About Event Why you should join QRM Summit?
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
Great Speakers
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.
01All About New
New 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.
02Networking
Meet interesting people, share knowledge and dive in productive conversations in a networking-friendly environment.
Sunny & Warm Lisbon
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.
04Listen to the Scientific Organizing Committee
Ajaz Hussain, PhD
Independent Consultant
Former Deputy Director, OPS/CDER FDA
Dr. Ajaz Hussain
Independent ConsultantFormer Deputy Director, OPS/CDER FDA
Sessions by Dr. Ajaz Hussain
Day 1
12:30 - 12:45 UTCWelcome & Opening Address
Day 2
12:30 - 13:30 UTCCompliance in the Age of Lockdowns & Disruptions: Different Perspectives on Future Business Continuity. Regulatory Agility & Oversight
António Moreira, PhD
Vice Provost for Academic Affairs
University of Maryland UMBC, USA
Dr. António Moreira
Vice Provost for Academic AffairsUniversity of Maryland UMBC, USA
Sessions by Dr. António Moreira
Day 1
12:30 - 12:45 UTCWelcome & Opening Address
Day 2
13:30 - 14:00 UTCQuality, Safety and Efficacy in the Age of Accelerated Timelines. Perspectives on the Development of Biologics and Vaccines
Joerg M. Gampfer, PhD
VP Development & Technology Services
Aenova Holding GmbH
Dr. Joerg M. Gampfer
VP Development & Technology ServicesAenova Holding GmbH
Sessions by Dr. Joerg M. Gampfer
Day 1
12:30 - 12:45 UTCWelcome & Opening Address
Day 1
13:45 - 14:15 UTCThe Art of Anticipation - why using knowledge is a competitive advantage
José C. Menezes, PhD
Chairman and Founder
4Tune Engineering
Dr. José C. Menezes
Chairman and Founder4Tune Engineering
Sessions by Dr. José C. Menezes
Day 1
12:30 - 12:45 UTCWelcome & Opening Address
Day 1
13:45 - 14:15 UTCAcceleration, Compliance, Uncertainties, Excellence: Lifecycle turns 4.0 too!
Event Speakers and Topics
Dr. Kevin O'Donnell
Market Compliance Manager
Health Products Regulatory Authority
Dr. Kevin O'Donnell
Market Compliance ManagerHealth Products Regulatory Authority
Sessions by Dr. Kevin O'Donnell
Day 1
12:45 - 13:45 UTCA Regulator’s Perspective on Quality Risk Management after 15 years of ICH Q9, and reflections on the role of Knowledge Management
Ajaz Hussain, PhD
Independent Consultant
Former Deputy Director, OPS/CDER FDA
Dr. Ajaz Hussain
Independent ConsultantFormer Deputy Director, OPS/CDER FDA
Sessions by Dr. Ajaz Hussain
Day 1
12.30 - 12.45 amWelcome & Opening Address
Day 2
12.30 - 13.30 pmCompliance in the Age of Lockdowns & Disruptions: Different Perspectives on Future Business Continuity. Regulatory Agility & Oversight
Dr. José C. Menezes
Chairman and Founder
4Tune Engineering
David Robert
Cheif Architecture
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
Sessions by David
Day 1
10.30 - 11.30 amMarketing Matters
Day 1
10.30 - 11.30 amMarketing Matters
Dr. Joey Studts
Bioprocess Development Biologicals
Boehringer Ingelheim Pharma GmbH & Co. KG
Dr. Joey Studts
Bioprocess Development BiologicalsBoehringer Ingelheim Pharma GmbH & Co. KG
Sessions by Dr. Joey Studts
Day 1
14:15 - 14:35 UTCThe Path to Knowledge Management in Building Process Understanding: Uncertainties over Lifecycle
Dr. Ulrike Strauss
Senior Manager DSP
Roche Diagnostics GmbH
Dr. Ulrike Strauss
Senior Manager DSPRoche Diagnostics GmbH
Sessions by Dr. Ulrike Strauss
Day 1
Revisiting the Manufacturability Concept of a Commercial Product: Process Characterization Studies and Scale-Down Strategies to Support Continuous Improvement
Ricardo J. Leandro
Head of QRM & Co-Workers
