Sunday, October 4 |
| 12:00pm - 05:00pm | Registration |
| 01:00pm - 05:00pm | Workshops:
|
| (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 - 06:00pm | Registration |
| 05:15pm - 06:45pm | Workshops:
|
| (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. |
| (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. |
| (W204) Building & Sustaining High-Performance Teams
Project teams, matrix teams, cross-organizational teams. Learn how to create teams, how to build trust, the leader's role, and effective team problem solving. |
|
|
| 07:00pm - 08:00pm | Informal Get-Together in the Odysea Lounge
Relax with old friends...and new ones. (cash bar) |
|
Monday, October 5 |
| 07:30am - 08:30pm | Registration, Networking & Light Breakfast |
| 08:30am - 09:00am | (P101) Chairman's Opening Remarks
How to get the most out of the conference. |
| 09:00am - 10:00am | (P825) Healthcare Reform: Opportunities and Challenges for the Clinical Research Enterprise
The practical implications for research sponsors, sites and CROs. |
| 10:00am - 10:30am | Monday Morning Networking Break |
| 10:30am - 12:15pm | Tracks: |
|
|
| Contracts | 10:30am - 12:15pm | (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 & Billing | 10:30am - 11:15am | (B160) Budget Development & Analysis
How do sponsors develop study budgets? How do sites price their services? |
| 11:30am - 12:15pm | (B161) Budget Negotiation
Now that we know what we need, how do we get it? |
|
|
| Regulatory & Ethics | 10:30am - 11:15am | (C344) Vulnerable Subjects
What the regulations don't say. |
| 11:30am - 12:15pm | (C132) Working with IRBs - The IRB's Perspective
You can do it the hard way or the easy way. |
|
|
| Sponsor Operations | 10:30am - 11:15am | (D214) Planning & Executing Global Trials
Effective methods and metrics. |
| 11:30am - 12:15pm | (D342) Advanced Site Monitoring Techniques
Looking behind the data. |
|
|
| Site Operations | 10:30am - 11:15am | (E312) Quality Management for Sites
Delivering quality research before site monitoring. |
| 11:30am - 12:15pm | (E315) Subject Recruiting by Sites
Planning & implementing effective recruiting programs. |
|
|
| Special Topics | 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? |
|
|
| 12:15pm - 01:30pm | Monday Lunch with Speakers
Join a speaker for lunch. |
| 01:30pm - 03:15pm | Tracks: |
|
|
| Contracts | 01:30pm - 02:15pm | (A339) Intellectual Property Provisions
Sites are creating biosample repositories and developing biomarkers and other IP. |
| 02:30pm - 03:15pm | (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 & Billing | 01:30pm - 02:15pm | (B823) Pricing Patterns & Trends
Where are site fees high? Where are they low? How are they changing? |
| 02:30pm - 03:15pm | (B208) Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare. |
|
|
| Regulatory & Ethics | 01:30pm - 02:15pm | (C133) Conflicts of Interest
The evolving landscape. |
| 02:30pm - 03:15pm | (C371) AAHRPP Accreditation for your Human Research Protection Program
Using the accreditation process to ensure high quality research. |
|
|
| Sponsor Operations | 01:30pm - 02:15pm | (D353) Keeping Projects on Track with Earned Value Management
How much have we really accomplished? |
| 02:30pm - 03:15pm | (D372) Subject Recruitment Advertising
Can ads be both effective and ethical? |
|
|
| Site Operations | 01:30pm - 02:15pm | (E352) Electronic Media in Subject Recruitment
Ten ways to recruit subjects through the Internet. |
| 02:30pm - 03:15pm | (E322) Financial Management of Research Sites
The numbers matter. |
|
|
| Special Topics | 01:30pm - 02:15pm | (F102) Working Across Cultures
Brazil, India and Israel. Effective collaboration requires good communications that consider the other party's national and organizational culture. |
| 02:30pm - 03:15pm | (F410) Technology Showcase
Conflict of interest management; site stress tests. |
|
|
| 03:15pm - 03:45pm | Monday Afternoon Networking Break |
| 03:45pm - 05:30pm | Tracks: |
|
|
