(W190) Good Clinical Practice Essentials: What You Won’t Learn from the Regulations
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, Director, Regulatory Affairs,
Quorum Review IRB

JoAnn Jessen, President, Principal Consultant,
Pharma Compliance Partners

Gina Nesbit, Research Manager,
Northeast Georgia Heart Center

(W191) Dissecting a Clinical Trial Agreement
Sometimes the wording does make a difference. We will examine 30 key points in MAGI’s model clinical trial agreement. If you think you know what you’re signing, think again; it’s ugly in there. Have you considered this scenario…

Robert Croog, JD, Corporate Counsel,
PTC Therapeutics

Melissa L. Markey, JD, Attorney,
Hall, Render, Killian, Heath & Lyman, PLLC

Jonathan Walland, Director, Clinical Cancer Research,
John Theurer Cancer Center

(W199) Are You Next on the Fed’s Fraud and Abuse Hit List?
Sponsors and sites must navigate a maze of complex and conflicting federal rules when negotiating budgets and billing government payers. After reviewing the anti-kickback statute and false claims act, we will discuss difficult compliance challenges facing sponsors and sites in the contract negotiation process. The “pre-award” discussion will include a step-by-step demonstration on how to perform a Medicare/Medicaid coverage analysis and techniques for ensuring pricing is at fair market value. Real-life examples of “post-award” implementation challenges from a site perspective will also be discussed.

Debbie McAllister JD, President,
Debbie K. McAllister & Associates LLC

Robert Romanchuk, Director,
Novant Clinical Research Institute

(W203) Productive Sponsor-Site-CRO Relationships
An effective three-way relationship between sponsors, sites and CROs requires realistic expectations, clear communications, shared understandings, practical policies, and efficient problem resolution. In this interactive workshop, we will address common obstacles, their underlying causes, and how to avoid or mitigate them. Bring your own real-life situations... and be prepared to see all sides of the story.

Kathy Ford, VP, Operations (former),
Millenium Pharmaceuticals

William B. Smith, MD, President,
New Orleans Center for Clinical Research

Alan Braverman, PharmD, VP, North American Operations,
PSI

(W179) Biostatistics for Mere Mortals
Statistical concepts you need to understand: significance, power, sampling, randomization, tests of hypothesis, and more!

Nicole Close, PhD, President and Principal Biostatistician,
EmpiriStat

Ryan Crews, Clinical Scientist & Operations Manager, CLEAR,
Rosalind Franklin University

(W204) Building & Sustaining High-Performance Teams
Project teams, matrix teams, cross-organizational teams. Learn how to create teams, how to build trust among members, the leader's role, and effective team problem solving and innovation.

Barry Sagotsky, Partner,
Asherman Associates

Tanya Klaslo, Director, Global Submissions Management,
MedImmune

Vibhuti Singh, MD, President,
Suncoast Cardiovascular Research

(W335) Good Clinical Practice: Ask the Experts
An informal discussion with GCP experts.

Cathy Dykes, Senior Nurse Research Coordinator,
National Naval Medical Center

Rucha Majmundar Mehta, Independent GCP Auditor,
Mehta Hospital & Cardiopulmonary Care Center

Sule Mene, CEO,
Mene Research

(W176) Protocol Development: Science in Practice
Developing protocols that generate useful data, are practical for sites to implement, are acceptable to subjects, and work internationally.

Marga Oortgiesen, Managing Director, VP Drug Development,
Cato Research

Atul Kumar, MD, Staff Physician, Gastroenterology & Hepatology,
Veterans Affairs

(W178) Words to the Wise: Government Enforcement Activity in Research
Lessons learned the hard way..

Eve Brunts, JD, Partner,
Ropes & Gray LLP

Toni Harbour, MPH, CCRC, Lead Clinical Research Coordinator,
Starlight Clinical Research

Jesse Witten, JD, Partner,
Drinker Biddle & Reath LLP

(W820) Challenges in Conducting Medical Device Trials
Practical aspects of conducting device trials.

