20/20 VISION - RQA Delegate Brochure

2020 RQA INTERNATIONAL QA CONFERENCE

10th - 12th NOVEMBER 2020

#RQA2020

SPONSORED BY

RQA’S FIRST VIRTUAL CONFERENCE PLENARY SESSIONS

INDUSTRY INSIGHT SESSIONS

FREE EXHIBITION

Q&A AND CHAT

DISCUSSIONS

QA CLINICS

SCIENTIFIC POSTER DISPLAY

INTERACTIVE, VIRTUAL EXHIBTION

NETWORKING EVENTS

PROGRAMME COMMITTEE CHAIR, ALLISON JACK: “The theme for this year’s International Conference is 20/20 Vison - A New Frontier?

When the conference programme committee started to plan for this year’s conference we wanted it to look and feel different from previous years conferences and embrace new ways to present and deliver the conference. We wanted the conference theme to reflect that we need to have a new vision to what quality would look like in a world that is changing in particular with the rapid advances in new technology.

Little did we know that 2020 would indeed be giving us a new vision for the future and that we would be facing a new frontier due to the Covid-19 pandemic. We have had the ‘opportunity’ to utilise and embrace new technologies, not only in our daily working lives such as remote auditing, but also on a personal level, to stay connected with one another.

This year’s conference has gone virtual and we are using a new platform to bring the conference to you so that we can stay connected. This international conference will be spanning many time zones to enable our quality colleagues around the world to be with us, by hosting the conference over 15 hours .

As QA professionals we have always had to be adaptable and during these challenging times even more so and have to look at adopting and embracing new ways of auditing and achieving quality is one of the themes coming out of the conference.

”

We invite you to join us and be part of this new frontier.

WHAT WILL I NEED?

BENEFITS NO TRAVEL RESTRICTIONS Access from anywhere you have an internet connection. Limits time out of the office and in the current climate, a virtual conference is the best way to still stay up to date.

GLOBAL The conference will be open for up to 15 hours per day, which means content can be accessed across the timezones. We are adding more to the programme all the time.

MISSED A SESSION? No problem - presentations will be available on demand a few hours after they have been presented and the platform will be live for 30 days after the event. Presentations will then be moved onto the RQA website.

SOME THINGS CHANGE, SOME THINGS DON’T We have ensured that the programme is still reminiscent of a traditional RQA conference - with plenary sessions, GxP focused streams and regulatory input.

LIFETIME ACCESS Presentations will be available on the RQA website for delegates to view at any time.

WHY ATTEND?

A VARIED PROGRAMME

This year’s Programme is made up of streams and new for our virtual format, Industry Insights.

Presentations will be focused on topics such as COVID-19, remote working, international challenges, ATMPs and much more. View the full programme from page 6 to view all the presentations.

REGULATORS IN ATTENDANCE

Regulators will be in attendance from all over Europe, speaking to delegates on a variety of topics and being involved in the popular Regulator’s Roundtable on Thursday afternoon.

THIS YEAR’S SPEAKERS

Speakers will also be drawn from across the world to provide delegates with a wide and varied experience. We have confirmed speakers from the UK, USA, India, Russia and more, from big pharma and small consultancies all with a wealth of experience in their field.

TOPICAL STREAMS

Streams cover the GxPs as is usual at an RQA conference. This year we have focused sessions on IT, PV, GCP, GLP and GMP as well as interactive QA Clinics for IT, PV, GCP, GMP and GLP.

NETWORK, NETWORK, NETWORK

The conference will be a great opportunity for networking with like-minded colleagues – from virtual breaks and dicussions to QA Clinics and social events, there will be ample opportunity to catch up with previous acquaintances and make new ones. You will have the ability to chat with fellow attendees throughout the event.

EXHIBTION HALL

A large exhibition area will allow delegates to network with up to 40 suppliers and recruitment agencies.

Unlike a physical event, you can go into the Exhibition Hall whenever you choose and can download information into your virtual briefcase to read at a later date.

VIRTUAL

BOOK NOW

Virtual conferences have many positives over a physical event, from cost to experience. It’s easy to take part and meet people, or just participate as an individual. Virtual events give you the freedom to move around the sessions at your choosing and download information for viewing at another time. See the infographic on page 5 for more.

A VIRTUAL VENUE AVAILABLE ACROSS THE TIME ZONES The virtual event will run across time zones, so no matter where you are you can get involved. If you miss a presentation it will be available as on-demand within hours.

