Name: 2nd Clinical Quality Oversight
Start: 02/05/2023 10:00 AM +00:00
End: 03/05/2023 11:00 PM +00:00

With trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Our worldwide consulting services help ensure compliance while optimizing research performance, specializing in clinical, quality, regulatory, and institutional research.
https://www.advarra.com/consulting-services&nbsp;
&nbsp;

Advarra

inSeption Group is a leading global outsourcing company renowned for its exceptional service and commitment to quality. In today&rsquo;s rapidly changing industry, those values mean more than ever before.
At the core of inSeption Group&rsquo;s success is its ability to identify, engage, and retain experienced individuals dedicated to establishing quality structures and streamlined approaches for managing critical trial documents. Teams hold themselves to a high degree of excellence, efficiency, and strategic stewardship, and this unique culture means your records are complete, accessible, and inspection-ready at all times.

inSeption Group

ZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage our leading-edge analytics, plus the power of data, science and products, to help our clients make more intelligent decisions, deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 12,000 employees in 35 offices worldwide. To learn more, visit https://www.zs.com/or follow us on Twitter and LinkedIn.

Beaufort's mission is to help clients advance human health through the rapid development and commercialization of innovative products. Our shared interest and commitment to your success drives our entire organization to deliver best-in-class Clinical Monitoring Oversight solutions.&nbsp;
Beaufort is a pioneer in Clinical Monitoring Oversight, having established a robust and structured practice in 2010 and successfully providing full-service oversight on 40 projects for industry-leading life sciences companies. Our clients benefit from the expertise of a global team comprised of experts who understand the broad landscape and specific nuances involved in planning, managing, implementing, and maintaining a successful global Clinical Monitoring Oversight program. &nbsp;
Our proven processes and track record of success provides sponsors with:&nbsp;
Rigorous patient safety and protection&nbsp; On-site CRO CRA and site assessments &nbsp; Increased CRA performance and site efficiency&nbsp; Enhanced data integrity and security&nbsp; Pre-emptive key risk identification&nbsp; Improved timeline and budget monitoring&nbsp; Reporting to demonstrate to regulatory bodies that your trial meets the highest scientific, ethical, and regulatory standards&nbsp; &nbsp;
Given the wave of innovation across the industry and increase in regulatory scrutiny on CRO activities, &nbsp;the need for integrating Clinical Monitoring Oversight as part of the planning process is even more critical. &nbsp;&nbsp;
Contact us to learn more about how Beaufort can help safeguard the success of your clinical trial.&nbsp;

Beaufort

Let Momentum Virtualize Your Retreat, Recruitment, Training or Client Event - As most industries continue to adjust to life with limited to no live meetings or events, the need to create a valuable and impactful experience has never been greater. Whether it is a firm retreat, recruitment effort or client event, Momentum can virtualize your program and deliver a seamlessly executed program that removes any delivery risks and enhances the digital experience, all for the fraction of the cost of a traditional venue and without any subscriptions or long-term commitments.&nbsp;
vCaaS&trade;, virtual Conference as a Service, leverages our best in class technology platform, an assortment of virtual event provider relationships, and the meticulous nature of our event planning mindset to create a customized virtual event and social interaction platform that can seamlessly deliver content to an audience of your choosing. Our services can be used for:
<ul>
<li>Law firm and company retreats</li>
<li>Client events</li>
<li>Training courses</li>
<li>Recruitment activities</li>
<li>Expert roundtables</li>
<li>Bespoke conferences</li>
</ul>
As a full-service events company, we will also consult on session design and timing for the virtual environment, leveraging best practices, and provide complete end to end project management, acting as an extension of your team and &ldquo;general contractor&rdquo; for your retreat.
We can incorporate any or all of the following elements into your event:
<ul>
<li>Keynote addresses</li>
<li>Professionally produced video content (pre-recorded or live)</li>
<li>Multiple roundtables &amp; breakouts</li>
<li>Private meeting rooms</li>
<li>Virtual cocktail receptions</li>
<li>Embedded video chat</li>
<li>1:1 Matchmaking</li>
<li>Content delivery</li>
<li>Brand activation</li>
<li>Exhibition activation</li>
<li>Social events</li>
<li>and much more&hellip;</li>
</ul>
By working with Momentum, you can sit back and rest assured that your next event will be in safe hands with an events company that has 100+ combined years of executive leadership experience and 10+ years of working with dozens of virtual event platforms.
Don&rsquo;t waste your time evaluating the hundreds of virtual event platforms currently on market or stress of how to execute your digital event at the high standard your company expects, let Momentum take all the hassle off your plate and allow you and your team to focus on your core responsibilities.&nbsp;

