#RQA2021 PROGRAMME
PROGRAMME WEDNESDAY 3RD NOVEMBER PLENARY STREAM 09.00
Opening Address Welcome from John Beckstrand, CEO, MasterControl KEYNOTE - Quality by agility - Reflect | Challenge | Innovate
Tim Stiles, RQA Chair John Beckstrand, MasterControl Timothe Menard, Roche
10.30
BREAK
11.00
The Life Sciences Approach to Risk
Stephen Turnock, MasterControl
11.30
Question Time
Yasser Farooq, DSTL
12.30
LUNCH
GOOD CLINICAL PRACTICE (GCP) STREAM 14.00
Revisiting and Restructuring Informed Consent
Hugh Davies - Oxford, A NHS Research Ethics Committee
14.30
Remote Data Source Verification in Pandemics Time - A GDPR Compliant Approach
Maurizio Cuocolo and Ivan Tosco, SIMef GIQAR - data Protection Group
15.00
The Rising of Remote GCP Inspections
Natalia Buchneva, UCB Pharma
PHARMACOVIGILANCE STREAM 14.00
Continuous Pharmacovigilance Quality Oversight with Technology Driven Solutions - A Way Forward
Deepak Bageshwar, APCER Life Sciences
14.30
Agile QA
Andrew Cooper, GSK
15.00
Lessons and Best Practices Learnt From the Pandemic for the Future of PV Audit and Inspection
Michael Bean, Johnson & Johnson
GOOD LABORATORY PRACTICE (GLP) STREAM 14.00
GLP MHRA Presentation
Michael McGuinness, MHRA
14.30
Quality vs Compliance - What are you Assuring?
Michelle Manton, Penman Consulting
15.00
The Role of Continuous Improvement in Quality and Compliance
Shona Ross, Tower Mains
15.30
BREAK
THE FUTURE OF QUALITY STREAM 16.00
Capitalising on the Perfect Storm for Digital Quality Transformation
Fabrizio Maniglio, Sparta
16.30
Real Time Quality Insight: Value Metrics as a Key Driver for Continuious Improvement
Sofia Lange, Veeva
17.00
Agile Intelligent Way of working (AI WOW)
Donna Bradley-Koch - Janssen
PHARMACOVIGILANCE STREAM 16.00
PV QA Clinic; Audit Workshop Q&A
Michael Bean, Johnson & Johnson and Pieter Grotenhuis, The Dutch Health and Youth Care Inspectorate
GOOD LABORATORY PRACTICE (GLP) STREAM 16.00
GLP QA Clinic
17.30
VIRTUAL MEET THE EXHIBITORS EVENT
Peter Connaughton, AstraZeneca, Mark Goodwin, GSK, Lisa Heely, Fera Science Ltd., Cate Ovington, The Knowology
WEDNESDAY 3RD NOVEMBER PLENARY STREAM 18.30
Agile Resilience through COVID-19: Quality Oversight and the Era of Modernized Clinical Trials
Sameera Ibrahim, Bristol-Myers Squibb, Dagmar Goertz, Johnson & Johnson, Jonathan Rowell, Johnson & Johnson and Jamila Joseph, IQVIA
19.30
Vendors Input into Computer System Validation
Anna Petrovskaya, Flex Databases
20.00
Challenges Towards Adopting a Risk based Approach for GLP Audits: An Update on OECD GLP Consensus Document No.4
Anand Pandya, JDM Scientific Research Organisation Pvt. Ltd
20.30
Implementing Quality by Design in Pharmacovigilance Quality Audits with Technology Driven Solutions
Pradeep Manglani, APCER Life Sciences
THURSDAY 4TH NOVEMBER AUDITING SKILLS STREAM 07.00
The Auditor-Auditee Relationship and Attributes of an Effective QA Auditor
Labhu Sanghani, Jai Research Foundation
07.30
Practicing an Agile Approach in Auditing
Anand Pandya, JDM Scientific Research Organisation Pvt. Ltd
08.00
Adapting Trial Monitoring in Times of Covid-19: Case Study of an CTIMP Recruiting in LMIC Region
Nabila Youssouf, LSHTM/BHP
INDUSTRY INSIGHTS STREAM 07.00
Ensure Agility for Virtual Pharmacovigilance Inspections Management With Anytime Inspection Readiness (AIR) Synergised by Technology and Automation
Gaurav Shah, APCER Life Sciences
07.30
GLP Compliance for In-Vitro Studies: Challenges and Solutions
Smit Patel, Jai Research Foundation
08.00
Remote GLP Auditing as a Response to Covid 19
Maria Zaytseva, Cromos Pharma
08.30
BREAK
ICH - PLENARY 09.00
ICH Q9 Quality Risk Management Revision: Background and Timelines, Proposed ICH Q9 Updates, What Does it Mean for us?
