April 24

Filtering by: April 24
Workshop—Your Blueprint for Inspection Readiness
Apr
24
9:00 AM09:00

Workshop—Your Blueprint for Inspection Readiness

Workshops are NOT included with Full Conference registration and require a separate fee.

Are you fully prepared for a U.S. Food and Drug Administration (FDA) inspection? Inspections can be high-stakes events that bring stress, potential delays, and reputational risk if not managed effectively. This comprehensive full-day workshop is designed to help quality, regulatory, and research professionals approach inspections with confidence, clarity, and a concrete plan.

Moving beyond generic advice, the session delivers a structured, actionable framework—your blueprint for achieving and sustaining inspection readiness. Participants will learn how to build a proactive inspection strategy, master pre-inspection preparation, assemble and train an effective readiness team, and navigate inspection day with assurance.

The workshop emphasizes practical, real-world tactics supported by examples and interactive discussions. Attendees will leave equipped with proven tools and a step-by-step approach to strengthen their organization’s inspection readiness, reduce risk, and maintain compliance—transforming a daunting process into a manageable, even strategic, opportunity for operational excellence.

CEUs: 4.50 ACRP

Trainer:

View Event →
Workshop—Mastering Patient Recruitment in Today’s Clinical Research Landscape
Apr
24
9:00 AM09:00

Workshop—Mastering Patient Recruitment in Today’s Clinical Research Landscape

Workshops are NOT included with Full Conference registration and require a separate fee.

Patient recruitment remains one of the toughest challenges in clinical research, despite years of innovation and investment. While sponsors and CROs often provide recruitment solutions, the real work of identifying, engaging, and supporting patients happens at the site and community level.

This interactive workshop takes a practical, real-world look at today’s recruitment landscape. Attendees will first gain an overview of sponsor and CRO expectations, the resources they provide, and how sites can align with them. The focus then shifts to actionable strategies sites can implement immediately—emphasizing the human touch required to build trust, particularly with diverse populations.

The session also highlights emerging methods that leverage technology and data, including artificial intelligence, to strengthen traditional approaches. Participants will leave with insights into the vendor landscape, practical tools for community-level engagement, and a clearer understanding of how to integrate both human-centered and data-driven strategies for better recruitment outcomes.

CEUs: 5.50 ACRP

Trainer:

View Event →
Workshop—Top 10 Lessons from ICH E6(R3) Implementation: Insights, Pitfalls, and Change Strategies
Apr
24
to Apr 25

Workshop—Top 10 Lessons from ICH E6(R3) Implementation: Insights, Pitfalls, and Change Strategies

Workshops are NOT included with Full Conference registration and require a separate fee.

Since ICH E6(R3) was finalized, the industry has recognized that implementation goes beyond updating SOPs. It requires new ways of working, proportionate risk-based approaches, and a culture that prioritizes quality and critical thinking. This interactive workshop builds on the momentum of ACRP’s “Crack the Code” webinar, diving into the realities of R3 implementation.

Through the “Top 10 Lessons,” we’ll examine challenges and successes—embedding Quality by Design in protocol development and site operations, overseeing service providers, making data governance actionable, and defining what qualifies as an “important” protocol deviation.

Lessons will be brought to life with concise teaching segments, case studies, and interactive activities. Participants will practice applying these lessons to realistic scenarios, discuss solutions with peers, and leave with tools ready for use.

At the core of the workshop is change management, engaging stakeholders, equipping teams with the right tools, and empowering people to embrace new ways of working.

CEUs: 4.50 ACRP

Trainer:

Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates

View Event →

Opening Night Celebration
Apr
24
5:00 PM17:00

Opening Night Celebration

Celebrate the opening of ACRP 2025! Stop by the Expo for some bites, drinks, fun – and the chance to make meaningful connections with your community.

Stop by the HCA Healthcare Headshot Studio for a complimentary professional headshot—perfect for enhancing your credibility and making a lasting impression.

View Event →
Workshop—Clinical Trial Budgeting Basics: Tips and Tricks for Success
Apr
24
1:00 PM13:00

Workshop—Clinical Trial Budgeting Basics: Tips and Tricks for Success

Workshops are NOT included with Full Conference registration and require a separate fee.

Do you feel on top of all the sources of costs at your site, or are you surprised over and over by unexpected instances of expense? This pre-conference workshop is a great opportunity to learn the basics of clinical trial budgeting and the tips and tricks to ensure your clinical research site is accounting for the true costs to run each clinical trial you conduct. This workshop is intended for those new to budgeting and those experienced who want to ensure they are prepared for handling both the obvious and hidden wellsprings of revenue and deserts of debt throughout their studies. 

