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MAGI's Clinical Research Conference - 2010 West
Conference Program
Session dates and times may change.
Sunday, October 24 |
| 12:00pm - 05:00pm | Registration |
| 01:00pm - 05:00pm | Workshops:
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| Special Topics | (W179) Biostatistics for Mere Mortals
No calculators, no mathematical derivations, and no mysteries in this workshop. We will guide you through concepts like hypotheses, endpoints, sample size, study design, power, randomization, significance, common statistical tests, and data presentation. You will leave with the ability to talk intelligently with biostatisticians about the statistical concepts that underlie most clinical trials, including adaptive trials. (Related sessions: D207, E377) |
| Regulatory & Ethics | (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! (Related sessions: E346, F305, W335) |
| Contracts | (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… (Related sessions: A104, A108, A128, A202, A338, A339, B127, W192) |
| Regulatory & Ethics | (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. (Related sessions: B118, B205, B208, W178, W416, W429) |
| Special Topics | (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. (Related sessions: E835, F102, F370, W194, W204) |
| Special Topics | (W204) Building & Sustaining High-Performance Teams: The Art of Conflict Management
Assess your conflict management style and learn how to work effectively with team members who have different styles and strengths/weaknesses in decision-making, social skills, expertise, good will, etc. (Related sessions: E835, F102, F370, W194, W203) |
| Sponsor Operations | (W228) Clinical Research in India: Gaining the Advantages in a Rapidly Changing Environment
India's clinical trial landscape is rapidly evolving. This workshop will provide a step-by-step, interactive approach to navigate through the legendary diversity of India. You will gain an in-depth understanding of the regulators, regulations, regulatory nuances, ethics committees, clinical supply, documents, CROs, SMOs, and unique human subjects protection requirements. We will also discuss opportunities for translational clinical trials, proof-of-concept studies, and partnering and financing. |
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| 05:00pm - 06:00pm | Registration |
| 05:15pm - 06:45pm | Workshops:
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| Sponsor Operations | (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. |
| Regulatory & Ethics | (W178) Words to the Wise: Government Enforcement Activity in Research
Lessons learned the hard way. (Related sessions: B118, B205, B208, W199, W416, W429) |
| Special Topics | (W218) Challenges in Conducting Oncology Trials
Practical aspects of conducting oncology trials. (Related sessions: B361) |
| Regulatory & Ethics | (W335) Good Clinical Practice: Ask the Experts
An informal discussion with drug and device GCP experts. (Related sessions: W190) |
| Site Operations | (W419) Clinical Trial Offices: A Discussion about Challenges and Best Practices
A moderated discussion about academic medical center and other clinical trial offices. (Related sessions: E808) |
| Budgets & Billing | (W429) Self-Assessment and Monitoring of Billing Compliance
Ensure that your billing systems and processes are in compliance. (Related sessions: B118, B205, B208, W178, W199, W416) |
| Special Topics | (W820) Challenges in Conducting Medical Device Trials
Practical aspects of conducting device trials. (Related sessions: A260, C171) |
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| 07:00pm - 08:00pm | Informal Get-Together in the Laurel Court
Relax with old friends...and new ones. (cash bar) |
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Monday, October 25 |
| 07:15am - 08:15pm | Registration, Networking & Light Breakfast |
| 08:15am - 09:00am | (P101) Chairman's Opening Remarks
How to get the most out of the conference. |
| 09:00am - 10:00am | (P103) The Changing Regulatory Climate: How Scared Should We Be?