Glene Sandom, Bristol Myers Squibb
09.45
ICH E6 R3 Update and Potential Impact on Industry
Rebecca Stanbrook, Novartis
10.30
BREAK
INDUSTRY INSIGHTS 11.00
Open Source Code Sharing to Facilitate Cross Industry Collaboration for the Development of Quality Analytical Tools
Bjoern Koneswarakantha, Roche
11.30
GxP Training Effectiveness in a Unified and Connected Quality System
Robert Gaertner and Graham O’Keefe, Veeva
12.00
Safeguard Your Supply Chain: Practical Insights for Remote and Risk-Based Audits
Zillery Fortner, Sparta Systems
PHARMACOVIGILANCE STREAM 11.00
Digitalisation and Pharmacovigilance
Zeynap Yardimici, Novo Nordisk
11.30
Digital MR
Ana Aguirre-Arteta, Novartis
12.00
Compliance and Digital PV
Valentina Mancini, Shionogi Europe
11.00
Living Documentation Within the Software Development for Computerised GxP Systems
Oliver Herrmann, QFINITY
11.30
Are we Getting Better Quality from Agile?
Barry Mcmanus, Empowerment Quality Engineering Ltd
12.00
Computerised System Audit Decision Tree
Richie Siconolfi, Richard M Siconolfi, LLC
IT STREAM
THURSDAY 4TH NOVEMBER GOOD LABORATORY PRACTICE (GLP) STREAM 11.00
Thrown in at the deep end… becoming your facility’s QA Lead
Josee-Ann Dulude and Stéphanie René, Charles River Laboratories
11.30
Qualification of a Vendor Providing a Cloud Based Technology in GLP
Catherine Liang, Charles River Laboratories and Patric Burkhardt, Roche
12.00
Realise the Power of Data Visualisation
Magda Karas and Maria Chalkia, Labcorp Drug Development
12.30
LUNCH
GOOD CLINICAL PRACTICE (GCP) STREAM 14.00
Impact of Covid-19 on the Quality of Clinical Research
Jamila Joseph, IQVIA
14.30
Risk Management and QTLs
Andy Lawton, Risk Based Approach
PHARMACOVIGILANCE STREAM 14.00
MR and PSP Digital Tools Workshop
Ana Aguirre-Arteta, Novartis, Rina Patel, GSK, Sandra Dunlavy, Astellas Pharma Europe BV
14.00
Continuous Validation - Can Modern Software Engineering Techniques Provide Better Control Than Traditional Approaches?
Hugh O’Neill, Pharmaseal International Ltd
14.30
How to Validate AI Algorithms in the Real World
Joanne Donald and Chris Ganter, Roche
15.00
Electronic Data Management After Decommissioning of Computerised System
Anand Pandya, JDM Scientific Research Organisation Pvt. Ltd and Swati Gondhalekar, GPC India Pvt Ltd
IT STREAM
ANIMAL AND VETERINARY PRODUCTS STREAM 14.00
Planned Deviations - Let’s Talk About That
15.30
BREAK
Marci Murphy - MSD Animal Health
GOOD CLINICAL PRACTICE (GCP) STREAM 16.00
eSource Pathways
Rosemarie Corrigan, Nordic Nanovector
16.00
GCP QA Clinic
Fatemeh Jami, AstraZeneca and Piran Sucindran, Invicro
PHARMACOVIGILANCE STREAM 16.00
Pharmacovigilance Inspections - Quality Through Intelligent Risk Assessment
Pieter Grotenhuis, The Dutch Health and Youth Care Inspectorate
16.30
REMS
Liz Nulton-Bodiford, GSK
17.00
Capture Product Complaint and Adverse Events Using Vigilance Collect
Updesh Dosanjh, IQVIA
IT QA Clinic
Joanne Donald, Roche, Sarah Pickersgill, Celerion and Hans de Raad, OpenNovations
IT STREAM 16.00
ANIMAL AND VETERINARY PRODUCTS 16.00
Sponsors vs CRO’s; Will There be Consistency?
