About C3 Summit
C3 Summit (Conversations on Clinical Content) is part of a series of events that offers sponsors, CROs, and biotech professionals opportunities to share knowledge, gain industry insights, and network. The series has been celebrated for its casual yet informative format and time-efficient, well curated discussions. Previous panels have featured topics such as inclusivity and diversity in patient recruitment, practical applications of AI/ML, regulatory inspection stories and best practices, clinical outcome assessments, future-proofing clinical operations, among other important topics.
Why Attend C3 Summit?
NETWORKING
Connect with industry peers in the life sciences community, spend time with familiar colleagues, and make new connections.
KNOWLEDGE SHARING
Acquire new approaches by hearing strategies and experiences from peers sharing successes and lessons learned.
PRACTICAL TAKEAWAYS
Return to your teams with pragmatic insights that can be directly applied to existing strategies and processes.
CONVENIENCE
Enjoy a day of efficient, insight-packed panels followed by a happy hour in an experience celebrated for its concise format.
ONE-OF-A-KIND EVENT
Experience the synergy that only one of TransPerfect’s world class events can provide—where every discussion and new connection contributes to an energy that cannot be replicated.
Interested in seeing last year’s panel discussions?
Watch our 2025 C3 Summit London panel topics, which focused on diversity and inclusivity in patient recruitment, clinical outcome assessments, digital health, and more.
Speakers
Speakers coming soon
Agenda
9:00 — 9:30 AM
Check-in
9:30 — 9:45 AM
Opening Remarks
9:45 — 10:15 AM
One TMF, One Team: Building Stronger Sponsor/CRO Partnerships
A strong TMF requires shared ownership between sponsors, CROs, and partners. This panel will explore how teams can define accountability, improve communication and transparency, and maintain the TMF as a single source of truth. Panelists will also discuss technology, interoperability, and practical ways to measure successful collaboration. Attendees will gain strategies for strengthening oversight, improving alignment, and creating a more consistent approach to TMF quality and delivery.
10:15 — 11:00 AM
Inside the Inspection Room: What GCP Inspection Experiences Teach Us
Inspection readiness begins on day one, not when an inspection is announced. Panelists will share lessons from GCP inspections and discuss how the TMF serves as critical inspection evidence. The conversation will cover regulatory trends, team training, governance, technology, and ongoing readiness. Attendees will also learn how to prepare staff for interviews, maintain traceability across systems, address gaps earlier, and build confidence beyond the TMF.
11:00 —11:15 AM
BREAK
11:15 — 11:45 AM
Risk-Based TMF Management: Working Smarter, Not Harder
Risk-based TMF management focuses resources on the areas that matter most while maintaining quality and compliance. This panel will explore how Quality by Design can help teams identify TMF risks early and use data to guide decisions. Panelists will discuss targeted oversight, meaningful metrics, automation, and the potential role of AI. Attendees will gain practical guidance for streamlining processes without compromising regulatory expectations or inspection readiness.
11:45 AM — 12:30 PM
The State of AI in Clinical Trials: Progress, Barriers and Practical Lessons
AI is already part of clinical trial operations: in data management, automation, and increasingly, regulatory submissions. The question most organizations are wrestling with isn’t whether to adopt it, but how to do it without cutting corners on scientific integrity or compliance. This panel addresses that directly. We’ll look at what’s driving demand from sponsors, sites and patients; where AI adoption is working and where it’s breaking down; and what it takes to submit an AI-assisted package that holds up to regulatory scrutiny.

Gillian Gittens, Director of eClinical Strategy and Solutions, is a TMF industry veteran with over 25 years’ experience. Gill has a wealth of insight and expertise in managing TMF services and delivering ongoing customer success across all aspects of TMF operations. A member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative, Gill has key expertise and insight in industry best practice, regulatory guidance and the future of TMF management.

