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FULL PROGRAMME

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Wednesday 3rd November 

 

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

PHARMACOVIGILANCE STREAM

GOOD LABORATORY PRACTICE (GLP) STREAM

 

15.30 BREAK

 

THE FUTURE OF QUALITY STREAM

PHARMACOVIGILANCE STREAM

GOOD LABORATORY PRACTICE (GLP) STREAM

 

17.30 VIRTUAL MEET THE EXHIBITORS EVENT

 

18.30

Agile Resilience through COVID-19: Quality Oversight and the Era of Modernised 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

 

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Thursday 4th November 

AUDITING SKILLS STREAM

INDUSTRY INSIGHTS STREAM

 

08.30 BREAK

 

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

PHARMACOVIGILANCE STREAM

IT STREAM

GOOD LABORATORY PRACTICE (GLP) STREAM

 

12.30 LUNCH

 

GOOD CLINICAL PRACTICE (GCP) STREAM

PHARMACOVIGILANCE STREAM

IT STREAM

Animal and Veterinary Products Stream

 

15.30 BREAK

 

GOOD CLINICAL PRACTICE (GCP) STREAM

PHARMACOVIGILANCE STREAM

IT STREAM

Animal and Veterinary Products

 

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 software management in virtual environments  Natasa Milic-Frayling, Intact Digital
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

 

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Friday 5th November 

 

THE FUTURE OF QUALITY STREAM

INDUSTRY INSIGHTS STREAM 1

 

10.30 BREAK

 

INDUSTRY INSIGHTS STREAM 1

INDUSTRY INSIGHTS STREAM 2

 

 

12.30 LUNCH  

13.30

MHRA - Inspectors grounded - a year of innovation

Paula Walker, MHRA

14.30 BREAK  
15.00

Quality Pillars for Real-World Data and Real-World Evidence

Jeff Kirsch, Jeff Kirsch Consulting Ltd
15.30 Transcelerate Real-World Data Audit Readiness Lynette Aldrich, Eli Lilly & Company
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, Paul Houri, Johnson & Johnson
17.30 Close of Conference Tim Stiles, RQA Chair

 

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