About the Session
With global regulators tightening oversight on clinical trials, drug safety, and ethical marketing, pharmaceutical and biotech organizations are facing heightened scrutiny. At the same time, breakthroughs in AI-driven research, cross-border collaborations, and accelerated approvals raise complex regulatory and ethical challenges.
This global roundtable gathers legal, compliance, R&D, and ethics professionals in pharma and biotech to discuss:
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Emerging regulatory updates across the U.S. FDA, EU EMA, India CDSCO, and global markets
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Clinical trial governance, data sharing, and cross-border ethics
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AI, patient data, IP protections, and innovation risk
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Culture of compliance and ethical conduct in high-growth science environments
All GC360 members will receive post-event access to the full session recording and practical toolkit via GC360Flix.
Agenda Program
Date: March 12, 2026
Pharmaceuticals & Biotech: Regulation & Ethics
12:00 – 12:10 PM GMT | Welcome & Introductions
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Moderator’s session kickoff and objectives
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Speaker intros: “Which regulatory or ethical issue keeps your team up at night?”
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Live poll: “Which area poses the greatest compliance risk in 2026?”
12:10 – 12:40 PM GMT | Challenge 1: Global Regulatory Changes & Trial Compliance
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EU CTR, U.S. Accelerated Approval, India New Drugs Rules
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Clinical data governance, ethics committee alignment, and sponsor responsibilities
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Post-market surveillance and pharmacovigilance
What You'll Gain:
Guidance on aligning with evolving trial and approval regulations worldwide
12:40 – 1:10 PM GMT | Challenge 2: AI, IP, and Patient Data in Pharma Innovation
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Governance of generative AI in R&D and regulatory submissions
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Managing sensitive health data, consent, and data transfers
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Protecting innovation under increasing IP scrutiny
What You'll Gain:
Compliance frameworks for AI-assisted drug development and data ethics
1:10 – 1:40 PM GMT | Challenge 3: Culture of Integrity & Ethical Oversight
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Marketing conduct, off-label promotion, and transparency laws
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Internal controls for whistleblower reporting and misconduct prevention
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Building ethical tone at the top in scientific teams
What You'll Gain:
Templates for internal codes, reporting procedures, and integrity programs
1:40 – 2:00 PM GMT |
Live Q&A & Closing Reflections
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Participant questions and expert insights
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Final takeaways: “One compliance initiative to act on this quarter”
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Post-event toolkit and GC360Flix access
Post-Event Toolkit Includes:
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Actionable Takeaways from Speakers
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Ethical Conduct Policy Sample or Regulatory Checklist (if shared)
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Session Summary
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Recording Access via GC360Flix
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Certificate of Participation
Speakers Board
(Speakers to be announced soon)
Who Should Attend?
Legal, Regulatory Affairs & Compliance Officers in Pharma & Biotech
Clinical Trial, R&D, and IP Counsel
Medical Ethics & Transparency Leaders
Privacy & Data Governance Professionals
Why You Should Attend?
Address real-world pharma regulatory and ethics challenges
Benchmark with global peers and compliance heads
Gain tools, checklists, and frameworks for implementation
Join GC360 Membership for 50+ global virtual roundtables
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