Paul Dillon is a Real-World Evidence (RWE) Strategy Lead at UCB, where he develops evidence strategies to support drug development, market access, and innovation across immunology and emerging therapeutic areas. His work focuses on leveraging real-world data, advanced analytics, and AI-enabled approaches to generate actionable insights that inform clinical development and healthcare decision-making. Paul has led RWE strategies for multiple early- and late-stage programs, with particular expertise in integrating data science and AI into evidence generation. He is passionate about AI’s potential to transform how healthcare evidence is created and applied.

Nick Goelen, PhD, is a clinical research professional with 10 years of experience spanning bedside research, project management, and Phase I–III clinical development. His expertise includes gastroenterology, rare paediatric diseases, neurology, nutrition, and medical devices. Having helped build a MedTech start-up from the ground up, Nick understands the balance between speed, innovation, and the rigor required for successful clinical development. At 2 Bridge, he helps clients navigate operational challenges and accelerate progress while leading initiatives to explore the smart, efficient, and compliant use of AI in clinical development and day-to-day operations.

12:30 — 1:45 PM
Networking Lunch
1:45 — 2:15 PM
Rethinking Patient Engagement Across the Clinical Trial Journey
Patient engagement has moved beyond simple consultation, with regulators now recognizing patient experience data as essential to relevant, inclusive research. Yet as guidance from the FDA, EMA, and HTA demands more rigorous qualitative methods and documentation, patients are calling for earlier, more authentic involvement. This session examines how sponsors and regulators are rethinking engagement across the clinical trial journey, from digital platforms and AI-powered materials to targeted segmentation and co-created study documents that improve recruitment and retention. We’ll address the complexities of global compliance and cross-functional collaboration, and what works when translating patient insights into regulatory and real-world impact. Drawing on emerging standards and real-world examples, the discussion will highlight the shift from collecting patient data as a formality to embedding patient partnership at the core of clinical development.


Michaela Dinboeck leads Novartis’ global Patient Engagement (PE) team, overseeing the strategy and implementation of patient-focused medicines development. Her team systematically embeds patient experience information throughout the medicine lifecycle, from early-stage development through regulatory submissions. Prior to leading PE, Michaela held commercial and general management positions for more than 20 years across the pharmaceutical and medical device industries and lectured in business at universities in Bolivia and Malaysia. She serves on the boards of Novartis Pharma GmbH Germany and Patient Focused Medicines Development (PFMD), as well as the Nomination Committee of the National Health Council in the US. She also co-authored the patient involvement chapter in Patient Involvement in Health Technology Assessment.

Judit Magos is a Clinical Operations Manager at Viatris Innovation with 15 years of international experience in clinical trials for drugs and medical devices. Her work spans multiple phases and therapeutic areas, including oncology and biosimilars, across both CRO and sponsor settings. She specializes in clinical operations and trial oversight, with a strong focus on collaboration, team engagement, and efficient study delivery. Judit is passionate about advancing clinical research to improve patient outcomes and also holds a degree in medical and health science translation.

2:15 — 3:00 PM
The Future of Medical Information: Navigating AI, Demonstrating Value & Staying Indispensable
The rise of AI and large language models is disrupting how information flows in healthcare. Stakeholders—from HCPs to patients to internal teams—increasingly expect instant, personalized answers. For Medical Information (MI), this presents both a challenge and an opportunity. How do we ensure that accurate, compliant, and scientifically rigorous content reaches the right people at the right time? How do we demonstrate that decades of therapeutic expertise cannot be replaced by an algorithm? And critically, how do we make the case for MI’s value to leadership and external stakeholders alike? This panel convenes experts across Medical Information, Medical Affairs, and digital innovation to discuss strategies for thriving in an AI-augmented world, where technology amplifies rather than replaces the human touch.

Alessandra Grossi is Medical Operations Director at TransPerfect UK, with over 30 years of experience in the pharmaceutical industry. She has held leadership roles in Medical Information at local, regional and global levels, as well as positions in Medical Operations, Systems and Governance at Pfizer. Alessandra has led numerous system implementations, process harmonisation initiatives and innovation programmes. She is passionate about advancing Medical Information and Communication and is committed to driving its evolution through technology adoption and innovative practices, enhancing efficiency, compliance and the overall impact of medical affairs functions globally.