Sven Buckingham, Buckingham QA Consultancy,Steve Rogers, Zoetis, Maryna Cronje, MSD Animal Health, Justin Pieterse, Clinvet
17.30
QUALITY QUIZ
LONG TERM READABILITY AND GXP COMPLIANCE SESSION 18.30
Compliance Auditors Perspective: Digital Data Challenges and Non-compliance with ALCOA+ Requirements
TBC
19.00
Implementation of the OECD/MHRA guidance on legacy Natasa Milic-Frayling, Intact Digital software management in virtual environments
19.30
BREAK
19.45
Expert Roundtable - Discussing new processes and practices in managing legacy software and colloboration with technology vendors to remove obstacles for achieving required longevity of research data and reliable validation of research studies
Julien Davies, LGC, Julien Marchand - Ferring, Natasa Milic-Frayling, Intact Digital
FRIDAY 5TH NOVEMBER THE FUTURE OF QUALITY STREAM 09.00
Basis of GLP Study Rejection: A Regulatory Perspective
Anand Pandya, JDM Scientific Research Organisation Pvt. Ltd
09.30
Innovation in Transferring Knowledge From Audits and Inspections
Kristel Van de Voorde, Bristol-Myers Squibb
10.00
Bringing an NHS Research Department into the New Norm
Rebecca Wilby, Teaching Hospitals NHS Foundation Trust, Lancashire
INDUSTRY INSIGHTS STREAM 09.00
The Link Between Data Integrity and Risk Awareness and Risk Management
Willi Ramseier, QVRAM GmbH
09.30
Digital Transformation in Life Sciences for Industry 4.0 and the Cost of Quality to Your Organisation
Paul Quinn, IQVIA
10.00
Approving Records in a Compliant Way
Aurielie Delaunay, Merck
10.30 BREAK INDUSTRY INSIGHTS STREAM 1 11.00
Handling of Amendment and Deviation for GLP Compliance
Smit Patel, Jai Research Foundation
11.30
e=mc2 (Education = micro x continuous2)
Cate Ovington, The Knowlogy
12.00
How a Culture of Diversity and Innovation is Driving the Modernisation of R&D Quality
Federico Feldstein, Johnson & Johnson
INDUSTRY INSIGHTS STREAM 2 11.00
Comparison of ISO20916-2019 with ICH GCP Principles
Alessandra Grande, Merck
11.30
A Life Science Paradigm Shift: Ready to Use Quality and Compliance Solutions
Rick Bradley, Dot Compliance
12.00
The Data Centric Road to Better Quality
Rajesh Talpade, MasterControl
12.30
LUNCH
PLENARY STREAM 13.30
MHRA - Inspectors grounded - a year of innovation
14.30
BREAK
Paula Walker, MHRA
PLENARY STREAM CONT. 15.00
Quality Pillars for Real World Data
Jeff Kirsch, Jeff Kirsch Consulting Ltd
15.30
Transcelerate Real World Data Audit Readiness
Lynette Aldrich, Lilly
16.00
Real World Evidence (RWE)
Frank Henrichmann, QFINITY
16.30
Industry Leaders Round Table
Allison Jack, GSK, Theresa Haughey, GSK, Pieter Grotenhuis, The Dutch Health and Youth Care Inspectorate, Lesley Graham, AstraZeneca plus others
17.30
Close of Conference
Tim Stiles, RQA Chair
and... • Lifetime access to videos on RQA’s conference platform • Conference-only discussion forums and live chat • RQA and exhibitor competitions, including the chance to win a place at the 2022 face-to-face conference in Brighton.
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