Pragmatism in Practice — Clinical & Regulatory Highlights
Join senior QA leaders, compliance specialists, and regulators for three days of practical insights that transform inspection readiness into a competitive advantage. Stop chasing theoretical perfection and start implementing quality that genuinely works.
Expert-Led Sessions Addressing Your Most Pressing Challenges
Case Analysis of PMDA GCP Inspections
Day 1, 13:30 (30 minutes)
The Japan Society of Quality Assurance (JSQA) is dedicated to improving the quality of clinical trials. JSQA is regularly analysing PMDA GCP inspection finding cases. Through this analysis, the JSQA identified remarkable points in findings, performed root cause analyses, and developed potential CAPAs for prevention of recurrence of similar issues.
Impact of ICH E6(R3) & E8 on the Trial Master File
Day 2, 15.30 (30 minutes)
The third revision of ICH E6 Good Clinical Practice introduces significant developments for trial master files and essential records, aligning guidance with modern, risk-based approaches to records management.
This session will detail primary changes and impacts related to essential records, risk proportionality, data governance, quality management, and computerised systems.
Revision of E6: Insights From European Members Who Helped Draft It
Day 3, 11:00 (60 minutes)
This session will include a concise recap of the key changes before taking a deeper look at risk-based quality management, sponsor oversight, and data governance. It will also explore the new Annex 2, addressing novel technologies and trial types, alongside other areas that continue to generate discussion and uncertainty. Featuring Peter Twomey (Head of Inspections at the EMA).
Why Attend the Clinical and Regulatory Sessions?
Be inspection-ready before guidance shifts
Gain direct insight from regulatory professionals on current focus areas and practical mitigation strategies. Our sessions prioritise actionable approaches over theoretical compliance ideals.
Compare EU, Japan, and global perspectives.
Quality and regulatory expectations don’t look the same everywhere. What satisfies inspectors in one region may create gaps in another — and global organisations need to be ready for both.
Practical TMF compliance takeaways.
Compare your quality approaches with peers across pharmaceuticals, CROs, and related industries. Identify where you're ahead—and where targeted improvements will yield the greatest benefit.
Connect with Industry Leaders
The RQA conference offers unparalleled networking opportunities with senior decision-makers who face the same challenges you do. Move beyond theoretical discussions to practical problem-solving with peers who understand your regulatory landscape.
Welcome Reception
Begin forging valuable connections from day one at our exclusive Welcome Reception. Meet speakers, regulators and fellow attendees in a relaxed environment designed to facilitate meaningful conversation.
VIP Networking Sessions
Participate in structured networking roundtables focused on specific compliance challenges. These facilitated discussions ensure you connect with precisely the right people to address your most pressing concerns.
Evening Socials
Continue conversations in a more informal setting at our evening social events. These gatherings have historically sparked collaborative initiatives and valuable professional relationships that extend far beyond the conference.
Who You'll Meet
The RQA conference attracts a diverse yet focused group of professionals responsible for quality assurance and regulatory compliance across pharmaceutical companies, CROs, biotechnology firms, and regulatory bodies.
2024 RQA Conference Attendees Per Continent
Quality Assurance Directors
Senior QA leaders responsible for organisational quality strategy, inspection readiness, and regulatory relationships. Connect with peers facing similar strategic challenges and resource constraints.
Compliance Specialists
Professionals tasked with implementing GxP compliance programmes and preparing for regulatory inspections. Exchange practical approaches to maintaining compliance without operational disruption.
Regulatory Professionals
Representatives from regulatory bodies and professionals managing regulatory affairs within organisations. Gain insight into evolving regulatory expectations and interpretation of guidelines.
Auditors
Internal and external auditors seeking to enhance their audit approaches and effectiveness. Discover methods to add genuine value through the audit process rather than simply identifying deficiencies.
Secure Your Place Today
Attendance at the conference is limited to ensure meaningful interaction with speakers and fellow delegates.
Maximum Delegates
Limited places to ensure quality discussions and networking opportunities
Expert Speakers
Senior practitioners and regulators with proven practical experience
Satisfaction Rate
Previous attendees who would recommend to colleagues
Have questions? Contact our team at conferences@therqa.com.
Quality That Works: Pragmatism Over Perfection