The pendulum is swinging toward a more active and stringent regulatory climate. What do the current trends portend for clinical research? (Related sessions: C138, C209, C326, C350, C814, F825) |
| 10:00am - 10:30am | Monday Morning Networking Break |
| 10:30am - 12:15pm | Tracks: |
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| Contracts | 10:30am - 12:15pm | (A104) Managing Risk with Contracts: Informed Consent, Subject Injury, Indemnification & Insurance
Injured subjects deserve proper care, but who pays for it? If something serious goes wrong, look here first. (Related sessions: A108, A128, A202, A338, A339, B127, W191, W192) |
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| Budgets & Billing | 10:30am - 11:15am | (B160) Budget Development & Analysis
How do sponsors develop study budgets? How do sites price their services? (Related sessions: A202, B161, B233, E322, W193) |
| 11:30am - 12:15pm | (B161) Budget Negotiation
Now that we know what we need, how do we get it? (Related sessions: A202, B160, B233, E322, W193) |
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| Regulatory & Ethics | 10:30am - 11:15am | (C814) Recent FDA Warning Letters & ORHP Determination Letters
What FDA & OHRP are telling us about their priorities and directions. (Related sessions: C138, C350, P103) |
| 11:30am - 12:15pm | (C326) Recent Developments in Subject Data Privacy & Security
HITECH Act changes to HIPAA. Genetic privacy and biobanking. (Related sessions: C209, F825, P103) |
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| Sponsor Operations | 10:30am - 11:15am | (D824) Project Planning & Metrics
Methods and metrics for managing clinical trials. (Related sessions: D214, D232) |
| 11:30am - 12:15pm | (D214) Planning & Executing Global Trials
Effective methods and metrics. (Related sessions: A212, A330, D232, D408, D418, D824, F102) |
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| Site Operations | 10:30am - 11:15am | (E315) Subject Recruiting by Sites
Planning & implementing effective recruiting programs. (Related sessions: E323, F406) |
| 11:30am - 12:15pm | (E377) Source Document Design
How to create efficient source document forms that capture the right data. (Related sessions: D207, D223, D327, D331, D381, E835, W179, W198) |
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| 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? (Related sessions: E346, W190) |
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| 12:15pm - 01:30pm | Lunch: Birds of a Feather
Talk with people who share your interests. |
| 01:30pm - 03:15pm | Tracks: |
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| Contracts | 01:30pm - 02:15pm | (A339) Intellectual Property Provisions
Sites are creating biosample repositories and developing biomarkers and other IP. (Related sessions: A104, A108, A128, A202, A338, B127, W191, W192) |
| 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? (Related sessions: A104, A108, A128, A202, A339, B127, W191, W192) |
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| Budgets & Billing | 01:30pm - 02:15pm | (B233) Above the Bottom Line: How Fees Vary by Site
The bottom line may be the same, but some sites charge more for this, others charge more for that. (Related sessions: A202, B160, B161, E322, W193) |
| 02:30pm - 03:15pm | (B208) Medicare Reimbursement for Clinical Trials
CMS rules and processes for billing Medicare. (Related sessions: B118, B205, W178, W199, W416, W429) |
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| Regulatory & Ethics | 01:30pm - 02:15pm | (C145) Adverse Events vs. Unanticipated Problems
Improve safety by reporting less. |
| 02:30pm - 03:15pm | (C133) Conflicts of Interest
How to deal with COIs in an evolving landscape. |
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| Sponsor Operations | 01:30pm - 02:15pm | (D207) Edit Checks, Data Queries, and Data Cleaning
Clean data in three steps. (Related sessions: E377, F376, F378, W179) |
| 02:30pm - 03:15pm | (D331) Site Monitoring with an Auditor's Eye
Seeing the forest for the trees. (Related sessions: D223, D327, D381, E377, E835, W198) |
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| Site Operations | 01:30pm - 02:15pm | (E323) Social Media for Subject Recruitment
Fad or fact? (Related sessions: E315, F406) |
| 02:30pm - 03:15pm | (E322) Financial Management of Research Sites
Improving the bottom line. (Related sessions: A202, B160, B161, B233, E318, E346, E426, E808, W193) |
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| Special Topics | 01:30pm - 02:45pm | (F378) Adverse Events: Classification and Data Quality
How to determine expectedness. Quality management of safety data. (Related sessions: D207, F376) |
| 02:30pm - 03:15pm | (F410) Technology Showcase
Forecasting with CTMS. Conflict of interest management. |
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| 03:15pm - 03:45pm | Monday Afternoon Networking Break |
| 03:45pm - 05:30pm | Tracks: |
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| Contracts | 03:45pm - 04:30pm | (A202) Sensible Payment Terms