Conference as a Service v(CaaS™) by Momentum

Ensure Trial Integrity, Patient Safety and Regulatory Conformity Right from the Start
<ul>
<li>Define the new landscape of clinical monitoring oversight</li>
<li>Recognize the importance of proactive oversight and risk-mitigation in your trial planning process</li>
<li>Understand what blind spots sponsors risk when not conducting proper on-site monitoring</li>
<li>Outline FDA reporting &ldquo;musts&rdquo; and the benefits of integrated clinical monitoring oversight &nbsp;</li>
</ul>
John R. Wilson, Jr., Ph.D., MPH Senior Vice President, BEAUFORT

John Wilson

THE RISING VALUE OF CLINICAL MONITORING OVERSIGHT

How Do We Ensure Our Quality Professionals Can Identify Quality Issues That Matter
<ul>
<li>What skills/qualifications do you look for in a quality professional?&nbsp;</li>
<li>What skills/attributes are no longer relevant?&nbsp;</li>
<li>How would you guide a rising quality professional to gain the skills necessary? &nbsp;</li>
</ul>
David Fryrear Executive Vice President, Head of Quality Assurance, ASTELLAS
Leslie Sam President, LESLIE SAM AND ASSOCIATES, LLC

David Fryrear

Leslie Sam

INTERACTIVE SESSION: QA COMPETENCY

Fine Tune your Inspection Readiness Plan with Insight from Recent GCP Inspection Experiences and Communication with Varying Regulatory Authorities
<ul>
<li>Learn the latest inspection gossip and what this might mean for your inspection readiness practices</li>
<li>Discuss the impact of Brexit on EMA and MHRA inspections</li>
<li>Understand how inspections have changed as ICH E6 has evolved &nbsp; &nbsp;</li>
</ul>
Stacey Basham Director, RDQA Supplier Lifecycle Qaulity, ABBVIE
Anthea Dransfield Managing Director, Quality Center of Excellence, ADVARRA
Dawn Lundin Head of Global Quality, MAPS PBC
Michael Wieczerzak, MS, MBA, MPH, CCRP Associate Director, Clinical Quality Management Lead, EMD SERONO
&nbsp;
CHAIRPERSON'S CLOSING REMARKS
David Fryrear Executive Vice President, Head of Quality Assurance, ASTELLAS

Agenda

Speakers16 Speakers

David Fryrear

Paul Houri

Jonathan Rowe

John Wilson

Jacalyn Vander Ploeg

Stacey Basham

Anthea Dransfield

Dawn Lundin

Michael Wieczwezak

Leah Andrews

Jacob Braude

Anne Marie Inglis

Leslie Sam

Tim Stoddard

Michele Weitz

Prajna Kumar

Booth5 Booth

Advarra

inSeption Group

ZS

Beaufort

Conference as a Service v(CaaS™) by Momentum

Agenda

Speakers.css-2zwi6c{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#494949;font-family:'Poppins',sans-serif;margin-left:0.8rem;}16 Speakers

David Fryrear

Paul Houri

Jonathan Rowe

John Wilson

Jacalyn Vander Ploeg

Stacey Basham

Anthea Dransfield

Dawn Lundin

Michael Wieczwezak

Leah Andrews

Jacob Braude

Anne Marie Inglis

Leslie Sam

Tim Stoddard

Michele Weitz

Prajna Kumar

Booth.css-1c6umu4{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#494949;font-family:'Poppins',sans-serif;color:#ffffff;margin-left:0.8rem;font-weight:400;}5 Booth

Advarra

inSeption Group

ZS

Beaufort

Conference as a Service v(CaaS™) by Momentum

Speakers16 Speakers

Booth5 Booth