| Contracts | 03:45pm - 04:30pm | (A202) Sensible Payment Terms
Ten payment terms you need to know. |
| 04:45pm - 05:30pm | (A260) Just Medical Devices: A Moderated Discussion
Just for people conducting clinical research with medical devices: challenges and solutions. |
|
|
| Budgets & Billing | 03:45pm - 04:30pm | (B118) Billing Compliance in Practice
Policies, processes and systems that will keep sites out of trouble. |
| 04:45pm - 05:30pm | (B361) Just Oncology: A Moderated Discussion
Just for people conducting clinical research in oncology: challenges and solutions. |
|
|
| Regulatory & Ethics | 03:45pm - 04:30pm | (C146) Protocol Deviations & Violations
You have deviated from the protocol. Now what do you do? |
| 04:45pm - 05:30pm | (C362) Just CROs: A Moderated Discussion
Just for CROs: challenges and solutions. |
|
|
| Sponsor Operations | 03:45pm - 04:30pm | (D304) Road Warriors: Advanced Travel Tips
Life on the road that isn't a living hell. |
| 04:45pm - 05:30pm | (D363) Just Sponsors: A Moderated Discussion
Just for study sponsors: challenges and solutions. |
|
|
| Site Operations | 03:45pm - 04:30pm | (E337) Marketing & Business Development for Sites
Getting the word out and the studies in. |
| 04:45pm - 05:30pm | (E364) Just Sites: A Moderated Discussion
Just for study sites: challenges and solutions. |
|
|
| Special Topics | 03:45pm - 04:30pm | (F356) Misconceptions about CROs
You've heard the complaints; now hear the reality. |
| 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 - 09:30pm | Dinner Parties
Join a group to dine at a local restaurant. (no host) |
|
Tuesday, October 6 |
| 07:30am - 08:30am | Registration, Networking & Light Breakfast |
| 08:30am - 10:15am | Tracks: |
|
|
| Contracts | 08:30am - 09:15am | (A108) Don’t Forget the Other Contract Terms
There’s a reason we call it “boilerplate.” Twenty contract clauses you need to understand. |
| 09:30am - 10:15am | (A217) Clinical Trial Agreements for Investigator-Initiated Trials
What agreements look like when the site comes asking. |
|
|
| Budgets & Billing | 08:30am - 09:15am | (B117) Collecting Payments; Financial Viability of Sponsors
Do the work; collect the payment. |
| 09:30am - 10:15am | (B347) Budgeting for International Subject Recruiting
Different countries – different costs. |
|
|
| Regulatory & Ethics | 08:30am - 09:15am | (C145) Adverse Events vs. Unanticipated Problems
Improve safety by reporting less. |
| 09:30am - 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. |
|
|
| Sponsor Operations | 08:30am - 09:15am | (D824) Project Planning & Metrics
Methods and metrics for managing clinical trials. |
| 09:30am - 10:15am | (D421) Applying Healthcare Data to Site Selection and Patient Recruitment
Making better use of available data sources. |
|
|
| Site Operations | 08:30am - 09:15am | (E355) The Investigator's Perspective
What investigators want...and what they want from you. |
| 09:30am - 10:15am | (E835) Working with Difficult Investigators
Resolving issues and misunderstandings. |
|
|
| Special Topics | 08:30am - 09:15am | (F358) Fixing a Broken SOP System
Design and maintenance. |
| 09:30am - 10:15am | (F420) Clinical Trial CRADAs with the Department of Veterans Affairs
Finding common ground with industry. |
|
|
| 10:15am - 10:45am | Tuesday Morning Networking Break |
| 10:45am - 12:30pm | Tracks: |
|
|
| Contracts | 10:45am - 11:30am | (A212) CTAs in Canada
How do Canadian and U.S. clinical trial agreements and processes differ? |
| 11:45am - 12:30pm | (A330) CTAs Outside the United States
How do clinical trial agreements and processes differ outside the US? |
|
|
| Budgets & Billing | 10:45am - 11:30am | (B205) Inside the OIG’s Toolbox
Anti-kickback, false claims, beneficiary inducements, and more! |
| 11:45am - 12:30pm | (B357) Private Insurance Reimbursement
Pre-authorization processes and state mandates. |
|
|
| Regulatory & Ethics | 10:45am - 11:30am | (C350) FDA Inspections: Handling the Consequences
Dealing with the aftermath of an FDA inspection. |