Ten payment terms you need to know. (Related sessions: A104, A108, A128, A338, A339, B127, B160, B161, B233, E322, W191, W192, W193) |
| 04:45pm - 05:30pm | (A260) Just Medical Devices: A Moderated Discussion
Just for people conducting clinical research with medical devices: challenges and solutions. (Related sessions: C171, W820) |
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| Budgets & Billing | 03:45pm - 04:30pm | (B118) Billing Compliance in Practice
Coverage analysis benefits and logistical challenges. (Related sessions: B205, B208, W178, W199, W416, W429) |
| 04:45pm - 05:30pm | (B361) Just Oncology: A Moderated Discussion
Just for people conducting clinical research in oncology: challenges and solutions. (Related sessions: W218) |
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| Regulatory & Ethics | 03:45pm - 04:30pm | (C366) Battle of the Regulations: FDA vs. OHRP vs. ICH
What are the important differences? |
| 04:45pm - 05:30pm | (C362) Just CROs: A Moderated Discussion
Just for CROs: challenges and solutions. |
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| Sponsor Operations | 03:45pm - 04:30pm | (D381) Adaptive Site Monitoring
Save 50% of field monitoring costs with a risk-based approach to quality. (Related sessions: D223, D327, D331, E377, E835, W198) |
| 04:45pm - 05:30pm | (D363) Just Sponsors: A Moderated Discussion
Just for study sponsors: challenges and solutions. |
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| Site Operations | 03:45pm - 04:30pm | (E426) Integrating Research into the Clinical Setting
How clinical practice and clinical research can play together. (Related sessions: E318, E322, E346, E808) |
| 04:45pm - 05:30pm | (E364) Just Sites: A Moderated Discussion
Just for study sites: challenges and solutions. |
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| Special Topics | 03:45pm - 04:30pm | (F370) What Sites Want from Sponsors
How to become a "sponsor of choice." (Related sessions: A217, E835, F102, F380, W194, W203, W204) |
| 04:45pm - 05:30pm | (F365) Just International: A Moderated Discussion
Just for people conducting international clinical research: challenges and solutions. |
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| 05:30pm - 07:00pm | (X997) Networking Reception in Exhibit Hall |
| 07:30pm - 09:30pm | Dinner Parties
Join a group to dine at a local restaurant. (no host) |
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Tuesday, October 26 |
| 07:30am - 08:30am | Registration, Networking & Light Breakfast |
| 08:30am - 10:15am | Tracks: |
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| 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. (Related sessions: A104, A128, A202, A338, A339, B127, W191, W192) |
| 09:30am - 10:15am | (A217) Clinical Trial Agreements for Investigator-Initiated Trials
What agreements look like when the site comes asking. (Related sessions: F370, F380) |
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| Budgets & Billing | 08:30am - 09:15am | (B112) Tracking & Collecting Payments
Do the work; collect the payment. |
| 09:30am - 10:15am | (B116) Introductory NIH Grants & Budgets
Understanding and recovering your costs. (Related sessions: B125) |
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| Regulatory & Ethics | 08:30am - 09:15am | (C340) Streamlining the IRB Process
Speed and efficiency without sacrificing quality. |
| 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. (Related sessions: C350, C814, P103) |
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| Sponsor Operations | 08:30am - 09:15am | (D327) eMonitoring: On-site and Remote
eTools for site visits. Techniques for remote eMonitoring. (Related sessions: D223, D331, D381, E377, E835, W198) |
| 09:30am - 10:15am | (D232) Conducting Studies on a Shoestring
Where you can trim the fat...and can't. (Related sessions: D214, D824) |
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| Site Operations | 08:30am - 09:15am | (E422) Motivating & Evaluating Study Coordinators
Getting the most out of your people. |
| 09:30am - 10:15am | (E835) Working with Difficult Investigators
Resolving issues and misunderstandings. (Related sessions: D223, D327, D331, D381, E377, F102, F370, W194, W198, W203, W204) |
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| Special Topics | 08:30am - 09:15am | (F380) Practical Investigator Initiated Trials
How to manage and conduct IITs: Who does what how. (Related sessions: A217, F370) |
| 09:30am - 10:15am | (F825) Healthcare Reform Update: Opportunities and Challenges
The practical implications for research sponsors, sites and CROs. (Related sessions: C209, C326, P103) |
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| 10:15am - 10:45am | Tuesday Morning Networking Break |
| 10:45am - 12:30pm | Tracks: |
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| Contracts | 10:45am - 11:30am | (A212) CTAs in Canada
How do Canadian and U.S. clinical trial agreements and processes differ? (Related sessions: A330, D214, D408, D418, F102) |
| 11:45am - 12:30pm | (A330) CTAs Outside the U.S.