Billy Guthrie, Manager, Clinical Operations,
Abbott Vascular

Jan Kosmyna, Project Manager,
Cleveland Clinic

Manu Sondhi, MD, Associate Medical Director, Safety Surveillance,
Boston Scientific

(W188) Public Speaking 2.0: Stage Presence
From business meetings to industry conferences, clinical research offers many opportunities for public speaking. This interactive workshop will focus on stage presence: authenticity, vocalization, animation and engagement.

Shannon McBride, Sr. Clinical Research Associate,
Omnicare Clinical Research

Suzanne Wright, Clinical Research Manager,
Comprehensive Weight Control Program

(W419) Clinical Trial Offices: A Discussion about Challenges and Best Practices
A moderated discussion about academic medical center and other clinical trial offices.

Tammy Anderson, Director, Clinical Trials Office,
Virginia Commonwealth University

(P101) Chairman's Opening Remarks
How to get the most out of the conference.

Norman M. Goldfarb, CRCP, Chairman,
MAGI

(P401) The Future of the Clinical Research Enterprise
Quantitative analysis reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges?

Kenneth A. Getz, Senior Research Fellow,
Tufts Center for the Study of Drug Development

10:30am - 12:15pm
(A104) Managing Risk: Informed Consent, Subject Injury, Indemnific-ation & Insurance
Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first.

Barbara Longmire, Director, Office of Clinical Trials,
University of North Carolina

Kathleen Sauvé, JD, Sr. Legal Counsel, Early Stage, PharmaNet

J. Michael Slocum, JD, President, Slocum & Boddie, P.C.

10:30am - 11:15am (B160) Budget Development & Analysis
How do sponsors develop study budgets? How do sites price their services?

Perrie P. Lopez, Manager, Clinical Budgets & Analysis,
Global Development Operations, Bristol-Myers Squibb

Valera Bussell, Clinical Research Director, The Billings Clinic Research Center

11:30am - 12:15pm (B161) Budget Negotiation
Now that we know what we need, how do we get it?

Kristen Heath, JD, Manager, Commercial Contracts, Americas, Chiltern

Mindy White, Director, Clinical Trials Office, Meharry Medical College

10:30am - 11:15am (C814) Recent FDA Warning Letters
What FDA says about the problems they find.

David Vulcano, Assistant Vice President,
Clinical Research,
HCA, Inc.

11:30am - 12:15pm (C132) Working with IRBs - The IRB's Perspective
You can do it the hard way or the easy way.

Melissa Abraham, PhD, Chairperson, Human Research Committee, Partners HealthCare

Marjorie Speers, PhD, President and CEO, AAHRPP

10:30am-11:15am
(D214) Planning & Executing Global Trials
Effective methods and metrics.

W. Christopher Fang, MD, Worldwide Director, Johnson & Johnson, DePuy

St. Clare Chung, VP, Operations, SciAn Services

11:30am-12:15pm
(D824) Project Planning & Metrics
Methods and metrics for managing clinical trials.

Laurie Halloran, President & CEO, Halloran Consulting Group

10:30am - 11:15pm
(E315) Subject Recruiting by Sites
Planning & implementing effective recruiting programs.

Robert Loll, VP, NBD and Strategy, (Pi) Patient interaction

Cosimo Spera,
Head Research, DecisionView

11:30am - 12:15pm
(E352) Electronic Media in Subject Recruitment
Six ways to recruit subjects through the Internet.

Mark Metzner, Marketing Manager, Community Research

Christopher Novak, Director, Alexian Brothers Center for Psychiatric Research

10:30am - 12:15pm
(F305) The Three Rs: Reading, 'Riting & 'Rithmeticing CTAs & Budgets
Learn the basics of clinical trial agreements and budgets. What are the key negotiating points? What are the common pitfalls?

James Armbrust, JD, Management,
Clinical Trial Business Operations, MedImmune

Don McCall, Research Manager, Piedmont Hematology Oncology

1:30pm - 2:15pm (A339) Intellectual Property Provisions
Sites are creating biosample repositories and developing bio-markers and other IP.

