MAGI’s Clinical Research Conference - 2009E

Conference Program/Agenda


Sunday, May 31

12:00pm - 05:00pmEarly Registration
01:00pm - 05:00pmWorkshops:
(W179) Biostatistics for Mere Mortals
Statistical concepts you need to understand: significance, power, sampling, randomization, tests of hypothesis, and more!
(W187) Investigator-Initiated Research: The INDependent World of Sponsor-Investigators
Investigator-initiated clinical trials are rewarding, but they place new regulatory responsibilities on the principal investigator as the IND/IDE sponsor and on the clinical trials office. Case examples will demonstrate how to submit an investigational new drug application (IND) to the FDA. We will discuss the role of pharmaceutical and device companies as research partners. The workshop will include real-life experiences, practical tips, and interactive activities.
(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!
(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…
(W199) Avoiding Fraud and Abuse Pitfalls in Clinical Research Payments and Reimbursement
Sponsors and sites must work within legal and regulatory constraints when negotiating budgets and billing Medicare. Hands-on exercises will include performing Medicare/Medicaid coverage analyses and dealing with per-visit payments. We will also review contract language for anti-kickback, false claims, and state law implications.
(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.

05:00pm - 06:00pmEarly Registration
05:15pm - 06:45pmWorkshops:
(W176) Protocol Development: Science in Practice
Developing protocols that generate useful data, are practical for sites to implement, and are acceptable to subjects.
(W178) Words to the Wise: Recent OIG Settlements
What we can learn from their mistakes.
(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.

05:15pm - 06:45pm(X183) Find a Site - Find a Sponsor
If you are sponsor or CRO looking for good sites, or a site looking for good sponsors and CROs, this is your chance to meet some of the best. (This activity is NOT a presentation.)
07:00pm - 08:00pmInformal Get-Together at Brisa Bistro
Relax with old friends...and new ones. (cash bar)

Monday, June 1

07:30am - 08:30pmRegistration, Networking & Light Breakfast
08:30am - 09:00am(P101) Chairman's Opening Remarks
09:00am - 10:00am(P332) Finding and Keeping High-Performing Sites
Building long-term relationships that meet both site and sponsor needs
10:00am - 10:30amNetworking Break
10:30am - 12:00pmTracks:

Contracts10:30am - 12:00pm(A104) Managing Risk: Informed Consent, Subject Injury, Indemnification & Insurance
Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first.

Budgets & Billing10:30am - 11:10am(B160) Budget Development & Analysis
How do sponsors develop study budgets? How do sites price their services?
11:15am - 12:00pm(B161) Budget Negotiation
Now that we know what we need, how do we get it?

Regulatory & Ethics10:30am - 11:10am(C177) The Informed Consent Discussion
Building a framework and confirming understanding.
11:15am - 12:00pm(C344) Vulnerable Subjects
What the regulations don't say.

Sponsor Operations10:30am - 11:10am(D301) Recruiting & Motivating Investigators
How to find and motivate the best investigators for your study.
11:15am - 12:00pm(D349) Building and Implementing an Accurate Patient Enrollment Model for Your Study
Understanding and managing the assumptions.

Site Operations10:30am - 11:10am(E312) Quality Management for Sites
Delivering quality research before site monitoring.
11:15am - 12:00pm(E343) Making Sense of Self-Funded Clinical Research
Active management to support the institutional mission and generate funding.

Special Topics10:30am - 12:00pm(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?

12:00pm - 01:15pmLunch with Speakers
Join a speaker for lunch.
01:15pm - 02:45pmTracks:

Contracts01:15pm - 01:55pm(A202) Sensible Payment Terms
12 payment terms you need to know.
02:00pm - 02:45pm(A338) Publication Rights
Medical product companies are built on proprietary information. Publication is a primary mission of academic sites. Is there a middle ground?

Budgets & Billing01:15pm - 01:55pm(B417) Registry Study Budgets & Contracts
The business of safety.
02:00pm - 02:45pm(B208) Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare.

Regulatory & Ethics01:15pm - 01:55pm(C132) Working with IRBs - The IRB's Perspective
You can do it the hard way or the easy way.
02:00pm - 02:45pm(C141) Investigator-Initiated Trials
When investigators become sponsors, they accept additional responsibilities.

Sponsor Operations01:15pm - 01:55pm(D302) Investigator & Subject Recruiting in Latin America
How does investigator and subject recruiting in Latin American countries differ?
02:00pm - 02:45pm(D303) CDASH: Making Life Simpler with Standard Case Report Forms
The new CRF standards and their impact on clinical research.

Site Operations01:15pm - 01:55pm(E244) Clinical Trial Management Systems
How to streamline your operations with CTMS.
02:00pm - 02:45pm(E315) Subject Recruiting by Sites
Planning & implementing effective recruiting programs.

Special Topics01:15pm - 01:55pm(F423) Incidental Findings: Clinical, Regulatory & Ethical Obligations
Handling unexpected discoveries of medical problems.
02:00pm - 02:45pm(F102) Working Across Cultures
Effective collaboration requires good communications that consider the other party's national and organizational culture.