EVERGREEN CONTENT The virtual conference platform will be available for 30 days after the event and after that we will publish content to our website, so delegates always have access to presentations.

INTERACTIVE Virtual events are interactive in a way a physical event could never offer. Not only can delegates freely move around presentations and have access to them on-demand almost instantly, but you can easily access a vast amount of information from industry experts, from your desk.

NETWORKING INFORMATION We are working hard to ensure that delegates can network as well as ever before and will be arranging events throughout the conference to keep everyone as engaged and involved as possible.

QUESTION TIME QA Clinics in all GxPs running where delegates can ask their burning questions and have them discussed with speakers, each live session will have a live Q&A with speakers and polls to rank the most popular.

MEET THE EXHIBITORS Virtual exhibtion stands are extremely interactive, exhibitors can chat with you 1:1 and provide you with loads of information to download and read in your own time. We will also have exhibitor competitions so you have the chance of winning prizes.

THE PROGRAMME TUESDAY 10TH NOVEMBER PLENARY STREAM:

09.00 OPENING ADDRESS, Tim Stiles, RQA Chair

All times are listed in GMT

09.15 KEYNOTE SPEAKER, Kriss Akabusi, The Akabusi Company 10.30 Networking Break 11.00 COVID-19 GXP INSIGHTS/CONCLUSIONS, Dave Nickerson, Richard Crossland, Stuart Pullen, Joanne Donald and Steve Rogers 12.30 Networking Break and Lunch

NOW YOU CHOOSE: STREAM ONE: THE FUTURE OF QUALITY

STREAM TWO: INDUSTRY INSIGHTS

STREAM THREE: IT

14.00 THE MULTICULTURAL AUDITOR Andrew Waddell, Tower Mains

HOW LONG SHOULD AN EFFECTIVE AUDIT TAKE? Christine Henderson

QUALITY DATA ANALYTICS: GETTING STARTED, OPTIMISING UNDERSTANDING, AND CROSS-COMPANY SHARING Timothe Menard, F. Hoffmann - La Roche Ltd and Jennifer Emerson, Boehringer Ingelheim

Stephen McCarthy, Sparta Systems

QUALITY IN RESEARCH: A FIT FOR PURPOSE APPROACH Alessandra Grande, Merck

AI: VALIDATION CHALLENGES TBC

15.00 QA OF THE FUTURE: INDUSTRY THINKTANK OUTCOME Sharmila Sabaratnam, Ernst & Young​​​​​​​

QUALITY ASSURANCE SYSTEM IN RUSSIA Maria Flerova, LLC STPF POLYSAN

15.30 Networking Break

15.30 Networking Break

13.30 TRANSFORMING QUALITY FOR 2020 AND BEYOND Robert Gaertner, Veeva Vault Quality

14.30 INDUSTRY 4.0 AND THE TOTAL COST OF QUALITY

16.00 THIRD PARTY RISK MANAGEMENT FROM SELECTION TO TERMINATION/RENEWAL Oliver Steck, Deloitte & Touche LLP

RISK BASED AUDITING - DEVELOPING A QA AUDIT STRATEGY AND EXECUTION PLAN Milind Nadgouda, RiverArk Limited

AI: ARE WE READY FOR THE AI REVOLUTION Richard Brown, ADAMAS Consulting 15.30 Networking Break CSA CRITICAL THINKING Oliver Hermann, QFINITY

TUESDAY 10TH NOVEMBER cont...

STREAM ONE: THE FUTURE OF QUALITY

STREAM TWO: INDUSTRY INSIGHTS

STREAM THREE: IT

INTRODUCTION TO BLOCKCHAIN AND AN EARLY LOOK INTO SOME PROMISING USE CASES IN PHARMA Scott Askin, Novartis

CLOUD BENEFITS IN LIFE SCIENCES David Blewitt, USDM Life Sciences

SETTING UP BACK OFFICE OPERATION IN INDIA TO SUPPORT GLOBAL CLINICAL TRIALS Marian Mutch, Covance

IT QA CLINIC

17.30 Networking Event

17.30 Networking Event

17.30 Networking Event

INDUSTRY INSIGHTS

INDUSTRY INSIGHTS

INDUSTRY INSIGHTS

THE BASIC QUALITY MANAGEMENT SYSTEM FOR PV PROCESSES REQUIRED IN THE EU Laurence Richard, Audithem

PROVIDING QUALITY ASSURANCE WITH EVERCHANGING TECHNOLOGY Milind Nadgouda and Yogesh Agarwal, RiverArk Limited

