'Breaking the ice - exploring the depths of quality' Delegate Brochure

Breaking the ice Exploring the depths of quality RQA International QA Conference 1st - 3rd November 2023, ICC Belfast

DELEGATE brochure PLATINUM SPONSORS

RQA INTERNATIONAL QA CONFERENCE 2023

Conference highlights Join us for an unforgettable experience at the RQA International QA Conference 2023 in the charming city of Belfast. Immerse yourself in cutting-edge discussions and gain valuable insights from industry leaders and regulators. Expand your network and connect with like-minded professionals from around the world.

Don’t miss this opportunity to enhance your skills and knowledge in the field of quality assurance. Book now and be part of the excitement!

This year’s theme is ‘Breaking the ice - exploring the depths of quality’, inspired by the building of the RMS Titanic at the Harland and Wolff shipyard just down the river. The sessions will delve into the intricacies of the quality assurance profession, with Q&A sessions to further dive into specific topics relevant to you.

As part of our 2023 initiative on development routes, the conference programme has been labelled with our three categories: learn, develop, extend.

New to QA stream We recognise that there is a population of delegates who are new to the QA profession and in order to give you access to learning by experienced professionals and others who have recently been in your position we have curated a low cost, New to QA stream within the conference this year.

This stream has been put together specifically for anyone starting out on their QA journey.

Limited to 25 attendees, New to QA will run alongside our standard programme, dipping in for some plenary sessions, but will be more interactive and hands-on than the rest of the conference. It will include presentations, workshops, Q&As and access to a wealth of experience taken from the RQA membership.

The group will be led by RQA members John Cheshire and Robbie Boyle, who have been chosen by the RQA office as they have recently gone through a ‘new to QA’ journey and have shown the knowledge, skills and personalities needed to guide you on your own journey. The group will be encouraged to network preconference, a specific space will be provided during the Meet the Delegates drinks reception and we will facilitate networking throughout.

The New to QA stream will be offered at a discounted rate following previous conference feedback and is available to RQA members only. Booking at this rate does not allow access to the rest of the conference, unless scheduled within the New to QA stream. We have 25 spaces available and these will be sold on a first come, first served basis.

RQA INTERNATIONAL QA CONFERENCE 2023

2022 delegate job roles

A word from carl The RQA Conference is always the highlight of our yearly schedule, and this year is no different. I am excited to take the conference to Belfast – a city rich in history, with a fantastic venue that has given us the opportunity to plan a wide-ranging programme, including a new stream specifically for anyone new to QA, which is a big step forward in catering for the varying degrees of experience we have in our community.

Following feedback from last year, we have altered the programme to include social learning in the last session of the day – you can choose to attend workshops or be involved in quality conversations around a specific topic with other liked-minded individuals. You can even volunteer and host a topic yourself.

I hope to see as many of you as possible in Belfast to share in what will be a busy two and a half days of work and play.

Carl, Conference Manager

RQA INTERNATIONAL QA CONFERENCE 2023

belfast Conference venue The ICC, 2 Lanyon Pl, Belfast BT1 3WH - Conference Venue Only 8 minutes from George Best City Airport, the ICC Belfast is Northern Ireland’s only purpose-built international convention centre situated right in the heart of Belfast.

The RQA International QA Conference will be held in the Riverside Concourse of the ICC, looking out across the River Lagan, through expansive windows letting natural light flood the rooms.

The ICC is located in the heart of the city centre, so there are lots of bars, pubs, restuarants and more to explore within easy reach.

More information on the venue can be found here: iccbelfast.com

Belfast City At one end of town lies a stretch of lively quayside, imbued with the fizz of people and a collective funloving spirit. To the other, an ominous smudge of dark green mountains just visible above the rooftops.

Somewhere between the two rises the Belfast of today, shaped by a notably turbulent past that now fuels its artistic, resilient soul, as well as some thought-provoking visitor experiences.

The second-largest city on the island of Ireland is stacked with history: it bore witness to the birth of the world’s most infamous cruise liner, Titanic, and emerged battleworn from decades of conflict. From making its early fortunes in the linen trade to becoming the gateway to numerous filming locations used in the Game of Thrones franchise, Belfast has seen it all.

For today’s visitor, it’s a city of diverse and characterful neighbourhoods, where revellers emerge rosy-cheeked from vibey watering holes in the Cathedral Quarter, and culture buffs browse the many museums, galleries and gardens of the Queen’s Quarter. The Gaeltacht Quarter is where you’ll hear the Irish language spoken and traditional folk music played; while the Titanic Quarter marks the city’s maritime heritage. Whichever you explore, you’ll find this capital is a brilliant, under-sung city break.

What else can I do?

