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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI |
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| | | Contracts | 08:00 am - 10:30 am | Into the Abyss: Subject Injury and Indemnification
A deep dive into the subject injury and indemnification sections of clinical trial agreements.| • Phil Boyce, JD - Senior Research Program Manager - University of Virginia School of Medicine (leader) | | • Peter Sullivan, BS CIC - Principal - Sullivan Insurance Group | | • Leanne Tran, MD JD - Health Lawyer and Principal - JD MD Solutions | | • Jonathan Walland, LLB MBA - Senior Corporate Counsel - Pfizer Inc. |
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| 11:00 am - 12:00 pm | Creating and Using a CTA Negotiation Playbook
Creating and using backup language.| • Jody Ingebritsen-Howe - Manager, Clinical Research Contracts and Compliance - PFS Clinical | | • Robert King, JD - Principal - Takepoint Legal Services, LLC |
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| 01:00 pm - 02:00 pm | Intellectual Property Provisions in CTAs
Inventions, ownership, technology transfer, and common areas of conflict| • Shahnam Sharareh, PharmD RAC - Partner - Fox Rothschild | | • Tiffany Yancey, JD - Manager, Contracts - United Therapeutics Corporation |
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| 02:30 pm - 03:30 pm | Those Devilish Details: Key Words & Phrases in Clinical Trial Agreements
A few words can change everything.| • Iruka Ndubuizu, LLB LLM CRCP - Executive Director - Eureka Consulting, LLC | | • Michael Powers, JD - General Counsel - The GOG Foundation |
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| 04:00 pm - 05:00 pm | CTAs for Investigator-Initiated Trials
What agreements look like when the site comes asking.| • Rikki-Quinn James-Renz, MBA SSGB CRCP - Director of Contracts & Supplier Services, Supply Chain - Temple University Hospital | | • Shobita John - Counsel, R& D Transactions - Bristol-Myers Squibb |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | |
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| | | Budgets & Billing | 08:00 am - 09:00 am | Constructive Tactics for Effective Budget Negotiation
Using constructive tactics in an actual group negotiation.| • Marshall Morris - Partner - DelRicht Research |
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| 09:30 am - 10:30 am | Fair Market Value in Clinical Research
There's a right way to use it...and a wrong way.| • Susan Adler, BA MPA - Director, Clinical Research Operations - Hackensack Meridian Health Network | | • Elizabeth Frey Miller, JD - Manager, Global Site Contracts - Celgene Corporation |
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| 11:00 am - 12:00 pm | Hidden Costs
What costs do sites and sponsors incur that are not in study budgets and not "the cost of doing business"?| • Jane Jacob, PhD CCRP - Vice President - Orthofix | | • Henry Whitlark, MBA - Business Manager - Fox Chase Cancer Center |
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| 01:00 pm - 02:00 pm | Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare.| • Marie Jackson, PhD MBA - Senior Director Research Institute - Le Bonheur Healthcare | | • Deborah Suarez, MS CCRP CRCP - Administrative Director - Baptist Health South Florida |
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| 02:30 pm - 03:30 pm | Medicare Coverage Analysis Out of the Ordinary
Finding the limits of what Medicare will cover.| • Stephanie Price, MA - Research Coverage Manager - Baylor Scott & White Health | | • Michael Schwendiman - Research Compliance and Training Specialist - Ironwood Cancer and Research |
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| 04:00 pm - 05:00 pm | Sponsor Payments to Sites: Tips & Tricks
How to obtain timely payments in a respectful manner.| • Nicolas Cindric - CEO - WCG PharmaSeek | | • Shaun Williams - Vice President, Investigator Management Solutions - Syneos Health |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI | | • Mary Klote, MD CIP - Director, ORPP&E - Veterans Health Administration |
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| | | Regulatory Compliance | 08:00 am - 09:00 am | How Will COVID-19 Change Regulations & Compliance?