AGILE DEVELOPMENT FOR CLINICAL RESEARCH SYSTEMS Alan Yeomans, Viedoc Technologies (formerly PCG Solutions)

PROVIDING QUALITY ASSURANCE WITH EVERCHANGING TECHNOLOGY

16.30 QUALITY BEYOND COMPLIANCE Sue Marchant, MasterControl Inc.

17.00 OPTIMISING TRIAL DESIGN AND RISK-BASED OVERSIGHT THROUGH QUALITY BY DESIGN Ann Meeker O’Connell, Vertex Pharmaceuticals

18.30 WHO’S ON FIRST: DEVELOPING THE BEST INSPECTION TEAM Kara Harrison, FDA Quality + Regulatory Consultants 19.00 DUE DILIGENCE IN VENDOR SELECTION Chris Rush FDA Quality + Regulatory Consultants 19.30 OFF ROADING REMOTE AUDIT COMMUNICATION AND PLANNING Erich Zirzow, FDA Quality + Regulatory Consultants 20.00 AUDITING TECHNIQUES FOR CAUSE/DIRECTED AUDITS Tammy Lesko, FDA Quality + Regulatory Consultants 20.30 METRICS THAT MATTER Michelle Copeland, FDA Quality + Regulatory Consultants

HOW TO MAKE SURE THE QUALITY IS AS IT SHOULD BE OR WHERE DOES TRUST COME IN WHEN YOUR NAME IS AT STAKE? Willi Ramsier, QVRAM GmbH IMPROVEMENT OF THE INTERNAL AUDIT TASK SELECTION PROCESS - PRIORITY CHECKS USING RISK SCORING TOOLS Sooyeon Yang, AMC HOW TO WRITE A VALIDATION OR QUALITY ASSURANCE PLAN – TO BE ABLE TO TRUST THE OUTCOME AND SIGN THE REPORT Willi Ramsier, QVRAM GmbH

OFFER Book the conference, together with one of our courses and get 20% off delegate fees.

Use code: CONCRS20

WEDNESDAY 11TH NOVEMBER STREAM ONE: INDUSTRY INSIGHTS

07.30 MANAGEMENT OF MULTI SITE STUDIES - CHALLENGES AND SOLUTIONS Labhu Sanghani, Jai Research Foundation 08.00 OUTSOURCING OF NON CLINICAL STUDIES: ENSURING QUALITY AND COMPLIANCE FOR CARE, HOUSING AND CONTAINMENT OF BIOLOGICAL TEST SYSTEM Labhu Sanghani, Jai Research Foundation 08.30 DO ANALYSTS REQUIRE QUALITY ASSURANCE? FROM A GLP PERSPECTIVE Smit Patel, Jai Research Foundation

65+ PRESENTATIONS

SPEAKERS FROM 10+ NATIONALITIES

FIVE GXP SPECIFIC QA CLINICS

56% OF SPEAKERS ARE NEW TO RQA

STREAM TWO: INDUSTRY INSIGHTS 07.30 PREVALENCE OF A QUALITY CULTURE DRIVING DATA INTEGRITY- A GMP VS GLP PERSPECTIVE, Joyce KO 08.00 FUNDAMENTAL CONSIDERATIONS IN THE RESEARCH AND CLINICAL RESEARCH LABORATORY Louise Mawer, Mirabilitas and Lucy Saunderson, Headway Quality Evolution

STREAM THREE: INDUSTRY INSIGHTS 07.30 GXPS IN THE ADVANCED THERAPY MEDICINAL PRODUCT (ATMP) WORLD Marc Kemp and Eveline Krijger

WEDNESDAY 11TH NOVEMBER cont...

STREAM ONE: GOOD CLINICAL PRACTICE

STREAM TWO: GOOD LABORATORY PRACTICE

STREAM THREE: PHARMACOVIGILANCE

09.30 HINDSIGHT: IMPACT OF DI GUIDANCE TBC

REMOTE PRECLINICAL AUDIT – IS IT RIGHT FOR ME?