You’ll find endless things to do in Belfast, from world-class attractions, historic landmarks, museums, shopping and entertainment venues, to walking, coach, taxi and bike sightseeing tours.

And as the gateway to Northern Ireland, Belfast is perfectly positioned for sightseeing tours to Giant’s Causeway, Game of Thrones filming locations and road trips beyond Belfast.

Travel times Near, far, wherever you are - it’s easy to get to Belfast!

From Dublin - 2hrs 15mins by train London - 1hr 30mins by plane Paris - 1hr 50mins by plane

RQA INTERNATIONAL QA CONFERENCE 2023

social events meet the delegates drinks reception Network with fellow QA colleagues at the ‘Meet the Delegates’ drinks reception on the evening of Tuesday 31st October 2023 in the Exhibition Area. Get a free drink and mingle with conference attendees, speakers and exhibitors.

new to QA - exclusive event Exclusively for our ‘New to QA’ delegates - the group will meet on the evening of Tuesday 31st October to get to know each other, meet your champions and the RQA Chair.

Dinner dance The White Star Line’s RMS Titanic was built just 20 minutes from the ICC, at the Harland and Wolff shipyard. Linking to this, and our conference title - what better theme for our Dinner Dance was there than ‘Titanic’? Full delegates get a free ticket as part of their conference package and individual tickets can be purchased when booking the conference for guests and one/two-day delegates.

RQA INTERNATIONAL QA CONFERENCE 2023

programme

As part of our 2023 initiative on development routes, the conference programme has been labelled with our three categories: learn, develop, extend - please view the website for information on these and a more detailed programme.

Pre-conference Tuesday 31st October 16.00 17.30

Registration (closes at 5.15pm) Meet the Delegates Drinks Reception

Day 1 Wednesday 1st November 08.00 09.00 09.15

Registration Conference Welcome Keynote Speaker - Prof Sir Jonathan Van-Tam 10.30 Networking Break

11.00

Regulators Update and Questions 12.30 Lunch GCP

QUALITY MANAGEMENT

IT

GVP

ANIMAL AND VETERINARY PRODUCTS

13.30

Issue management Building the Plane and SB reporting as We Fly It in the digital world – focus on system issues and data integrity

Navigating open source software technologies in GxP regulated environments: key insights for QA representatives

Maintaining pharmacovigilance compliance in an increasing complex regulatory environment

Animal and Veterinary Products workshop

14.15

DCTs and the evolving regulatory acceptance

Going off script: breaking away from traditional CSV test scripts with alternative risk-based approaches from GAMP 5 2nd Edition and FDA Computer Software Assurance (CSA)

Regulatory intelligence oversight

Animal and Veterinary Products workshop

What does a learner-centric experience look like in a GxP world? Workshop

Animal and Veterinary Products workshop

What is digital innovation and how can quality organisations leverage emerging technologies to support fast changing landscape

15.00 Networking Break SOCIAL LEARNING SESSION

15.30

Topical Tables

No centre, no clue?

Workshopping decentralised trials (DCT)

ICH-GCP draft updates and potential impact workshop

17.00 Close of Day 1

RQA INTERNATIONAL QA CONFERENCE 2023

Day 2 thursday 2nd November 08.00

GCP

09.00

Why don’t they do what we ask them to do?! The human factor in quality improvement

Diversity and inclusion

GCP QA Clinic

GLP

IT

GVP

GLP QA Clinic, including IT QA Clinic MHRA update

GVP QA Clinic

10.30 Networking Break GCP

GLP

IT

FUTURE OF QUALITY/ GVP

11.00

Detecting and preventing fraud and misconduct in a virtual world

Risk based process auditing approach

Computerised system validation approach with a focus on cybersecurity rules and regulations - panel

Ensure anytime inspection readiness by implementing quality circle

11.45

Serious breaches - new PMDA and sponsor European requirements GLP inspection conducted in Japan under the pandemic

AI how to validate it for GxP purposes in real life

Japanese Pharmacovigilance audit activity - new tide of quality assurance

CONSULTANTS

IT

12.30 Lunch GCP

13.30

ICH E8 R1: the renovation of Good Clinical Practice - a framework to support clinical trial implementation

14.15

Exploring the globe or stuck in the mud: ensuring your QMS vehicle is best positioned to reach its quality destination

GLP

Communication skills of The consultant’s life Hyperbole of AI an auditor workshop - exploring the 90% below the surface panel session

Harnessing the power of open source and open standards through the use case of Aranei and SonadorAI

15.00 Break SOCIAL LEARNING SESSION

15.30

Topical Tables

How can we embed Data Analytics capabilities within Drug Development Quality?

Workshop

Training and performance where is the missing link?