What looks obsolete now?| • Quincy Byrdsong, EdD CIP CCRP - Associate Vice President for Research Administration - WellStar Research Institute | | • David Vulcano, LCSW MBA CIP RAC - Vice President, Clinical Research Compliance & Integrity - HCA, Inc. |
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| 09:30 am - 10:30 am | Recent Developments in Subject Data Privacy & Security
Ongoing changes in privacy and security laws and regulations.| • Sarah McHenry, JD - Counsel - CSL Behring (leader) | | • Norbert Clemens, MD PhD CPI FACRP - Senior Manager Science & Clinical Affairs - Kaneka Pharma Europe N.V. |
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| 11:00 am - 12:00 pm | Informed Consent Under the Revised Common Rule
How is "key information" being presented now, and how should it be presented?| • George Gasparis - President - The PEER Consulting Group | | • Hye Won Kim, MS RAC CIP - Manager, Quality Assurance - WCG - Copernicus Group |
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| 01:00 pm - 02:00 pm | Would You Approve This COVID-19 Study? Study Approvals at the Edge
IRB reviews of studies right in the gray area when the risk equation has changed.| • Lindsay Abraham, JD CIP - IRB Chair - Regulatory Lead - WCG | | • Hallie Kassan - Director, Human Research Protection Program - Northwell Health |
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| 02:30 pm - 05:00 pm | GCP & Inspection Readiness
Whatever your experience as a study coordinator or CRA, you will optimize your conference experience with a solid foundation of GCP knowledge. We will cover important GCP topics, with recent FDA guidances, and inspection and audit findings. Using real-life case studies packed with practical information, this workshop will provide the groundwork for many topics covered later in the meeting. Bring your own GCP questions and dilemmas. Study sponsors and IRBs often request annual GCP training… Here’s your chance!| • Linda Coleman, JD CIP CHC CHRC CCEP-I - Director, Human Research Protection Program - Yale University (leader) | | • Janet Holwell, CCRC CCRA TIACR FACRP - Clinical Research Consultant/Trainer - Independent Contractor | | • Patricia Mendoza, BS BSN RN CCRC CHRC CCRP - Manager, Regulatory Affairs, Compliance, & Clinical Trial Mgt. - Houston Methodist Research Institute |
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| 02:30 pm - 05:00 pm | Master Class: Regulatory Compliance
This advanced program is designed for clinical research professionals with responsibility for regulatory compliance. Topics include regulatory flexibility and compliance in a public health emergency, the Department of Justice's China investigation, making sure investigators fulfill their IND responsibilities for IITs,, and dealing with conflicts of interest.
| • John Baumann, PhD - Associate Vice President Research Compliance - Indiana University (leader) | | • Laura Odwazny, JD MA Bioethics - Senior Attorney - U.S. Department of Health and Human Services | | • Sujatha Sridhar, MBBS MCE - Executive Director - University of Texas Health Science Center- Houston | | • Torrey Young, JD MPH - Attorney - Mukasey Frenchman & Sklaroff |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI | | • Jennifer Sheller, BS MPH - AVP, Clinical Operations - Merck |
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| | | Clinical Operations, Project Management and Risk Management | 08:00 am - 09:00 am | How Well Will Our Response to COVID-19 Transform Clinical Operations Long-Term?
Will the changes we are making last?| • Kenneth Getz - Deputy Director and Professor - Tufts Center for the Study of Drug Development |
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| 09:30 am - 10:30 am | Setting & Managing Priorities in a Clinical Project Schedule
How to allocate resources to ensure project success.| • Jessica Lugo, MS PMP CCRC - Clinical Trial Manager - ICON PLC | | • Dawn Sauro - Chief Development Officer - Clinipace |
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| 11:00 am - 12:00 pm | Bringing Studies Back Online After COVID-19
It won't be like flipping a switch.| • Antoinette Frankum, BA UCLA Executive Business Management - VP/Executive Director, Clinical Research - CROMSOURCE, Inc. | | • Rosanne Petros, PMP - Associate Director, Global Clinical Trials Management - Merck |
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| 01:00 pm - 02:00 pm | How Will COVID-19 Change Clinical Project Risk Management?