Michelle Bridenbaker is a toxicologist, critical care nurse, health communicator, and executive MBA with more than two decades of experience. She is passionate about bridging the gap between science and effective communication to ensure critical scientific and medical information reaches people around the world.

Lillian Auberson has more than 20 years of experience in global and regional medical affairs leadership roles across large pharmaceutical and rare disease companies, including Novartis, Roche, Actelion, Alexion, and argenx. She has developed strategic and innovative above-country operational frameworks in highly regulated settings, including medical information and patient support programs (PSPs). Together with industry peers, Lillian has helped elevate the strategic importance of medical information for customer engagement and co-founded both the annual Medical Information Conference in Europe and the Medical Information Leaders Europe (MILE) association. She is currently on assignment as Head of Quality Innovation and Operations at argenx.

Beatrice Omisakin, MPharm (Hons), is a healthcare and digital transformation leader with more than 24 years of experience in clinical pharmacy and global pharma, focused on applying AI, NLP, and automation to modernize medical information. As Head of Medical Information, EMEA at Takeda, she deployed AI/NLP analytics across 10 global brands and launched a medical information website serving more than 50 countries. Her previous roles at Novartis, Bristol Myers Squibb, Merck Sharp & Dohme, and the NHS in the UK span European and global medical information leadership. A GPhC-registered pharmacist, Beatrice is completing an MIT Professional Certificate in AI-Enabled Technology Leadership as part of the Chief Technology Officer Program.
3:00 — 3:45 PM
Beyond Compliance: How Regulatory and Safety Are Redefining Risk, Collaboration, and AI
The roles of Regulatory Affairs and Pharmacovigilance are rapidly evolving beyond their traditional compliance functions. As AI reshapes pharmaceutical development, organizations face a common challenge: no single team, and no single technology, has all the answers. Success will depend on how Regulatory, Safety, and Quality collaborate to build governance frameworks, manage risk, and enable innovation together. This panel brings together industry leaders to discuss how these functions are becoming strategic partners, the governance models needed to adopt AI responsibly, and the evolving expectations of health authorities. Panelists will share practical perspectives on balancing innovation with compliance, managing risk across the product lifecycle, and preparing organizations for the next generation of regulatory and safety operations.


Montse Bascompte is a pharmacist with an MSc in Pharmaceutical Industry and more than 25 years of experience in the pharmaceutical sector. She has led global regulatory portfolios, international teams, and transformation initiatives, combining deep regulatory expertise with a strong focus on business impact, collaboration, and people development.

Toni Burón Vidal is Global Head of Countries & Regions Patient Safety and Pharmacovigilance at Novartis, based in Switzerland. He brings extensive experience across patient safety, pharmacovigilance, and medical affairs, with previous senior roles at Novartis and Johnson & Johnson. A physician by training, Toni has worked across global, regional, and country-level organizations, giving him a broad perspective on how regulatory, safety, quality, and medical functions must evolve in an increasingly complex and data-driven environment. He brings particular insight into the future of pharmacovigilance, the strategic value of safety and regulatory functions, and the opportunities and responsibilities created by new technologies, including AI, in highly regulated healthcare settings.
3:45 — 4:00 PM
Closing Remarks
4:00 — 5:30 PM
Networking Cocktail Reception
FAQs
Is this event free?
Yes, there is no registration fee associated with this event. However, spots are limited and you will receive a confirmation email once your seat is confirmed.
Will travel and hotel be provided?
No, TransPerfect does not provide travel arrangements for C3 Summit attendees.
Who is the event for?
C3 Summit is geared toward executives, directors, and senior managers within Pharma, Medical Device, Biotech, and Contract Research Organizations. Spaces are limited and will be prioritized accordingly, therefore eligibility is subject to approval by the TransPerfect Life Sciences team.
How can I become a panelist for future C3 Summits?
Please fill out the speaker interest form below so that we can find the best speaking opportunity for you.