| 11:45am - 12:30pm | (C366) Battle of the Regulations: FDA vs. OHRP vs. ICH
What are the important differences? |
|
|
| Sponsor Operations | 10:45am - 11:30am | (D219) Improving the Site Startup Process
Decreasing cycle times and increasing research site satisfaction. |
| 11:45am - 12:30pm | (D413) How Sponsors Use Study Data
What happens to the data that sites collect. |
|
|
| Site Operations | 10:45am - 11:30am | (E422) Motivating & Evaluating Study Coordinators
Getting the most out of your people. |
| 11:45am - 12:30pm | (E318) Protocol Feasibility Analysis for Sites
How to determine if a study is feasible for your site. |
|
|
| Special Topics | 10:45am - 11:30am | (F414) Study Brokers
How to use study brokers to find sites and studies. |
| 11:45am - 12:30pm | (F182) Stem Cell Clinical Research Oversight
Impact of the Proposed NIH Guidelines on IRB/IECs and SCRO/ESCROs |
|
|
| 12:30pm - 01:45pm | Tuesday Lunch: Birds of a Feather
Talk with people who share your interests. |
| 01:15pm - 02:30pm | (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. Also offered on Wednesday. There is an additional $369 fee to take the exam. More information. |
| 01:45pm - 03:30pm | Tracks: |
|
|
| Contracts | 01:45pm - 02:30pm | (A215) Understanding Your Insurance Policy
What is and is not covered may surprise you. |
| 02:45pm - 03:30pm | (A345) Flowcharting the Process of Contracting with Sites
Develop, implement, train and maintain efficient contracting and other processes. |
|
|
| Budgets & Billing | 01:45pm - 03:30pm | (B116) NIH Grants & Budgets: Applications & Compliance
Developing budgets for NIH grants that get funded and comply with the rules. |
|
|
| Regulatory & Ethics | 01:45pm - 02:30pm | (C326) Recent Developments in Subject Data Privacy & Security
HITECH Act changes to HIPAA. Genetic privacy and biobanking. |
| 02:45pm - 03:30pm | (C171) Device vs. Drug Regulations
How are device and drug regulations different? |
|
|
| Sponsor Operations | 01:45pm - 02:30pm | (D418) Country Selection in Global Trials
Demographics, infrastructure, logistics and more. |
| 02:45pm - 03:30pm | (D359) Community Clinics: The Untapped Resource for Subjects
Recruiting subjects and conducting trials in community and free clinics. |
|
|
| Site Operations | 01:45pm - 02:30pm | (E346) Starting a Research Site from Scratch
Getting off on the right foot...and avoiding the potholes. |
| 02:45pm - 03:30pm | (E808) Starting & Running a Clinical Trials Office
Delivering value in a complex environment; a simple clinical trial management system. |
|
|
| Special Topics | 01:45pm - 02:30pm | (F280) 2009 Subject & Physician Survey Results
Understanding the relationship to maximize study referrals. |
| 02:45pm - 03:30pm | (F209) Recent Developments in Human Subjects Protection Regulation
And, where are we going? |
|
|
| 03:30pm - 04:00pm | Tuesday Afternoon Networking Break |
| 04:00pm - 05:00pm | (P124) Stump the Experts
Clinical trial experts will try to answer your most perplexing questions. |
| 05:15pm - 06:30pm | Informal Get-Together at the Vela Fire Pit
Relax with old friends...and new ones. (cash bar) |
|
Wednesday, October 7 |
| 07:15am - 08:00am | Registration, Networking & Light Breakfast |
| 08:00am - 12:00pm | Workshops:
|
| (W184) The Research Site Toolbox
50 forms, charts & tips that make life easier. |
| (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: 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. |
| (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. |
| (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. |
| (W206) Site Questionnaire Drafting Session
Help create MAGI's new inventory of standardized site selection questionnaire questions. Bring copies of site questionnaires. This workshop is a working session. It runs from 8:15am - 10:00am. |
|
|
| 12:45pm - 02:00pm | (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. Also offered on Tuesday. There is an additional $369 fee to take the exam. More information. |