The outlandish doesn't look so outlandish now.| • Shanley Curran, JD BSN RN CHC CHRC CCRP - BSC RM CQA | | • Judith Skroback, CIP CRCP - Director of Clinical Research - SynCardia Systems, LLC |
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| 02:30 pm - 03:30 pm | Risk Statements: The Foundation of Risk Management
Risk management begins with a clear assessment of the risks and a plan to address them.| • Pam Dellea-Giltner, BS MBA CCRA - President - PDG Clinical Consulting LLC | | • Glenda Guest, BS CCRA RQAP-GCP TIACR FACRP - President - Assured of Quality Consulting & Training |
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| 04:00 pm - 05:00 pm | Assessing & Characterizing Risk in Clinical Research
To understand a risk, you need to understand severity, probability, contingencies and whole lot more.| • Dawn Niccum, RN/MS CCRA RQAP-GCP PMP - Sr. Director, Quality Assurance and Compliance - inSeption Group | | • Kristin Stallcup, MSHS PMP - Senior Director, Customer Success - Covance |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI | | • Jeff Kingsley, DO CPI FACRP - CEO - IACT Health |
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| | | Site Management | 08:00 am - 09:00 am | How Will COVID-19 Change the Site Landscape? A Panel Discussion
All of sudden, it looks very different now...or does it?| • Wade Strzinek - Senior Director of Business Development - Elligo Health Research (moderator) | | • Dustin Caldwell - Director of Strategic Development - Optimed Research | | • Michael Casey - Executive Director - hyperCore International | | • Eve Sakran, MS CHRC - Director of Research Operations - Georgetown University Medical Center |
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| 09:30 am - 10:30 am | Run Your Site Like a Business During & After COVID-19
The priorities just changed.| • Ari Axelrod, MS PhD MBA CFA - Managing Director - Boston Clinical Trials | | • Jeanie Gatewood, MBA - Vice President - Fox Chase Cancer Center |
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| 11:00 am - 12:00 pm | How Will COVID-19 Change Marketing & Business Development? A Panel Discussion
Is it a new day?| • Steven Clemons, MSN FNP-BC NPC - Founder / Chief Executive Officer - VitaLink Research (moderator) | | • Michael Koren, MD FACC FAPCR CPI - CEO and Medical Director - Encore Research Group | | • Carlos Orantes, BS MBA - CEO - Meridien Research | | • Jeff Repper, BA - Vice President - MediSync Clinical Research |
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| 01:00 pm - 02:00 pm | Ramping Up a Site after COVID-19
Proceeding in an orderly fashion to achieve a new, better state.| • John Maloy, JD - Assistant Vice Chancellor for Research Management - LSU Health Sciences Center - Shreveport | | • William B. Smith, MD FACC - President - NOCCR/VRG, An AMR Company |
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| 02:30 pm - 05:00 pm | Master Class: Site Management Innovations & Best Practices for Institutional Sites
KPI dashboards, revenue/coordinator, diversity in the workforce, moving to a shared service model, recruiting from multiple independent sites, and following up when a patient goes to another provider.| • David Russell - Director, Site Strategy - PFS Clinical (leader) | | • Bishoy Anastasi, MPH MBA CCRP - Director, Clinical Research Finance - University of California, Los Angeles | | • Kathleen Bienkowski - Independent Contractor - Independent Contractor | | • Patricia Black, MBA BBA - Manager, OCR-Business Operations - Fox Chase Cancer Center | | • Todd Davies, PhD - Director of Research Development & Translation - Marshall Clinical Research Center |
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| 02:30 pm - 05:00 pm | Master Class: Site Management Innovations & Best Practices for Independent Sites
Strategic planning, detailed site brochures, going all digital, generating physician referrals, and preparing for post-COVID-19.| • Stephen Loosli, MSc - Executive Director - Boeson Research (leader) | | • Jill Heinz, MHS CCRC CRCP - President, Family Care and Injury Care Research - Injury Care Research | | • Gina Robles, BS - VP, Clinical Operations - Long Beach Clinical Trials | | • Devora Torrence, CCRC - President - Centex Studies, Inc. | | • Vivienne van de Walle, MD PhD BSci FAPCR CPI - Medical Director - PreCare Trial & Recruitment |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI |
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| | | Professional Skills | 08:00 am - 10:30 am | Building & Sustaining High-Performance Teams
