Combination product safety reporting remains a challenge for pharmacovigilance teams due to uncertainty over which regulatory framework applies when products combine drug, device, and biologic components. Misclassification can cause confusion about reporting authority, systems, formats, and timelines, increasing risks of duplicate or incomplete reports.
This webinar offers a clear, practical overview of navigating these challenges in the US, UK, and EU. It explains how regional regulatory pathways shape safety reporting, how product type and primary mode of action determine the application of pharmacovigilance or device vigilance rules, and how report types and timelines interrelate in real cases.
Focusing on core regulatory logic rather than complex legal details, the session helps attendees quickly evaluate their processes and identify gaps or inefficiencies.
Key Takeaways:
This session summarises key concepts and subsequently translates them into concrete, usable takeaways. By the end of the webinar, attendees will be able to understand:
- Classification decisions that shape combination product safety reporting.
- Inspection Recognize
- High level reporting pathways for drugs, devices, and in vitro diagnostics in the US, the UK, and the EU.
- How different report types and timelines interact across constituent parts.
- How internal workflows can be structured to enable pharmacovigilance and device vigilance teams to operate with a shared, classification first reporting strategy.
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About the Speakers:
Binoy Sharma is a seasoned Pharmacovigilance leader with over 18 years of experience across pharmaceutical companies and CROs, with deep expertise spanning the full spectrum of PV domains. Currently serving as Vice President – Pharmacovigilance, he drives both strategic vision and operational excellence in global drug safety, leading initiatives in regulatory compliance and the adoption of innovative technologies.
He works with pharmaceutical organizations to address complex operational challenges across all pharmacovigilance verticals and brings extensive experience in managing major safety databases and systems. Binoy has successfully led large, cross-functional teams and managed complex integrations of QPPV and Local QPPV frameworks, ensuring robust governance and seamless regulatory alignment across regions.
His expertise encompasses end-to-end pharmacovigilance systems, including leading audits and regulatory inspections. Binoy consistently delivers scalable, high-quality safety solutions that strengthen compliance and enhance patient safety outcomes.
Khusro Mirza is a pharmacovigilance professional with over 12 years of experience in global drug safety, with a strong focus on drug–device combination products. As Pharmacovigilance Senior Manager and Client Delivery Head at APCER Life Sciences, he oversees end to end safety delivery for complex product portfolios, with a particular focus on drug–device combination products and the practical challenges of meeting divergent regulatory expectations in multiple regions.
He works closely with global pharma and biotech clients to design inspection ready safety processes, optimize case handling and reporting workflows, and translate evolving guidance into workable operating models for pharmacovigilance and device vigilance teams. Drawing on his hands on experience at the interface of regulation and operations, Khusro brings a pragmatic, “what works in real life” perspective to combination product safety reporting—making this webinar especially valuable for PV teams looking to strengthen compliance while keeping their processes efficient and scalable.