02:45pm - 03:15pmNetworking Break
03:15pm - 05:30pmTracks:

Contracts03:15pm - 03:55pm(A339) Intellectual Property Provisions
What happens when the research site invents something?
04:00pm - 04:40pm(A219) Improving the Site Startup Process
Decreasing cycle times and increasing research site satisfaction.
04:45pm - 05:30pm(A260) Just Medical Devices
A moderated discussion just for people conducting clinical research with medical devices: challenges and solutions.

Budgets & Billing03:15pm - 03:55pm(B213) The Sponsor’s Role in Medicare Reimbursement for Device Trials
What the sponsor must do; what the sponsor should do.
04:00pm - 04:40pm(B351) Labor Analysis
Labor is the main cost in clinical research -- how do you predict how much it will take?
04:45pm - 05:30pm(B361) Just Oncology
A moderated discussion just for people conducting clinical research in oncology: challenges and solutions.

Regulatory & Ethics03:15pm - 03:55pm(C182) Stem Cell Clinical Research Oversight
Impact of the Proposed NIH Guidelines on IRB/IECs and SCRO/ESCROs
04:00pm - 04:40pm(C324) Ethics Committees & Regulation in Latin America
How ethics committees and regulations vary across Latin America.
04:45pm - 05:30pm(C362) Just CROs
A moderated discussion just for CROs: challenges and solutions.

Sponsor Operations03:15pm - 03:55pm(D214) Planning & Executing Global Trials
Effective methods and metrics.
04:00pm - 04:40pm(D404) EDC: eCRF & eSource
Recent developments in eCRF and eSource systems.
04:45pm - 05:30pm(D363) Just Sponsors
A moderated discussion just for study sponsors: challenges and solutions.

Site Operations03:15pm - 03:55pm(E316) Subject Retention & Motivation
Now that they've signed up, how do you keep them involved?
04:00pm - 04:40pm(E355) The Investigator's Perspective
What investigators want...and what they want from you.
04:45pm - 05:30pm(E364) Just Sites
A moderated discussion just for study sites: challenges and solutions.

Special Topics03:15pm - 03:55pm(F356) Misconceptions about CROs
You've heard the complaints; now hear the reality.
04:00pm - 04:40pm(F354) Financial Prospects for the Clinical Research Industry
How will it affect your employment?
04:45pm - 05:30pm(F365) Just International
A moderated discussion just for people conducting international clinical research: challenges and solutions.

05:45pm - 07:15pm(X997) Networking Reception
07:30pm - 09:30pmDinner Parties
Join a group to dine at a local restaurant. (no host)

Tuesday, June 2

07:30am - 08:30amRegistration, Networking & Light Breakfast
08:30am - 10:00amTracks:

Contracts08:30am - 09:10am(A420) Clinical Trial CRADAs with the Department of Veterans Affairs
Finding common ground with industry
09:15am - 10:00am(A108) Don’t Forget the Other Contract Terms
There’s a reason we call it “boilerplate.” Twenty contract clauses you need to understand.

Budgets & Billing08:30am - 09:10am(B175) Tailoring the Budget to the Trial
Complexity, geography, therapeutic area, past performance, etc.
09:15am - 10:00am(B341) Standard of Care in Clinical Research
What does the data say?

Regulatory & Ethics08:30am - 09:10am(C145) Adverse Events & Unanticipated Problems
What just happened and what do we do about it?
09:15am - 10:00am(C146) Protocol Deviations & Violations
You have deviated from the protocol. Now what do you do?

Sponsor Operations08:30am - 09:10am(D306) Investigator Meetings for Investigators
Meeting the needs of investigators.
09:15am - 10:00am(D333) Targeting the Patient, Targeting the Message
Subject recruiting programs that hit home.

Site Operations08:30am - 09:10am(E337) Marketing & Business Development for Sites
Getting the word out and the studies in.
09:15am - 10:00am(E318) Protocol Feasibility Analysis for Sites
How to determine if a study is feasible for your site.

Special Topics08:30am - 09:10am(F257) Unraveling Complex Clinical Research Problems with Project Management
Getting a handle on complex systems before they become overwhelming.
09:15am - 10:00am(F348) Expanding a Site into Phase I Trials
What are the regulatory and practical requirements?

10:00am - 10:30amNetworking Break
10:30am - 12:00pmTracks:

Contracts10:30am - 11:10am(A212) CTAs in Canada
How do Canadian and U.S. clinical trial agreements and processes differ?
11:15am - 12:00pm(A330) CTAs Outside the United States
How do clinical trial agreements and processes differ outside the US?

Budgets & Billing10:30am - 11:10am(B118) Billing Compliance in Practice
Policies, processes and systems that will keep sites out of trouble.
11:15am - 12:00pm(B112) Making, Tracking & Collecting Payments
Quick, accurate payments: It takes two to tango.

Regulatory & Ethics10:30am - 11:10am(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.
11:15am - 12:00pm(C366) Battle of the Regulations: FDA vs. OHRP vs. ICH
What are the important differences?