Leaders, colleagues and sponsors: High performance teamwork drives higher-quality outcomes.| • Suzanne J. Rose, MS PhD CCRC - Director, Office of Research - Stamford Hospital (leader) | | • Kristy Averette, RN BSN BA CCRP - Research Practice Manager - Duke University School of Medicine | | • Kimberly Guedes, RN BSN - Vice President Clinical Operations and Project Management - Centrexion Therapeutics Corp | | • Gloria Morgan, BS MS PMP - Director of Clinical Operations - SRI International |
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| 08:00 am - 10:30 am | From Manager to Leader
It's a different mindset.| • Barry Sagotsky, MBA - Owner - Magnolia Lane Consulting (leader) | | • Mary Anne Hinkson, MBA - Vice President, Research Operations - MedStar Health Research Institute | | • Stacey Stein, Masters Degree-Organizational Leadership and Psych - Director, Clinical Development - Clinipace |
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| 11:00 am - 12:00 pm | Working with Remote Teams
Maintaining quality, efficiency and cohesion with remote teams.| • Amy Raymond, PhD PMP - Director of Therapeutic Expertise - PRA Health Sciences | | • Julie Wainscott - Associate Director, SSU & Regulatory - Syneos Health |
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| 01:00 pm - 02:00 pm | Managing in a Complex Organization
Dealing with multiple authorities, departments and stakeholders.| • Ronald Waife, MPH - President - Waife & Associates, Inc | | • Barbara Weber, MBA, BS - Principal - Petasus, LLC |
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| 02:30 pm - 03:30 pm | Minimizing and Managing Staff Burnout & Turnover
Keeping your people motivated and engaged.| • Reginald Hooks, MS MPH PMP - Associate Director - Oncolytics Biotech | | • Jeffrey Smyth, MS CCRP - VP/Chief Operating Officer - MOORE Clinical Research, Inc. |
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| 04:00 pm - 05:00 pm | Conflict Resolution
Practical methods to resolve conflicts and generate a positive outcome. (Conflict resolution modes (CRM) assessment available at extra charge.)| • Casi Morales, JD - Contract Manager - University of Utah | | • Barry Sagotsky, MBA - Owner - Magnolia Lane Consulting |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI | | • David Vulcano, LCSW MBA CIP RAC - Vice President, Clinical Research Compliance & Integrity - HCA, Inc. |
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| | | Special Topics | 08:00 am - 09:00 am | How Will COVID-19 Change Site Selection? A Panel Discussion
Who can you trust when the going gets tough?| • Cynthia Dukes, PA MT - VP, Drug Development Services - ICON PLC (moderator) | | • Greg Adams - Director, Investigator Site Development - Pfizer Inc. | | • Shawne Moran - Sr. Director, Strategic Development - IQVIA | | • Chrystal Olney - M Site Development Lead - AstraZeneca Pharmaceuticals |
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| | | Site Management | 09:30 am - 10:30 am | Accelerating Study Startup at the Site
Best practices for quick site startups.| • Terry Stubbs, MA CCRC AS CRQM - President CEO - ActiveMed Practices & Research, Inc. | | • Scott Whitt, MA - President and General Manager - Triad Clinical Trials, LLC |
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| | | Special Topics | 11:00 am - 12:00 pm | Are You Hearing Us? Are We Hearing You? A Panel Discussion
What sponsors and CROs need to understand about sites...and what sites need to understand about sponsors and CROs, especially now.| • Jeffrey Rosen, MD - Chief Medical Officer - Alliance for Multispecialty Research, LLC (moderator) | | • Dayna Geralts, CCRP - Project Manager - Advanced Clinical | | • Mark Lacy - CEO Benchmark Research & CEO hyperCORE International - Benchmark Research | | • Nancy Sacco, PhD - Vice President - AnaptysBio |
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| 01:00 pm - 02:00 pm | How COVID-19 Has Taught Us to Streamline & Simplify Clinical Trial Processes
It's been quite a learning experience.| • Alyson Roeding, MBA CCRP CLSSBB CRCP - Clinical Research - Meridian Bioscience | | • Kent Thoelke, BS - Chief Scientific Officer - PRA Health Sciences |
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| | | Professional Skills | 02:30 pm - 03:30 pm | Overcoming Resistance to Change
How to get the sand out of the gears.| • Laura Halloran, BSN MS - President & CEO - Halloran Consulting Group | | • Christine Senn, PhD - Chief Implementation & Operations Officer - IACT Health |
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| | | Special Topics | 04:00 pm - 05:00 pm | How Will COVID-19 Change International Clinical Research? A Panel Discussion
