Program
08:00
Registration
08:50-09:00
Conference Opening & Welcome
Johann Daniel Weyer, ICRC-Weyer GmbH | Conference Chair
09:00-10:30
Session 1: Sponsor Oversight
09:00-09:25
GCP Requirements for Sponsor Quality Oversight - News or Old News?
09:25-09:50
Sponsor Oversight from a Manufacturing POV
Rivka Zaibel
President & Founder ADRES, Advanced Regulatory Services, Israel
09:50-10:15
Sponsor Oversight from the Clinical Perspective
Christoph Ortland
Founder & CEO, Forschungsdock CRO, Germany
10:15-10:30
Discussion / Q&A
10:30-11:00
Coffee Break, Networking & Visit the Exhibition
11:00-12:30
Session 2: Quality Assurance Outsourcing
11:00-11:25
Outsourcing Oversight – Possible or Not?
Christoph Ortland
Founder & CEO, Forschungsdock CRO, Germany
11:25-11:50
Electronic Signatures in Remote Quality Processes
Christian Lange
Quality Assurance Manager, biosafety4u.berlin GmbH, Germany
11:50-12:30
Panel Discussion – What to Outsource When? (and to Whom?)
12:30-13:30
Lunch Break, Networking & Visit the Exhibition
13:30-15:00
Session 3: More Than Following SOPs and Filling QC Forms: Process Owners and QM
13:30-14:00
Assuring Quality in Digital DCTs (DDCTs)
Caroline Schmidt-Lucke
CEO of MEDIACC, Germany
14:00-14:30
Quality Practiced in the Hygiene Environment
Bettina Ernst
Head of QM at Pitzek Consulting, Germany
14:30-15:00
TBD
15:00-15:30
Coffee Break, Networking & Visit the Exhibition
15:30-17:00
Session 4: The Human Factor in Continuous Improvement: Training & Communication
15:30-16:00
What to Do When (Re)training Fails? What are the Options?
Vanessa Hyde
Senior Scientific Expert & Auditor, regenold, Ireland
16:00-16:30
How Training is NOT the Right Solution for Everything
Rivka Zaibel
President & Founder ADRES, Advanced Regulatory Services, Israel
16:30-17:00
TBD
17:00
End of Day One
08:30
Registration
09:00-10:30
Session 5: Risk Assessment & Management
09:00-09:30
Risk Management in DCTs: Elevating Vendor Oversight with ICH E6 GCP R3
Tom Lazenby
Founder & CEO, Mayet Solutions, UK
09:30-10:00
Combining Knowledge - Assessing and Managing Risks for Startups
Johann Daniel Weyer
Partner & Managing Director, ICRC-Weyer, Germany
10:00-10:30
TBD
10:30-11:00
Coffee Break, Networking & Visit the Exhibition
11:00-12:30
Session 6: Vendor Selection, Qualification & Audits
11:00-11:30
Building a Toolbox - Opportunities & Challenges of Systematic Vendor (Pre)Qualification, a Case Study
Joachin Kind
Director Biostatistics & Data Management, ICRC-Weyer, Germany
11:30-12:00
Total Cost of Risk for Outsourcing
Tom Lazenby
Founder & CEO, Mayet Solutions, UK
12:00-12:30
TBD
12:30-13:30
Lunch Break, Networking & Visit the Exhibition
13:30-15:00
Session 7: Audits & Inspections
13:30-14:00
Pre-Approval Inspection - How to Ensure your Vendors are Up for it?
14:00-14:30
Assessing and Maintaining Quality in Complicated Contractual Constellations
Vanessa Hyde
Senior Scientific Expert & Auditor, regenold, Ireland
14:30-15:00
Panel Discussion - Differences and Developments
15:00-15:30
Coffee Break, Networking & Visit the Exhibition
15:30-16:20
Session 8: System Validation
15:30-16:00
Software Validation on the Interface between GCP & GMP
Nimer Yusef
CEO of GxP Brain, Germany
16:00-16:30
TBD
16:30
Closing Remarks & End of Conference
Johann Daniel Weyer, ICRC-Weyer GmbH | Conference Chair