Sheila Mikhail, JD, Chief Legal Officer, NanoCor Therapeutics, Inc.

Melissa Markey, JD, Attorney, Hall Render

2:30pm - 3:15pm (A338) Publication Rights
Medical product companies are built on proprietary info. Publication is a primary mission of academic sites. Is there a middle ground?

Jeffrey Qureshi, JD, Senior Legal Counsel, Sandoz International GmbH

Karen Mullin, JD LLM, Senior Research Attorney, Boston University

1:30pm - 2:15pm (B823) Pricing Patterns & Trends
Where are site fees high? Where are they low? How are they changing?

Lori Shields, VP of Operations, Trial Planning Solutions,
Medidata Solutions Worldwide

2:30pm - 3:15pm
(B208) Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare.

Katherine Hammerhofer,
Director, Research Operations (former), Cleveland Clinic

1:30pm - 2:15pm (C133) Conflicts of Interest
The evolving landscape; implementing a COI system.

Nicole Pennington, Sr. IT Manager, Research Affairs, Johns Hopkins University School of Medicine

Travis Jackson, JD, Attorney,
Jones Day

2:30pm - 3:15pm
(C145) Adverse Events vs. Unanticipated Problems
Improve safety by reporting less.

Jaclyn Ong, Senior Clinical Research Coordinator,
Institute of Mental Health

Jeffrey Cooper, MD, Director, Huron Consulting Group

1:30pm - 2:15pm (D207) Edit Checks, Data Queries, and Data Cleaning
Clean data in three steps.

Kit Howard, Principal,
Kestrel Consultants

2:30pm - 3:15pm
(D331) Site Monitoring with an Auditor's Eye
Seeing the forest for the trees.

Terri Kelly, Consultant GCP Compliance Auditor, Achieve Quality, Inc.

Kathy Valasek, Quality Assurance and Regulatory Compliance Consultant, cQA Solutions

1:30pm - 2:15pm
(E323) Social Media for Subject Recruitment
Fad or fact?

Lance Nickens, President, The Patient Recruiting Agency

2:30pm - 3:15pm
(E322) Financial Management of Research Sites
Improving the bottom line.

Kathy Jones Beals, Chief Operating Officer, NeuroTrials Research, Inc.

1:30pm - 2:15pm (F209) Recent Developments in Human Subjects Protection Regulation
And, where are we going?

Cynthia M. Gates, JD, Vice President, Regulatory, Western IRB

Michael C. Roach, JD, Partner, Meade & Roach, LLP

2:30pm - 3:15pm
(F410) Technology Showcase
Clinical Conductor (site CTMS); eStudyBinder (eRegulatory management system)

Mike Kamish, VP,
R&D Director,
Bio-Optronics

Vito Losito, CEO & President, EntraLogix Systems Group

3:45pm - 4:30pm (A202) Sensible Payment Terms
Ten payment terms you need to know.

Sally Teeters, Director, Legal and Business Operations Management, Calistoga Pharmaceuticals

Terry Stubbs, President & CEO, ActivMed Practices & Research

4:45pm - 5:30pm
(A260) Just Medical Devices:
A Moderated Discussion
Just for people conducting clinical research with medical devices: challenges and solutions.

Dawn Rice, Director of Clinical Affairs, US HIFU

Palaniswamy Vijay, Director of Clinical Research, Biomet Microfixation

3:45pm - 4:30pm
(B118) Billing Compliance in Practice
Coverage analysis benefits and logistical challenges.

Toni Harbour, Clinical Research Compliance Officer, University of Utah

Geoffrey Schick, Director, Clinical Trials Research, Aurora Health Care

4:45pm - 5:30pm
(B361) Just Oncology: A Moderated Discussion
Just for people conducting clinical research in oncology: challenges and solutions.