Are different countries changing in different ways?| • Kimberly A. Dorsch, BS CCRP - Director, Global Clinical Affairs - LifeNet Health (moderator) | | • Barbara Bierer, MD - Faculty Director - Brigham and Women's Hospital | | • Ambra Cerri, PhD MBA Law degree - Chief Operating Officer - Scientific Research - IRCCS Policlinico San Donato | | • Ahmed Hamouda, MBA CCRP - Head of Clinical Operations - RAY-CRO | | • Richa Vellanki - Senior Project Manager - Zydus Cadila |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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| Plenary | 07:40 am - 07:55 am | Chairman's Opening Remarks | • Norman Goldfarb - Chairman - MAGI |
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| | | Special Topics | 08:00 am - 09:00 am | Take a Walk in our Shoes: The Patient/Caregiver Perspective: A Panel Discussion
Practical advice from study participants.| • Lori Abrams, BS, MSOD - Sr. Director, Patient Advocacy - WCG (moderator) | | • Kimberly Richardson - Research Advocate - University of Illinois Cancer Center | | • Dorelia Rivera - Parent - Autoinflammatory Alliance | | • Lilly Stairs - Founder & Principal - Patient Authentic |
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| | | Contracts | 09:30 am - 12:00 pm | Dissecting a Clinical Trial Agreement
Sometimes the wording does make a difference. We will examine 30 key points in MAGI’s standard clinical trial agreement template. If you think you know what you’re signing, think again; it’s ugly in there. Have you considered this scenario…| • Freddy Iwan - Head, Legal Management & Legal Counsel - WCG (leader) | | • Alexandra Colin, JD - Associate General Counsel - Baxter Healthcare Corporation | | • Chad League, JD - Senior Contracts and Grants Administrator - MedStar Health Research Institute |
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| | | Special Topics | 09:30 am - 10:30 am | How Will COVID-19 Change Patient Recruitment? A Panel Discussion
How have their preferences and priorities changed?| • Steve Smith - President, Patient Advocacy - WCG (moderator) | | • Jennifer Byrne - President - Greater Gift | | • Christopher Gantz, MBA BA - Senior Director - Sidney Kimmel Cancer Center | | • Faye O'Brien, PMP - Founder and President - Nvolve Inc. |
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| 11:00 am - 12:00 pm | Behind the Scenes: Developing a New COVID-19 Test and a New Vaccine
There are a lot of steps and a lot of decisions to be made.| • Ahsan Awan, BS JD MBA MSPharm - Vice President - Genlantis Diagnostics | | • Cynthia Dukes, PA MT - VP, Drug Development Services - ICON PLC |
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| | | Contracts | 01:00 pm - 02:00 pm | How COVID-19 Is Changing Clinical Trial Agreements
Fresh light on an old document.| • Conor Flynn, BS JD - Contracts Manager - State University of New York at Buffalo | | • Katherine Leibowitz, JD - Co-Founder - Leibowitz LLC |
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| | | Special Topics | 01:00 pm - 02:00 pm | How Will COVID-19 Virtualize Clinical Studies? A Panel Discussion
Previously, it was mostly talk.| • Jill Johnston - President, Clinical Services Organization - WCG (moderator) | | • Helen Kellar-Wood - Lead Patient and Site Engagement - Bristol-Myers Squibb | | • Craig Lipset - Advisor and Founder - Clinical Innovation Partners | | • Karri Venn, RD CDE CCRC - President, Research - LMC-Manna Research |
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| | | Budgets & Billing | 02:30 pm - 05:00 pm | Fundamentals of Coverage Analysis
Achieve a solid level of proficiency.| • Kelly Willenberg, DBA RN CHRC CHC CCRP - Manager - Kelly Willenberg & Associates (leader) | | • Amanda Miller, BS MS - Training Program Manager - PFS Clinical | | • Theresa Stone - Research Compliance Manager - Brigham and Women's Hospital |
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| | | Special Topics | 02:30 pm - 05:00 pm | Implementing a Quality Management System for Sponsors, Sites and CROs
In this interactive workshop, we will explore the interwoven processes and tools used in a Quality Management System.| • Suzanne Heske, RPh MS BCNP CCRA - Sr. Director, Quality Risk Management - Syneos Health (leader) | | • Tracy Morrison, MSN Healthcare Administration CCEP CHRC - Director of Quality for Clinical Research - PolarityTE | | • Kunthea Taing, MBA CQA RAC - Principal, Consultant, QAC2, Inc. - QAC2, Inc. |
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| | | Plenary | 05:00 pm - 05:15 pm | Chairman's Closing Remarks | • Norman Goldfarb - Chairman - MAGI |
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