4Tune Engineering
Ricardo J. Leandro
Head of QRM & Co-Workers4Tune Engineering
Sessions by Ricardo
Day 1
15:30 - 15:30 UTCRisk-based advanced approaches to complex modalities and device-based therapies
Dr. Joerg M. Gampfer
VP Development & Technology Services
Aenova Holding GmbH
David Robert
Cheif Architecture
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
Sessions by David
Day 1
10.30 - 11.30 amMarketing Matters
Day 1
10.30 - 11.30 amMarketing Matters
Dr. Pierre-Marie Ebers
Head of Quality Management Systems
Biopharma, Merck Group KGa
Dr. Pierre-Marie Ebers
Head of Quality Management SystemsBiopharma, Merck Group KGa
Sessions by Dr. Pierre-Marie Ebers
Day 1
14:15 - 14:45 UTCIntegrating QRM in the Pursuit of PQS Excellence
To be confirmed
To be confirmed
To be Confirmed
To be Confirmed
Sessions by
Day 1
Dr. Lucy Cabral
Global Head of Supplier Quality and Product Validity
Roche-Genentech Group
Dr. Lucy Cabral
Global Head of Supplier Quality and Product ValidityRoche-Genentech Group
Sessions by Dr. Lucy Cabral
Day 1
15:30 - 16:00 UTCRisk Management of Suppliers and Materials for Biologics and Small Molecule Products
Dr. Jinpian Diao
Global Head of BioProcess Engineering
Sanofi
Dr. Jinpian Diao
Global Head of BioProcess EngineeringSanofi
Sessions by Dr. Jinpian Diao
Day 2
13:30 - 14:00 UTCDigital plant modelling as a way to accelerate and de-risk tech transfers
Hervé Gressard
Head Global Project Statistics CMC Technical R&D
GSK
Hervé Gressard
Head Global Project Statistics CMC Technical R&DGSK
Sessions by Hervé Gressard
Day 2
14:00 - 14:30 UTCImplementation of iRISK in GSK R&D Vaccines
Dr. Francisca Gouveia
Senior Process Expert, MS&T
Novartis BioProduction Operations Huningue
Dr. Francisca Gouveia
Senior Process Expert, MS&TNovartis BioProduction Operations Huningue
Sessions by Dr. Francisca Gouveia
Day 2
14:45 - 15:15 UTCDigital transformation in biomanufacturing: a risk and compliance perspective
Sandra D. Silva
Head of Data Sciences & Co-Workers
4Tune Engineering
Sandra D. Silva
Head of Data Sciences & Co-Workers4Tune Engineering
Sessions by Sandra
Day 2
15:15 - 15:30 UTCEvidence + Knowledge: Combining data-driven Attribute Science with risk-based management of critical assets
Dr. António Moreira
Vice Provost for Academic Affairs
University of Maryland UMBC, USA
David Robert
Cheif Architecture
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
Sessions by David
Day 1
10.30 - 11.30 amMarketing Matters
Day 1
10.30 - 11.30 amMarketing Matters
Dr. Iris Ziegler
Director Development, Business Development & Production
Corden Pharma
Dr. Iris Ziegler
Director Development, Business Development & ProductionCorden Pharma
Sessions by Dr. Iris Ziegler
Day 2
14:00 - 14:30 UTCA case study of QRM in R&D - a systematic approach
Dr. Audrey Schwebel
Risk & Consumer voice Global QA manager
P&G Health International
Dr. Audrey Schwebel
Cheif ArchitectureP&G Health International
Sessions by Dr. Audrey Schwebel
Day 2
14:45 - 15:15 UTCCase-study: How to implement QRM in a global organization to enable Quality Oversight
Dr. Stefan Yohe
Principal Materials Science Engineer
Genentech, A Member of the Roche Group
Dr. Stefan Yohe
Principal Materials Science EngineerGenentech, A Member of the Roche Group
Sessions by Dr. Stefan Yohe
Day 2
15:15 - 15:45 UTCAdvancing the Roche Raw Material Understanding and Variability Control Strategy
LIVE THE EXPERIENCE Enter the discussions & be part of the 4.0 Industry transformation
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 UTCQRM SUMMIT StoryLine QRM Summit By Year
1st 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
Location Stay Tuned