Lynda Owen, Clinical Trials Manager,
Duke University Health Systems

Teresa Stewart, Executive Director, New Mexico Cancer Care Alliance

3:45pm - 4:30pm
(C366) Battle of the Regulations: FDA vs. OHRP vs. ICH
What are the important differences?

Quincy J. Byrdsong, Executive Director of Research Administration, Virginia Commonwealth University

4:45pm - 5:30pm
(C362)Just CROs: A Moderated Discussion
Just for CROs: challenges and solutions.

Marga Oortgiesen, Managing Director, VP Drug Development,
Cato Research

Efraim Roe Kozorovitsky, Executive Director, Medical Devices,
Premier Research

3:45pm - 4:30pm (D332) Finding and Keeping High-Performing Sites
Building long-term relationships that meet both site and sponsor needs.

Lisa Luna, SVP, Corporate Dev & Implementation, ePharmaSolutions

4:45pm - 5:30pm
(D363) Just Sponsors: A Moderated Discussion
Just for study sponsors: challenges and solutions.

Amnon Eylath, Director, Global Quality, ARIAD Pharmaceuticals

Megan Lawson,
Study Manager, Biomet Orthopedics

3:45pm - 4:30pm
(E337) Marketing & Business Development for Sites
Getting the word out and the studies in.

Kevin Ketels, CEO, KMED Research

Terence L. Webb, PharmD, VP, Business Development, Novellus Research Sites

4:45pm - 5:30pm
(E364) Just Sites: A Moderated Discussion
Just for study sites: challenges and solutions.

Debra Jones, Manager, Health Research Center,
Park Nicollet Health System

Elizabeth Soltero, Admin. Dir., Soltero Cardiovascular Research Center, Baylor University Medical Center - Dallas

3:45pm - 4:30pm
(F356) Misconceptions about CROs
You've heard the complaints; now hear the reality.

Efraim Roe Kozorovitsky, Executive Director, Medical Devices,
Premier Research

Lisa Sanders, PhD, Senior Clinical Research Scientist, Cato Research

4:45pm - 5:30pm
(F365) Just International: A Moderated Discussion
Just for people conducting international clinical research: challenges and solutions.

Antal Hajos, Managing Director & CEO Europe, Ecron Acunova GmbH

8:30am - 9:15am
(A108) Don’t Forget the Other Contract Terms
There’s a reason we call it “boilerplate.” Twenty contract clauses you need to understand.

Joan Meissner, JD, Corporate Counsel, ARIAD Pharmaceuticals

Lucy Robins, JD, Director, Clinical Research Contracts, University of Maryland Baltimore

9:30am - 10:15am
(A217) Clinical Trial Agreements for Investigator-Initiated Trials
What agreements look like when the site comes asking.

Joanne Cornacchia, Assoc. Dir., Clinical Agreement & Grant Management, AstraZeneca Pharmaceuticals

Frank Ingiosi, JD, Research Administrator, Contracts,
Thomas Jefferson University

8:30am - 9:15am
(B112) Tracking & Collecting Payments
Do the work; collect the payment.

Rachel Garman, Research Manager, Oncology, Cancer Care Northwest

Elizabeth Nugent, Senior Manager, Clinical Trials, Kaiser Permanente

9:30am - 10:15am
(B116) Introductory NIH Grants & Budgets
Developing budgets for NIH grants that get funded.

Matthew Staman, Managing Director, Huron Consulting Group

8:30am - 9:15am (C372) Subject Recruitment Advertising
Can ads be both effective and ethical?

Matt Baker, President & CEO, Compass Independent Review Board

9:30am - 10:15am
(C138) FDA Inspections of Research Sites
What to expect, what to do, and what not to do. How to make FDA inspections as painless as possible.

Patricia Murphy, Bioresearch Monitoring Specialist, FDA

Michelle Noe, Senior Regulatory Operations Officer, FDA

8:30am - 9:15am
(D327) eMonitoring: On-site and Remote
Laptop tools for study visits; techniques for remote eMonitoring.