Sponsor Operations10:30am - 11:10am(D308) Scaling Up Study Management
From small, simple and local to large, complex and global.
11:15am - 12:00pm(D181) Big Study No Subjects
Using root cause analysis to rescue studies that are not enrolling.

Site Operations10:30am - 11:10am(E174) Motivating Study Coordinators
What study coordinators want and how to get it for them.
11:15am - 12:00pm(E320) Training & Orienting Study Personnel
A structured approach to building competency.

Special Topics10:30am - 11:10am(F281) Risk-Based Computer Validation for Compliant Clinical Research
Complying with FDA guidance on computerized systems, 21 CFR Part 11, and GAMP5.
11:15am - 12:00pm(F326) Subject Data Privacy & Security
Practical aspects of protecting private subject information.

12:00pm - 01:15pmLunch: Birds of a Feather
Talk with people who share your role.
12:45pm - 02:00pm(X984) Clinical Research Contract Professional (CRCP) Certification Exam (1)
MAGI offers certification for clinical research contract professionals. Certification is available only at MAGI’s Clinical Trial Agreements and Budgets conferences. Attending the conference is excellent preparation for the certification exam. The exam is optional and open to everyone. There is an additional $369 fee to take the exam. More information.
01:15pm - 03:30pmTracks:

Contracts01:15pm - 01:55pm(A215) Understanding Your Insurance Policy
What is and is not covered may surprise you.
02:00pm - 02:40pm(A121) Standardizing Material Transfer Agreements
Applying Lessons from CTAs to MTAs and from MTAs to CTAs.

Budgets & Billing01:15pm - 01:55pm(B107) Investigator-Initiated Trial Budgets
How do the costs and budgets compare to industry-funded trials?
02:00pm - 02:40pm(B205) Inside the OIG’s Toolbox
Anti-kickback, false claims, beneficiary inducements, and more!

Regulatory & Ethics01:15pm - 01:55pm(C328) Regulations in Canada
How are they different than in the U.S.?
02:00pm - 02:40pm(C133) Conflicts of Interest
Study conflict management plans.
02:45pm - 03:30pm(C290) IRB Outsourcing: Faster Better, Cheaper?
Can a central IRB really do the job of a local IRB?

Sponsor Operations01:15pm - 01:55pm(D143) How to Stop Drowning in Data Queries
A collaborative approach to reducing queries and increasing quality.
02:00pm - 02:40pm(D342) Looking Behind the Data
Advanced techniques for monitoring data integrity.
02:45pm - 03:30pm(D311) Lessons Learned: Study Post Mortems
Let's not make that mistake again.

Site Operations01:15pm - 01:55pm(E321) What Parents Want in Pediatric Studies
Studies that appeal to parents and meet ethical guidelines.
02:00pm - 02:40pm(E322) Financial Management of Research Sites
The numbers matter.
02:45pm - 03:30pm(E346) Starting a Research Site from Scratch
Getting off on the right foot...and avoiding the potholes.

Special Topics01:15pm - 01:55pm(F171) Medical Device Regulations
How are drug and device regulations different?
02:00pm - 03:30pm(F116) NIH Grants & Budgets
Developing budgets for NIH grants that get funded.

03:30pm - 04:00pmNetworking Break
04:00pm - 05:00pm(P124) Stump the Experts
Clinical trial experts will try to answer your most perplexing questions.

Wednesday, June 3

07:15am - 08:00amRegistration, Networking & Light Breakfast
08:00am - 12:00pmWorkshops:
(W184) The Research Site Toolbox
Forms, charts & tips that make life easier
(W185) Writing Informed Consent Forms
How to write comprehensible informed consent forms that meet the regulatory and legal requirements. Plus: ICF translation and multimedia.
(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.
(W193) Budget Development & Negotiation for Investigative Sites
Effective budget negotiation requires preparation. The keys to preparation are knowing your costs and developing the infrastructure and methodology to consistently maximize revenues. Learn how to develop a practical system suitable for sites of any size. Workshop is also illuminating for research sponsors.
(W194) Practical Negotiation
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.
(W195) Clinical Research & Litigation Law
Clinical trial agreements are legal documents. In this workshop, learn about fundamental legal principles and how they apply to clinical trial agreements. Untangle the mysteries of contract law, litigation and other legal concepts that matter in clinical trial agreements. Workshop is designed for attorneys new to clinical research and non-attorneys.
(W196) Creating a Strategic Clinical Research Compliance Plan
A strategic compliance plan sets priorities, avoids fatal gaps, and sets forth a system of checks and balances to ensure compliance with laws and regulations governing good clinical practice and billing compliance. Join us in drafting part of a compliance plan for your organization that will pass muster with FDA and OIG. This workshop is applicable to research sites of all sizes, from private practice to academic medical center. Bring your pen, pencil or laptop.
(W198) Productive Site Monitor 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.

01:00pm - 02:15pm(X988) Clinical Research Contract Professional (CRCP) Certification Exam (2)
MAGI offers certification for clinical research contract professionals. Certification is available only at MAGI’s Clinical Trial Agreements and Budgets conferences. Attending the conference is excellent preparation for the certification exam. The exam is optional and open to everyone. There is an additional $369 fee to take the exam. More information.
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