Workshop

17.00 Close of Day 2

Sponsor Workshop

RQA INTERNATIONAL QA CONFERENCE 2023

programme

For a more detailed programme, please visit the RQA website.

Day 3 friday 3rd November GCP

09.00

Exploring FDA’s bioresearch monitoring (BIMO) programme

09.30 09.45 10.00

BREAKING THE ICE

MHRA/EMA/FDA - ICH E6 R3

Risk management from an audit Breaking the status-quo: an perspective effective approach for supplier management in clinical research Left out in the cold - deep dive on supply chain disruption and potential mitigation

TBC

How advanced quality event management optimises resources and saves Your bottom line

QRM and quality - making sure fear doesn’t undermine your QRM programme

10.30 Break 11.00

QUALITY MATTERS

Sponsor Keynote by Sparta Systems, a Honeywell Company 12.30 Close of Conference

RQA INTERNATIONAL QA CONFERENCE 2023

new to qa - programme *plenary sessions, joining the main conference programme.

pre-conference tuesday 31st october 16.00 17.30

Registration opens New to QA Drinks Reception and Welcome

Day 1 Wednesday 1st November 08.00 09.00 09.15

Registration opens (if not previously registered) Conference Welcome* Keynote Speaker - Prof Sir Jonathan Van-Tam* 10.30 Networking Break

11.00

Regulators Update and Questions* 12.30 Lunch

13.30

Welcome session - breaking the ice

14.15

Quality Systems - A View from the Crow’s Nest 15.00 Networking Break

15.30

Topical Tables - join the rest of the conference for this social learning session* 17.00 Close of Day 1

Day 2 thursday 2nd November 09.00

A curated session by your New to QA champions 10.30 Networking Break

11.00

Keeping your cool in QA workshop 12.30 Lunch

13.30

ALCOA (Attributable; Legible; Contemporaneous; Original; Accurate) workshop 15.00 Networking Break

15.30

Topical Tables - join the rest of the conference for this social learning session* 17.00 Close of Day 2

Day 3 friday 3rd November 09.00

A curated session by your New to QA champions 10.30 Networking Break

11.00

Sponsor Keynote by Sparta Systems, a Honeywell Company* 12.30 Close of Conference

RQA INTERNATIONAL QA CONFERENCE 2023

a word from rqa chair, tim The theme of the 2023 conference is ‘Breaking the ice: exploring the depths of quality’. The programme will feature a variety of speakers and sessions on topics related to Quality Assurance and Regulatory Compliance in across the GXPs. Topics will include: − − − −

The latest trends in research quality Best practices for quality assurance Regulatory compliance in research The future of research quality

The conference will also offer opportunities for networking and collaboration with other professionals in the field. There will be a dedicated exhibition area where attendees can meet with exhibitors and learn about the latest products and services for research quality.

Here are some of the benefits of attending the RQA Conference Belfast: − − − −

Stay up to date on the latest trends and best practices in research quality Learn from and network with other professionals in the field Gain insights into the future of research quality Get inspired to improve your own quality practices

If you are interested in research quality, I encourage you to consider attending the RQA Conference in Belfast. It is a great opportunity to learn, network, and be inspired.

I hope to see you there!

Tim Stiles RQA Chair.

Accommodation The Hilton is the closest hotel to the ICC and accommodation is available to book through our event partners, Successful Events here.

Please note, rates are first come, first served.

RQA INTERNATIONAL QA CONFERENCE 2023

pricing

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RQA INTERNATIONAL QA CONFERENCE 2023

Our sponsors We would like to thank our Platinum Sponsors, Sparta Systems, a Honeywell company for once again sponsoring this year’s conferences, as you are probably aware, as a not-for-profit company, rqa would not be able to run these events without the support of our sponsors and exhibitors. ‘’Sparta Systems, a Honeywell company, is excited to once again support RQA as the Platinum Sponsor for their pivotal annual event—the 2023 International QA Conference, and their International QA Virtual Conference. RQA’s Quality Assurance events are instrumental in advancing the knowledge and expertise of professionals in the scientific research community, which aligns with RQA’s mission. These events offer opportunities for training, communication, engagement, and collaboration, enabling professionals to stay informed on the latest trends and best practices in their field. We are pleased that Sparta Systems has been chosen to be the Platinum Sponsor for the 2023 event in Belfast. We very much look forward to demonstrating our dedication through inspiring discussions and supporting RQA’s vision to promote the growth and development of the scientific research and life sciences community.

We are excited to continue our partnership with RQA in 2023 and beyond.’’

Also, thanks to our gold and silver sponsors:

BOOK NOW at www.therqa.com

for any questions use our web chat or email conferences@therqa.com join the conversation online or in the community hub #RQA2023