Deborah Mange, Clinical Research Associate, IMARC Research

Jackie Parker, Clinical Research Associate, Novella Clinical

9:30am - 10:15am
(D329) Employee vs. Contractor
The pros and cons of using – and being – a contractor vs. an employee.

Susan L. Coultas, Clinical Research Consultant, InfoQuest Clinical Network

Dennis Glaser, President,
Glaser Research Group

8:30am - 9:15am
(E422) Motivating & Evaluating Study Coordinators
Getting the most out of your people.

Jorge Salazar, MD, Medical Director, MIMA Century Research

Karriem Watson, MD, Director of Clinical Research Development, Neurosurgery, University of Illinois at Chicago

9:30am - 10:15am
(E835) Working
with Difficult Investigators
Resolving issues and misunderstandings.

Jesus Irazabal, Phase IV Clinical Research Manager, Latin America, Novartis

Michelle Osso, RTOG Program Coordinator, Cancer Care Northwest

8:30am - 9:15am
(F407) The FDA's Perspective on Sponsors & CROs
Regulatory Case Studies & Best Practices

Michael E. Marcarelli, PharmD, Director, Division of Bio-research Monitoring, Office of Compliance, CDRH, FDA

9:30am - 10:15am
(F102) Working Across Cultures
Effective collaboration requires good communications that consider the other party's national and organizational culture. Focus on China & Mexico.

Rucha Majmundar Mehta, Indepen-dent GCP Auditor,
Mehta Hospital & Cardiopulmonary Care Center

Marlene Llopiz, MD, Regional Director for Latin America,
Venn Life Sciences

Jenny Zhen Qin, Senior CRA, Abbott Vascular

10:45am - 11:30am (A212) CTAs in Canada
How do Canadian and U.S. clinical trial agreements and processes differ?

Iris Hnik, JD, Internal Legal Counsel, The University of British Columbia

Tiffany Yancey, JD, GRO Associate Manager, Study Start-Up, PAREXEL International

11:45am - 12:30pm (A330) CTAs Outside the United States
How do clinical trial agreements and processes look in Europe?

Daphne Gandy, Manager, Commercial Contracts, Europe & India, Chiltern

Stephanie Scherf, LLM, Legal Counsel, PharmaNet

10:45am - 11:30am
(B205) Inside the OIG’s Toolbox
Anti-kickback, false claims, beneficiary inducements, and more!

Erin Lewis, JD, Counsel,
Baker & Daniels

11:45am - 12:30pm
(B357) Private Insurance Reimbursement
Pre-authorization processes and state mandates.

Stephanie Vasconcellos, JD, Attorney,
Neal, Gerber & Eisenberg LLP

Debbie McAllister JD, President, Debbie K. McAllister & Associates LLC

10:45am - 11:30am
(C350) FDA Inspections: Handling the Consequences
Dealing with the aftermath of an FDA inspection.

Carol Bognar, Sr. Director, GCP Services, The Weinberg Group

11:45am - 12:30pm
(C224) Ask the FDA
FDA representatives will answer your questions.

Michael E. Marcarelli, PharmD, Director, Division of Bioresearch Monitoring, Office of Compliance, CDRH, FDA

Patricia Murphy, Bioresearch Monitoring Specialist, FDA

Michelle Noe,
Senior Regulatory Operations Officer, FDA

10:45am- 11:30am
(D219) Improving the Site Startup Process
Decreasing cycle times and increasing research site satisfaction.

Soo Bang, Director, Contracts & Outsourcing, Pfizer

Arthur Waldbaum, MD, Clinical Investigator, Downtown Women's Health Care

11:45am- 12:30pm
(D223) Site Visit Follow-Up
Notes-to-file, visit reports, and corrective action plans.

Brigid Flanagan, Senior Manager, Clinical Studies, Fresenius Medical Care North America

Stacey L. Basham, President,
Rialto Quality Group

10:45am - 11:30am
(E211) Records Rescue: Cleaning Up After a Problematic Study Coordinator
When a study coordinator leaves you holding the bag.

