Diversity & Inclusion in Clinical Trials

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Description of event:

Our next PCMG Insights session will take place in November, focusing on the vital topic of Diversity & Inclusion in Clinical Trials.

When reviewing your outsourcing plan or strategy, have you included the voice of your patients?

This PCMG Insights session, hosted by the PCMG Sustainability Action Group, explores how Diversity & Inclusion (D&I) can be embedded into the clinical development outsourcing process — from protocol design and patient recruitment through to vendor governance and contracting.

We are delighted to introduce Mandy Budwal-Jagait, Interim Deputy Director for Standards and Compliance at the Medicines and Healthcare Products Regulatory Agency (MHRA), as a speaker for this insights session.

Responsible for overseeing the Compliance Teams (Medicines Inspectors across the product lifecycle), Devices Compliance and Audit, Standards and Regulatory Governance. Mandy is also Chair of the first PIC/S GCP Expert Circle, a co-operation scheme bringing together inspection expertise from global regulators to further learning and development for inspectors. Mandy joined the MHRA in 2014 as a Good Clinical Practice (GCP) inspector within the GCP team, progressing to a Lead Senior GCP inspector. During her tenure at the MHRA, Mandy has held leadership positions managing the Good Pharmacovigilance Practice (GPvP) inspectors from 2020 – 2022 and the GCP Inspectors from 2022 – 2025. Prior to joining the agency, she spent over six years in industry in various clinical operations, quality management and quality assurance roles. Mandy has a BSc (hons) in Medical Biochemistry and a MSc in Toxicology.

With Mandy’s expertise. the discussion will examine:

• The importance of diverse and inclusive clinical trials
• How service providers can help address “D&I gap management” through inclusive protocols and patient engagement strategies
• The impact of regulations such as GDPR on patient data and representation
• Best practices for incorporating D&I principles into service provider relationships and contracts

The panel will share practical examples and strategies to help sponsors and CROs work together to achieve fair representation, ethical recruitment, and sustainable inclusion practices in global trials.

Other speakers include Dr. Susan Tio, Senior Director, Europe Region Lead Diversity and Inclusion in Clinical Trials at Sanofi, who brings over 30 years of experience in clinical development, operations, and leadership roles across multiple pharmaceutical organisations. She also chairs the Pharma.be Clinical Trials Taskforce and is actively driving initiatives to improve fair representation of diverse populations in research.

Jo Humphrey will also speak in the session, Senior Clinical Contract Specialist, Reckitt. She is passionate about challenging the status quo in clinical outsourcing and shaping more agile, transparent, and collaborative approaches to research partnerships. I believe we can move beyond “business as usual” to create smarter models that truly support innovation.

The session will be chaired by Sandra Johnson, an experienced outsourcing and sustainability leader based in Switzerland. With over 20 years of experience in project management and a passion for collaborative, effective teams, Sandra will guide an open discussion on practical, real-world approaches to achieving meaningful inclusion in outsourced clinical research.

Whether you’re shaping outsourcing strategies, overseeing vendor partnerships, or designing patient engagement frameworks, this session will provide actionable insights into aligning operational excellence with inclusive, patient-centered trial delivery.