upcoming webinars that will take a deeper dive into topics like AI governance and region-specific compliance.
Join us to equip yourself with the tools and perspectives needed to thrive in the new age of pharmacovigilance.
About the Presenters:
Pradeep Manglani
Vice President – Global Quality & Compliance
Pradeep Manglani carries 20 years of experience in pharma and clinical service industries. He holds a master’s degree in microbiology. He is IRCA Certified Lead Auditor for Quality Management System and is a seasoned auditor with industry experience covering complete gamut of clinical research viz. Pharmacovigilance / Clinical / Bioanalytical. Pradeep has an extensive experience of quality that includes setting up CRO QMS, hosting inspections / external audits, conducting risk-based audits, etc across globe.
Apoorv Sharma
General Manager, Global Quality & Compliance
Apoorv Sharma is CISSP & SSCP-certified Information Security and Data Privacy professional with 14+ years of experience designing and leading enterprise security, risk, and privacy programs across healthcare, technology, and financial sectors. Strong expertise in ISO 27001, ISO 27701, GDPR, HIPAA, HITRUST, and India’s Digital Personal Data Protection (DPDP) Act.
Currently heading Information Security & Privacy Compliance and Quality Services at APCER Lifesciences, with a mandate to build governance frameworks, drive risk-aware culture, and enable scalable, compliant operations. Specialized in privacy-by-design, AI-focused DPIAs, cloud and third-party risk, and regulatory alignment across jurisdictions.
Actively involved in interpreting evolving AI and data privacy regulations, embedding ethical and compliant practices into digital transformation roadmaps.