This annual summit is gaining reputation by creating a pleasant, yet productive environment for the discussion of topics related to Risk and Lifecycle Management on Pharma and Biopharma Operations
Get up to date with all about the future of the industry and discuss the challenges and innovations with highly qualified speakers from all around the globe.
01New challenges, new approaches, new solutions! Be ready with the latest news on Risk Management and find out what’s yet to come in Pharma and Biopharma Operations.
02
Meet interesting people, share knowledge and dive in productive conversations in a networking-friendly environment.
Enjoy sunny and warm Lisbon and all the historic places, picturesque streets and tasty traditions. All of this combined in a cosmopolitan city with a lot to offer during your stay.
04
Independent Consultant
Former Deputy Director, OPS/CDER FDA
Former Deputy Director, OPS/CDER FDA
Welcome & Opening Address
Compliance in the Age of Lockdowns & Disruptions: Different Perspectives on Future Business Continuity. Regulatory Agility & Oversight
Vice Provost for Academic Affairs
University of Maryland UMBC, USA
University of Maryland UMBC, USA
Welcome & Opening Address
Quality, Safety and Efficacy in the Age of Accelerated Timelines. Perspectives on the Development of Biologics and Vaccines
VP Development & Technology Services
Aenova Holding GmbH
Aenova Holding GmbH
Welcome & Opening Address
The Art of Anticipation - why using knowledge is a competitive advantage
Chairman and Founder
4Tune Engineering
4Tune Engineering
Welcome & Opening Address
Acceleration, Compliance, Uncertainties, Excellence: Lifecycle turns 4.0 too!
Market Compliance Manager
Health Products Regulatory Authority
Health Products Regulatory Authority
A Regulator’s Perspective on Quality Risk Management after 15 years of ICH Q9, and reflections on the role of Knowledge Management
Independent Consultant
Former Deputy Director, OPS/CDER FDA
Former Deputy Director, OPS/CDER FDA
Welcome & Opening Address
Compliance in the Age of Lockdowns & Disruptions: Different Perspectives on Future Business Continuity. Regulatory Agility & Oversight
Chairman and Founder
4Tune Engineering
World is committed to making participation in the event a harass ment free experience for everyone, regardless of level experience gender, gender identity and expression
Marketing Matters
Marketing Matters
Bioprocess Development Biologicals
Boehringer Ingelheim Pharma GmbH & Co. KG
Boehringer Ingelheim Pharma GmbH & Co. KG
The Path to Knowledge Management in Building Process Understanding: Uncertainties over Lifecycle
Senior Manager DSP
Roche Diagnostics GmbH
Roche Diagnostics GmbH
Revisiting the Manufacturability Concept of a Commercial Product: Process Characterization Studies and Scale-Down Strategies to Support Continuous Improvement
Head of QRM & Co-Workers
4Tune Engineering
4Tune Engineering
Risk-based advanced approaches to complex modalities and device-based therapies
VP Development & Technology Services
Aenova Holding GmbH
World is committed to making participation in the event a harass ment free experience for everyone, regardless of level experience gender, gender identity and expression
Marketing Matters
Marketing Matters
Head of Quality Management Systems
Biopharma, Merck Group KGa
Biopharma, Merck Group KGa
Integrating QRM in the Pursuit of PQS Excellence
To be confirmed
Global Head of Supplier Quality and Product Validity
Roche-Genentech Group
Roche-Genentech Group
Risk Management of Suppliers and Materials for Biologics and Small Molecule Products
Global Head of BioProcess Engineering
Sanofi
Sanofi
Digital plant modelling as a way to accelerate and de-risk tech transfers
Head Global Project Statistics CMC Technical R&D
GSK
GSK
Implementation of iRISK in GSK R&D Vaccines
Senior Process Expert, MS&T
Novartis BioProduction Operations Huningue
Novartis BioProduction Operations Huningue
Digital transformation in biomanufacturing: a risk and compliance perspective
Head of Data Sciences & Co-Workers
4Tune Engineering
4Tune Engineering
Evidence + Knowledge: Combining data-driven Attribute Science with risk-based management of critical assets
Vice Provost for Academic Affairs
University of Maryland UMBC, USA
World is committed to making participation in the event a harass ment free experience for everyone, regardless of level experience gender, gender identity and expression
Marketing Matters
Marketing Matters
Director Development, Business Development & Production
Corden Pharma
Corden Pharma
A case study of QRM in R&D - a systematic approach
Risk & Consumer voice Global QA manager
P&G Health International
P&G Health International
Case-study: How to implement QRM in a global organization to enable Quality Oversight
Principal Materials Science Engineer
Genentech, A Member of the Roche Group
Genentech, A Member of the Roche Group
Advancing the Roche Raw Material Understanding and Variability Control Strategy
What is the role of digitalization in Pharma and Biopharma? How can you achieve innovation and improve effectiveness of your manufacturing processes? How can you be ready for the upcoming challenges of Risk and Lifecycle Management? Join us to find the answers.
Agenda 2021 Halfdays | 12:30 - 17:30 UTC1st QRM Summit
QUALITY RISK MANAGEMENT
2nd QRM Summit
QRM OVER THE PrODUCT LIFECYCLE
3rd QRM Summit
RISK & LIFECYCLE MANAGEMENT SUMMIT ON PHARMA AND BIOPHARMA OPERATIONS
4th QRM Summit
RISK & LIFECYCLE MANAGEMENT SUMMIT ON PHARMA AND BIOPHARMA OPERATIONS