10.00 HINDSIGHT: EMA TMF GUIDANCE TBC

UPDATE ON EU MEDICAL DEVICES – IMPACT ON PHARMACOVIGILANCE Aya Souka, GSK

SPONSOR OVERSIGHT OF GLP THIRD PARTIES Michelle Manton, Penman Consulting

INSPECTIONS OF NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDIES Kiernan Trevett, MHRA

10.30 Networking break

10.30 Networking break

10.30 Networking break

RESPONDING TO AUDIT REPORTS Sven Buckingham, Buckingham QA Consultancy and Peter Connaughton, AstraZeneca

LICENSING PARTNER RISK ASSESSMENT – WHERE TO NOW? Andrew Cooper, GSK

RESPONDING TO AUDIT REPORTS

REMOTE PHARMACOVIGILANCE AUDITS Wumi McDowall, Seqirus

12.00 HERE AND NOW: EXPERIENCE OF OFFICE BASED INSPECTIONS Anita Hawkins, GSK

RESPONDING TO AUDIT REPORTS

MARKETING PARTNER PV AUDIT OPTIMISATION Jonathan Rowell, Janssen Pharmaceutical Companies

12.30 Networking break and lunch

12.30 Networking break and lunch

09.00 HINDSIGHT: THE IMPORTANCE OF QTLS TO CLINICAL DEVELOPMENT William Lawton, Risk Based Approach Ltd

11.00 HERE AND NOW: REMOTE AUDITING Cathy Dove, Dove Quality Solutions 11.30 HERE AND NOW: VENDOR QUALITY MANAGEMENT Hanna Preus, Opiant Pharmaceuticals

09.00 REMOTE PRECLINICAL AUDIT – IS IT RIGHT FOR ME? Paul Davidson, Headway Quality Evolution

09.00 LESSONS LEARNED FROM MANAGING REMOTE INSPECTIONS David Lewis, Novartis

12.30 Networking break and lunch

QUIZ NIGHT Join us at 17.30 (GMT) for a virtual quiz night on Wednesday 11th November.

Prizes to be won and a fun way to network with piers.

WEDNESDAY 11TH NOVEMBER cont...

STREAM ONE: GOOD CLINICAL PRACTICE

STREAM TWO: GOOD LABORATORY PRACTICE

STREAM THREE: PHARMACOVIGILANCE

14.00 FUTURE SHOCK: IMPACT ASSESSMENT OF ICH RENOVATION Kerstin Koenig, Merck and Rebecca Stanbrook, Novartis

LABORATORY STANDARDS: TESTING IN A PANDEMIC Louise Handy, Handy Consulting Ltd

PV AUTOMATION (TRANSCELERATE) Raymond Kassekert, GSK

14.30 VIRTUAL TRIALS: BRINGING THE TRIAL TO THE PATIENT Fiona Maini

OECD DATA INTEGRITY Andrew Gray, MHRA

QA OF THE FUTURE AND PV AUTOMATION Paul Houri, J&J

15.00 VIRTUAL TRIALS: FUTURE NOW Fatemeh Jami, Medical Research Network Ltd

GCLP: A HYBRID OF GLP AND GCP Mark Goodwin, GSK

WHAT IS THE FUTURE OF QA? Daniel Dodwell, Roche

15.30 Networking break

15.30 Networking break

15.30 Networking break

AUDITING SOFT SKILLS INTERVIEW TECHNIQUES Lesley Graham, AstraZeneca

PHARMACOVIGILANCE QA CLINIC

AUDITING SOFT SKILLS INTERVIEW TECHNIQUES

PHARMACOVIGILANCE QA CLINIC

WHAT IS A DEVIATION?…DEEP THOUGHTS Megan Lawhead, Charles River Laboratories

PHARMACOVIGILANCE QA CLINIC

17.30 QUIZ

17.30 QUIZ

13.30 HERE AND NOW: ELIMINATE SILOS, DRIVE GLOBAL ALIGNMENT ACROSS CLINICAL AND QUALITY, Stijn Willems, Veeva Systems

16.00 GOOD CLINICAL PRACTICE QA CLINIC 16.30 GOOD CLINICAL PRACTICE QA CLINIC 17.00 GOOD CLINICAL PRACTICE QA CLINIC 17.30 QUIZ

INDUSTRY INSIGHTS

INDUSTRY INSIGHTS

18.30 OPPORTUNITIES AND CHALLENGES TO CONDUCTING REMOTE VISITS, Juliet Hulse, Illingworth Research Group

TBC

19.00 WHY IS IT CALLED QMS? THERE WAS NEVER A BETTER TIME FOR A CONTROLLED REASSESS OF YOUR STRATEGIES AND FRAMEWORK (QMS), Willi Ramseier, QVRAM GmbH

MANAGEMENT OF A VIRTUAL QUALITY PROGRAMME Dawn Speidel, Latham Biopharm Group

19.30 BUSINESS RESILIENCE AND EMBRACING TECHNOLOGY DURING COVID 19 – THE GOOD, THE BAD & THE UGLY Milind Nadgouda and Yogesh Agarwal, RiverArk Limited

