11.00 Clinical Quality Management System (CQMS) for Operational Excellence & Compliance with GCP - Amer Alghabban

11.30 Death by CAPA - Oleg Shevaldishev

12.00 Modernisation of Clinical Vendor Oversight Through Effective Risk Management Tools - Natalia Buchneva 

12.30 Lunch

14.00 GCP QA Clinic - Piran Sucindran, Fatemeh Jami, Cathy Dove - GCP Committee 

15.30 Break

16.00 The Italian Non-Profit Phase 1 Clinical Trial Units: Present Challenges and Future Opportunities - Davide Di Tonno

16.30 Update on the Regulatory Landscape of Decentralised Trials - Fatemeh Jami

17.00 Privacy and e/Consent - Profiles - Ivan Tosco

 

11.00 How to Leverage Supplier Input in CSA, New Insights from GAMP 5 2nd Edition and Updated ISO 27001 - Hans de Raad

11.30 Where  ICHQ9 (R1) and GAMP5 2e  Meet: Applying risk-based Principles to Maximise Efficiency in CSV - John Cheshire

12.00 Computerised System UAT: Faster and Easier - Anna Petrovskaya

12.30 Lunch

14.00 IT QA Clinic - Use of test tools in CSV - how does this impact the regulatory expectations for documented evidence - Hans de Raad, Nina Häuselmann and Keith Thornley

15.30 Break

16.00 RQA IT Committee - Long-term perspective on digital transformation: Managing risks of digital obsolescence. What are current computing practices and a framework for long-term software care? – Presentations and Expert Roundtable discussion - Nina Häuselmann, Hugh O’Neill, Natasa Milic-Frayling, Richie Siconolfi, Hans de Raad.

16.00 Introduction - Nina Hauselmann

16.10hrs Current Computing Practices - Hugh O’Neill

16.30 A Framework for Long-term Software Care - Natasa Milic-Frayling

16.50 Break

17.00 Expert Roundtable on the management of digital obsolescence. Discussion of digital transformation planning practices and management of software lifecycle. Reflection on the existing and new processes for managing legacy software. Considering ways to remove obstacles for achieving longevity of data and reliable validation of research and studies – Hugh O’Neill, Richie Siconolfi, Hans De Raad, Natasa Milic-Frayling.

Your Health

11.00 Beating Stress at Work, Helen Moon

12.30 Lunch

Future of Quality

14.00 A Comparison of Criteria used to Define Real World Non-Interventional Studies - Jeffrey Kirsch

14.30 SmartConnected Devices - The Future of MedTech - Prem Iyangar

15.00 Cultivating a Culture of Quality: Transforming your Organisation for the Better - Zillery Fortner

15.30 Break

Animal Health

16.00  The Three Pillars - Quality, Safety & Welfare - Maryna Cronje

16.30 Fit for farm? Does livestock technology fit within a GCPv setting? - Lindsay Heasman

17.00 General Veterinary Q&A- Marci Murphy

09.00 Roles and Responsibilities of GLP QA: OECD Advisory Document No.23 Perspective - Anand Pandya

09.30 Risk-Based Assessment is a Novel QA Auditing Strategy - Hemangini Patel

10.00 Challenges to QA in the Era of Electronic Data - Smit Patel 

10.30 Break

11.00 GLP QA Clinic - Cate Ovington, Jane Elliston, Fiona Wilder, Sven Buckingham, Vicky Massie

12.30 Lunch

13.30 The Key to Compliance? - Lisa Heely

14.00 Inspection Hot Topics, Emma Whale, MHRA

15.00 Break

15.30 

15.30hrs OECD 23 Changes and How QA can Address These – Sven Buckingham and Lisa Heeley

Pharmacovigilance:

09.00 How will ICH E-19 Affect PV Practice, Especially in Japan - Teiki Iwaoka

09.30 Assessment of IT Systems For Drug Safety - Shikha Jain

10.00 To Identify Risk Factors Associated with Cybersecurity, Threats for Medical Device Functionality - Shikha Jain 

10.30 Break

11.00 Auditing Automated and Manual Safety Case Processing Systems - Checks and Balances - Graeme Ladds

11.30 Ensuring Compliance Through the Establishment and Functioning of the QPPV Office - Gaurav Shah

12.00 Description of Pharmacovigilance System - Jana Hyankova

12.30 Lunch

GCP:

13.30 Inspection Findings - What can we Learn From Them - How to Analyse the Data to get the Most out of it - Loveleen Kukreja and Milind Nadgouda 

15.00 Break

15.30 Training Compliance and the Emperor's New Clothes - Iain Searle

16.00 Using politeness Theory to Improve Outcomes in Audits and Inspections - Denise Lacey

Future of Quality:

09.00 Answer the Two Most Often and not Expected to be Answered Questions: How to Measure the Quality here and I am Stuck, Not Sure Where to go, What to do - Willi Ramseier

09.30 Technology and Empowering your Company - Carmen Au

10.00 Smart Quality: The New Paradigm - Filip Heitbrink

10.30 Break

11.00 Reflections on a New RQA SIG - Quality Practices for Real World Non-Interventional Studies - Jeffrey Kirsch

11.30How much do we know about Digital Healthcare? - Josipa Ljubicic 

12.00 Quality in Dialogue with Quantification - Suzanne Studinger

12.30 Lunch

Future of Quality:

13.30 3 Steps to Compete in Digital Quality - Kevin Ballard

Regulatory:

14.00 IVD, CDx, LDT (IH-IVD): Challenges of the Current Regulatory Landscape - Alessandra Grande

14.30 Challenges in Chemistry Manufacturing and Controls (CMC) for Innovative Therapies - Rachel Harte

15.00 Break

Future of Quality:

15.30hrs Healthcare Digitalisation – Maria Veleva

17.00 Close of Conference - Tim Stiles, RQA Chair