ICH E6 (R3) in Focus: Service Provider Oversight – A Site’s Perspective
| Date: | 7th May 2026 |
| Start time: | 2-3pm BST | 3-4pm CEST | 3-4pm SAST |
| Duration: | 1 hour |
| Location: | Virtual – Online |
| Member Price: | £0 + VAT |
| Non-Member Price: | £0 + VAT |
Booking Link: click here to book
Description of event:
ICH E6 (R3) in Focus: Service Provider Oversight – A Site’s Perspective
PCMG is delighted to announce an Insights session presented by Almari Conradie (TB Alliance), Bernice Irvine (University of Cape Town Lung Institute), Kim Narunsky (University of Cape Town Lung Institute) and chaired by Sandra Johnson (PCMG Sustainability Action Group).
In 2024 during the global assessment of the impact on the release of ICH E6R3 some stakeholders mentioned that sponsors and service providers appeared to be a step ahead of sites when it came to understanding and preparedness for ICH E6 (R3). Additional responsibilities were assigned to sites, including the implementation of Site Vendor Oversight as a critical component.
Two years later, we will hear insights from a sponsor, and a Site QA Manager and Principal Investigator from a LMIC on how they are facilitating the smooth implementation of a Site Vendor Oversight SOP and oversight templates to ensure appropriate, well-documented vendor oversight.
Key discussion points
- Embracing the learning curve – collaborating and developing a shared understanding of the impending changes
- Review and update resources including checklists (e.g., Service Provider Audit Checklist [Technology] and SOPs (e.g., Service Provider Qualification and Oversight)
- Staff training
Who should attend
This webinar is relevant for experts working in academia, biopharma, CRO organisations, and sites, including clinical operations and study delivery teams, outsourcing and vendor managers, quality and site staff supporting trial delivery across the globe.
Speaker Information
Almari Conradie
Director of Clinical Operations, TB Alliance
Almari Conradie is Director of Clinical Operations at the TB Alliance, with over 28 years of experience in global clinical research. She leads clinical operations and mycobacteriology laboratory operations across Phase 1–3 tuberculosis trials conducted in Africa, Asia, Europe, and the Americas.
Almari has played a key role in advancing innovative TB treatment regimens and contributes to major international collaborations, including ERA4TB and UNITE4TB. She holds a Masters in Pharmacy and with this background and extensive experience across multiple therapeutic areas, she brings deep operational expertise and a strong focus on delivering high-quality clinical trials in global health settings.
Kim Narunsky
Clinical Operations Manager, University of Cape Town Lung Institute
Kim began her career as a sub-investigator in 2006 with the establishment of the University of Cape Town Lung Institute Clinical Research Site. Over the years, her role within the unit has grown significantly, and she currently serves as Clinical Operations Manager.
Prior to entering the research field, Kim worked with the National TB Program, where she developed key relationships that have continued to support and shape her work in the tuberculosis research space. Her role continues to evolve, with a strong focus on mentoring and developing new staff as part of her commitment to succession planning.
Quality Assurance Manager, University of Cape Town Lung Institute
Bernice Irvine is a Quality Assurance Manager at the University of Cape Town Lung Institute with extensive experience in clinical research. She began her career in 2002 at a large Clinical Research Organization, initially working as a monitor before progressing to the role of Project Manager.
In 2012, she joined the Lung Institute, where she has since built strong expertise in quality management, regulatory compliance, and clinical research processes, helping to ensure the integrity and high standards of the institute’s research.