Cynthia Monahan, Sr. Quality Assurance/Improvement Specialist, Partners HealthCare

Anne Looney, Research Coordinator, Mid Ohio Heart Clinic

11:45am - 12:30pm
(E318) Protocol Feasibility Analysis for Sites
How to determine if a study is feasible for your site.

Deena Bernstein, Director of Clinical Research, Sheridan Clinical Research

Denise Dorman, Clinical Research Director, Coastal Orthopedics & Pain Management

10:45am - 11:30am
(F291) IRB Outsourcing: A Case Study
How it works in the real world.

Diana Lenhardt, Manager,
Clinical Trial Operations,
Columbia St. Mary's

James Saunders, Vice President,
New England IRB

11:45am - 12:30pm
(F225) Assessing the Performance of IRBs
Metrics and guidelines for selecting and evaluating IRBs.

Felix Khin-Maung-Gyi, PharmD, CEO, Chesapeake Research Review

Keith W. Barber, Manager, Investigator Research Leading, Pfizer

1:45pm - 2:30pm
(A215) Understanding Your Insurance Policy
What is and is not covered may surprise you.

Amy Sinclair, Senior Vice President, William Gallagher Associates

Peter Sullivan,
Vice President and Principal, Sullivan Insurance Group

2:45pm - 3:30pm
(A420) Clinical Trial CRADAs with the Department of Veterans Affairs
Finding common ground with industry.

Amy Centanni, Director, Tech-nology Transfer, Department of Veterans Affairs

Jeffrey Moore, Ph.D., Acting Deputy Director, Technology Transfer Program, Department of Veterans Affairs

1:45pm - 2:30pm
(B125) Advanced NIH Grants & Budgets
Developing budgets for NIH grants that get funded.

Matthew Staman, Managing Director, Huron Consulting Group

2:45pm - 3:30pm
(B402) NIH Grants: Compliance
Regulatory rules for NIH grants.

LaDale George, Partner,
Neal, Gerber & Eisenberg LLP

Heather H. Pierce, JD, Associate, Ropes & Gray LLP

1:45pm - 2:30pm (C326) Recent Developments in Subject Data Privacy & Security
HITECH Act changes to HIPAA. Genetic privacy and biobanking.

Robyn Shapiro, JD, Partner,
Drinker Biddle & Reath LLP

2:45pm - 3:30pm
(C171) Medical Device Regulations
ISO's draft adverse event reporting rules. How drug and device regulations differ.

Arundhati Datye, MD, Associate Medical Director, Safety, Boston Scientific

Lori Vivian, Clinical Research Program Manager, Cleveland Clinic Foundation

1:45pm - 2:30pm
(D418) Country Selection in Global Trials Demographics, infrastructure, logistics and more.

Susan Flint, Sr. VP, Drug Development, Talaris Advisors LLC

Antal Hajos, Managing Director & CEO Europe, Ecron Acunova GmbH

2:45pm - 3:30pm
(D210) Global Outsourcing
Challenges in working with overseas partners.

Gordon Wynant, Sr. Clinical Outsourcing Manager, Global Clinical Develop-ment, Otsuka Pharmaceutical

1:45pm - 2:30pm
(E346) Starting a Research Site from Scratch
Getting off on the right foot...and avoiding the potholes.

Kristen Johnson, President, Mountain View Clinical Research

Bobbi Tafara, Director/Owner, Suncoast Clinical Research

2:45pm - 3:30pm
(E808) Starting & Running a Clinical Trials Office
Delivering value in a complex environment; a simple clinical trial management system.

Tammy Anderson, Director, Clinical Trials Office, Virginia Commonwealth University

Jill Kay, Associate Director, Office of Clinical Research and Trials, UC Irvine, School of Medicine

1:45pm - 2:30pm (F221) Adaptive Study Operations
How to apply adaptive techniques to operations like site monitoring.