BUILDING A CULTURE IN YOUR ORGANISATION TO SUSTAIN DI Joe Franchetti, JAF Consulting, Inc

THURSDAY 12TH NOVEMBER STREAM ONE: INDUSTRY INSIGHTS 07.30

08.00 REMOTE AUDITING: A NEW NORMAL? CHALLENGES AND OPPORTUNITIES Marie-Dominique Mompas, VIGLYA S.L. 08.30 TOP OF THE COVID POPS Louise Mawer, Mirabilitas and Mark Poulton, Poulton Quality Solutions

STREAM TWO: INDUSTRY INSIGHTS

STREAM THREE: INDUSTRY INSIGHTS

THE DUTCH COVID APP Brenno de Winter, De Winter Information Solutions and Hans de Raad, OpenNovations

ESTABLISHING A FUTURE PROOFED PLATFORM FOR PROACTIVE QUALITY MANAGEMENT Gary Chambers, SGS

THE DUTCH COVID APP

THE DUTCH COVID APP

GMP MODERNISING PHARMA MANUFACTURING WITH DIGITAL QUALITY MANAGEMENT, Robert Gaertner, Veeva Vault Quality

THURSDAY 12TH NOVEMBER STREAM ONE: INDUSTRY INSIGHTS

STREAM TWO: INDUSTRY INSIGHTS

STREAM THREE: GMP

09.00 THINKING CRITICALLY ABOUT CRITICAL THINKING Coree Forman, Q-STAR Consulting

THE IMPORTANCE OF QUALITY CULTURE IN CLINICAL TRIALS Hanna Preus, Opiant Pharmaceuticals

GMP LEGISLATIVE UPDATE Phil Butson, GSK

TRUST AND TRANSPARENCY - A PERSPECTIVE FROM SOFTWARE-ASA-SERVICE PROVIDER Tony Hewer, Medidata Solutions Inc

GMP QA CLINIC

FACILITATING GCP COMPLIANCE IN PHASE 1 UNITS: THE ITALIAN CASE Antonella Ursini, seQure

GMP QA CLINIC

10.30 Networking break

10.30 Networking break

09.30 KEY TRAINING: THE RECIPE FOR EFFECTIVE, EFFICIENT AND ENGAGING COMPLIANCE TRAINING Erwin de Beuckelaer, Johnson & Johnson 10.00 OPERATIONALISING THE ICH E6 R2 REQUIREMENTS OF QTLs Dagmar Goertz, Janssen-Cilag GmbH 10.30 Networking break

GLP 11.00 THE JOURNEY OF AN AUDIT FINDING Joanne North, Janssen

QA INNOVATIVE APPROACHES DURING COVID19 Katie Whigham and Jolanda Bruggencate

GLP QA CLINIC

11.30 INSPECTION READINESS FOR SPONSORS/CROS USING VENDOR SOFTWARE Alan Yeomans, Viedoc Technologies (formerly PCG Solutions)

ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS): FINDING OUR WAY! Christine Mitchell, ChrisalisQAdvice

GLP QA CLINIC

12.00 THE QUALITY AND COMPLIANCE BENEFITS TO ECONSENT Hannah Glenny, Otsuka Pharmaceutical Development & Commercialization, Inc

REMOTE AUDITS IN PHARMACOVIGILENCE WITH OPTIMUM AUGMENTED INTELLIGENCE Gauravkumar Shah, APCER Life Sciences

GLP QA CLINIC

12.30 Networking break and lunch

12.30 Networking break and lunch

12.30 Networking break and lunch

PLENARY STREAM: 20/20 VISION - A NEW FRONTIER? 14.00 OFFICE BASED INSPECTION STRATEGY, Paula Walker, MHRA and Naoki Tsutsumi, The University of Tokyo 15.00 Networking Break 15.30 REGULATORS/EXPERTS/LEADERS ROUNDTABLE, Andrew Gray, MHRA, Anne Meeker O’Connell, Vertex Pharmaceuticals, Theresa Haughley, GSK, Rebecca Stanbrook, Novartis, Marian Mutch, Covance, Peter Connaughton, AstraZeneca 17.30 CLOSE CONFERENCE, Tim Stiles, RQA Chair

BOOK NOW

2020 RQA INTERNATIONAL QA CONFERENCE

10th - 12th NOVEMBER 2020

WWW.THERQA.COM/CONFERENCES

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