Objectives:

  • Discuss the importance of the clinical trial budget for site sustainability and success.

  • Identify critical costs to incorporate into your clinical trial budget.

  • Review the importance for justification documents.

CEU: 4.00 ACRP

Trainer:

View Event →
Workshop—Jazzing Up Risk: Harmonizing Risk Management and a Culture of Quality
Apr
24
1:00 PM13:00

Workshop—Jazzing Up Risk: Harmonizing Risk Management and a Culture of Quality

Workshops are NOT included with Full Conference registration and require a separate fee.

In this interactive 4-hour workshop, participants will explore how an organization’s culture of quality can significantly impact the success of its risk management approaches and outcomes. You will learn how a high-performing culture of quality enhances risk management by supporting robust, proactive processes, while a lower-performing culture can hinder these efforts. Through hands-on activities, real-world case studies, and simulations, participants will gain insights into the practical effects of culture on risk management, from identifying critical risks to implementing mitigation and monitoring strategies. By the end, you’ll leave with a deep understanding of how the culture of quality shapes risk management in clinical trials.

Objectives:

  • Understand how a high-performing versus lower-performing culture of quality impacts risk management processes and outcomes.

  • Learn to assess Critical to Quality (CTQ) factors, critical processes, and data in clinical trials with consideration of the influence of quality culture.

  • Develop skills in conducting risk assessments, including identifying and evaluating risks, and planning mitigation strategies.

  • Explore continuous risk monitoring methods and how a culture of quality influences these approaches.

  • Apply a maturity model to assess your organization’s current culture of quality and understand its role in shaping risk management decisions.

CEU: 4.00 ACRP

Trainer:

View Event →
Workshop—Vital Signs: Evaluating the Health of Your Clinical Research Program
Apr
24
8:00 AM08:00

Workshop—Vital Signs: Evaluating the Health of Your Clinical Research Program

Workshops are NOT included with Full Conference registration and require a separate fee.

This session provides a framework to assess the overall "health" of your clinical research program in terms of its most critical areas. By delving into key areas in compliance, business, financial, regulatory, and clinical dimensions, the session will help attendees identify gaps and inefficiencies in their programs. Participants will complete a scorecard covering essential topics, leading to an overall health score and follow-up action plans.

Objectives:

  1. Explore critical, key aspects of compliance, business, financial, regulatory, and clinical dimensions that contribute to the “health” of a clinical research program

  2. Identify potential gaps, inefficiencies, and areas for improvement within your clinical research program.

  3. Identify best practices to improve performance, compliance and regulatory adherence.

  4. Commence formulating a plan to start addressing identified gaps and inefficiencies, to enhance the overall performance and integrity of your research program.

CEU: 4.00 ACRP

Trainers:

Related Blog Content:

View Event →
Workshop—Project Management Basics for Clinical Research
Apr
24
8:00 AM08:00

Workshop—Project Management Basics for Clinical Research

Workshops are NOT included with Full Conference registration and require a separate fee.

Are you ready to thrive in your position instead of merely trying to survive while putting out fires? If so, there’s no time like the present to add or update the modern project management skills you will need in your arsenal when facing challenging projects to come.

Whether you currently manage projects, would like to in the future, or just want to be more effective in your position, there are skills you can develop and refine to boost your success. 

This workshop is for clinical research professionals who want to develop their leadership, communication, and management skills to help them successfully manage projects and lead teams.

This workshop will focus on the following topics: 

  • Traits and competencies of a good Project Manager - Do you possess them? (Are you a MacGyver?) 

  • Communication Skills - Speak, write, listen, understand, deliver 

  • Conflict, Negotiation, and Influence - Finding common ground and being open to alternatives 

  • Time Management, Planning, and Scheduling - Do you RASCI? 

  • Project Budgets and Cost Management - Who needs to know the dollars and sense of the project? 

  • Collaboration and team building, even with a remote or hybrid team - Building relationship within and outside the team (and over the internet) 

  • Leadership and taking the lead - Do you have to be at the front of the line to be a leader? 

  • Work life balance - Finding the balance in YOUR life 

Tools, assessments, and other resources will be discussed and provided so attendees can build on the information shared during the workshop and continue to develop their project management and leadership skills after the workshop. 

CEU: 8.00 ACRP

Trainers:

Related Blog Content

View Event →