Anthony Cunningham, Manager, Clinical Affairs, Health Decisions

2:45pm - 3:30pm
(F841) Buying Media for Subject Advertising
How to maximize the impact from your media budget.

Kevin Ketels, CEO,
KMED Research

Terry Stubbs, President & CEO, ActivMed Practices & Research

(P124) Stump the Experts
Clinical trial experts will try to answer your most perplexing questions.

Informal Get-Together in the Top of the Hub Lounge
Relax with old friends...and new ones on the 52nd floor of the Prudential Tower. (cash bar)

(W184) The Research Site Toolbox
50 forms, charts & tips that make life easier.

Derita Bran, Manager, Clinical Trials Operations,
UT Medical Group, Inc.

Michelle Nash, Research Manager,
St. Michael's Hospital

Shae Owens, Regulatory Affairs Coordinator,
Kootenai Cancer Center

(W192) The Big Four Terms: Indemnification, Subject Injury, Intellectual Property & Publication Rights
Indemnification, Subject Injury, Intellectual Property, and Publication Rights are the most complex terms in a clinical trial agreement and the most likely to bog down negotiations.

Deirdre M. Hedrick, Contract Manager,
Genentech

Karen Lodigiani, JD, Director of Corporate Sponsored Clinical Research Contracting,
Partners HealthCare

Molly Huggins, JD, Attorney,
Smith Moore Leatherwood LLP

(W193) Budget Development & Negotiation for Investigative Sites
Effective budget negotiation requires preparation: knowing your costs and developing the infrastructure and methodology to consistently maximize revenues. Conduct effective negotiations. Track actual results through to the organization's P&L. Workshop is also illuminating for research sponsors.

Lisa Benson, Director, Grants and Sponsored Programs,
Connecticut Children's Medical Center

Kelly Nottingham, Research Administrator,
Cleveland Clinic

John P. Neal, Chief Executive Officer,
Premier Clinical Management Organization

(W198) Productive Site Visits
Both sponsors and sites benefit from high-quality, GCP-compliant research. Learn how expert site monitors conduct thorough, efficient and unobtrusive site qualification, initiation, monitoring and close-out visits. Learn how expert study coordinators prepare for and support these visits.

Katherine C. Johnson, On Site Monitoring Manager for Global Research Operations,
PAREXEL International

Susan Smith, Clinical Research Coordinator,
Signal Point Clinical Research Center

Jill Matzat, President,
Medical Research Management

(W416) Operationalizing Compliance at the Clinical Research Site
Ensure compliance with human subjects protection, billing, conflict-of-interest and privacy laws and regulations. This workshop will demonstrate how to set up compliance plans, policies, SOPs, training, day-to-day operations, software applications, and auditing. This workshop is applicable to research sites of all sizes, from private practice to academic medical center.

Ali Sonel, MD, Associate Chief of Staff for R&D,
VA Pittsburgh Healthcare System

Kelly M. Willenberg, President,
Synergism, LLC

(W194) You Want What? Practical Negotiation Techniques
Effective negotiation is part of any constructive relationship. Expert negotiators are more likely to get what they want AND form stronger partnerships. Workshop will include five hands-on exercises. Learn skills you can use in all aspects of your life.

Barry Sagotsky, Partner,
Asherman Associates

Matt Stephens, Senior Contract Analyst,
MacroGenics

Jennifer Nobbe, Project Manager,
PharmaSeek, LLC

(W415) Regulatory Litigation & Law
What happens when a regulator commences legal or administrative proceedings? How does it all play out? Real-life stories from the legal trenches.

Robert Wanerman, JD, Senior Counsel,
Epstein Becker & Green, P.C.

(W206) Site Questionnaire Drafting Session
Help create MAGI's new inventory of standardized site selection questionnaire questions. Bring your site questionnaire. This workshop is a working session. It runs from 8:00am - 10:00am.

Stefan Comhaire, VP Clinical Research,
SGS US Testing Company Inc.

Mindy White, Director, Clinical Trials Office,
Meharry Medical College