How do clinical trial agreements and processes look outside the U.S.? (Related sessions: A212, D214, D408, D418, F102) |
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| Budgets & Billing | 10:45am - 11:30am | (B125) Advanced NIH Grants & Budgets
Understanding and recovering your costs. (Related sessions: B116) |
| 11:45am - 12:30pm | (B205) Inside the OIG’s Toolbox
Anti-kickback, false claims, beneficiary inducements, and more! (Related sessions: B118, B208, W178, W199, W416, W429) |
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| Regulatory & Ethics | 10:45am - 11:30am | (C350) FDA Inspections: Handling the Consequences
Dealing with the aftermath of an FDA inspection at a sponsor or site. (Related sessions: C138, C814, P103) |
| 11:45am - 12:30pm | (C209) Recent Developments in Human Subjects Protection Regulation
And, where are we going? (Related sessions: C326, F825, P103) |
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| Sponsor Operations | 10:45am - 11:30am | (D219) Improving the Study Startup Process with Sites
Decreasing cycle times and increasing research site satisfaction. |
| 11:45am - 12:30pm | (D223) Site Visit Follow-Up
Notes-to-file, visit reports, and corrective action plans. (Related sessions: D327, D331, D381, E377, E835, W198) |
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| Site Operations | 10:45am - 11:30am | (E211) Records Rescue: Cleaning Up After a Problematic Study Coordinator
When a study coordinator leaves you holding the bag. |
| 11:45am - 12:30pm | (E318) Protocol Feasibility Analysis for Sites
How to determine if a study is feasible for your site. (Related sessions: E322, E346, E426, E808) |
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| Special Topics | 10:45am - 11:30am | (F102) Working Across Cultures
Effective collaboration requires good communications that consider the other party's national culture. Colombia, India and Jordan. (Related sessions: A212, A330, D214, D408, D418, E835, F370, W194, W203, W204) |
| 11:45am - 12:30pm | (F215) Understanding Your Insurance Policy
What is and is not covered may surprise you. |
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| 12:30pm - 01:45pm | Lunch: Cities, States & Countries
Talk with people from your geographical area. |
| 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: |
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| Contracts | 01:45pm - 02:30pm | (A128) Recent Developments in Clinical Trial Agreements
How are CTAs changing? (Related sessions: A104, A108, A202, A338, A339, B127, W191, W192) |
| 02:45pm - 03:30pm | (A420) Clinical Trial CRADAs with the Department of Veterans Affairs
Background and how to best work with the VA. |
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| Budgets & Billing | 01:45pm - 02:30pm | (B357) Private Insurance Reimbursement
Pre-authorization processes and state mandates to cover routine costs. |
| 02:45pm - 03:30pm | (B127) After the CTA is Signed: Ad Hoc Charges and Contract Amendments
Which changes and charges are acceptable and how to implement them. (Related sessions: A104, A108, A128, A202, A338, A339, W191, W192) |
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| Regulatory & Ethics | 01:45pm - 02:30pm | (C818) Extreme Informed Consent
ICFs without the padding. Emergency informed consent. |
| 02:45pm - 03:30pm | (C171) Medical Device Regulations
ISO's proposed adverse event reporting rules. How drug and device regulations differ. (Related sessions: A260, W820) |
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| Sponsor Operations | 01:45pm - 02:30pm | (D408) Are Sponsors Re-evaluating Globalization of Clinical Sites?
Has globalization run its course, or will it accelerate? (Related sessions: A212, A330, D214, D418, F102) |
| 02:45pm - 03:30pm | (D418) Country Selection in Global Trials
Demographics, infrastructure, logistics and more. (Related sessions: A212, A330, D214, D408, F102) |
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| Site Operations | 01:45pm - 02:30pm | (E346) Starting a Research Site from Scratch
Getting off on the right foot...and avoiding the potholes. (Related sessions: E318, E322, E426, E808, F305, W190) |
| 02:45pm - 03:30pm | (E808) Starting & Running a Clinical Trials Center
A simple centralized online study tracking & workflow system. A decentralized model. (Related sessions: E318, E322, E346, E426, W419) |
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| Special Topics | 01:45pm - 02:30pm | (F376) Quality Management from Writing to Reading
Document management. Internal audits. (Related sessions: D207, F378) |
| 02:45pm - 03:30pm | (F406) Electronic Health Records (EHRs) and Clinical Research
EHR capabilities for clinical research. Part 11 compliance. (Related sessions: E315, E323) |
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| 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 - 06:45pm | Informal Get-Together at the Top of the Mark
Relax with old friends...and new ones. (cash bar) |
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Wednesday, October 27 |
| 07:15am - 08:00am | Registration, Networking & Light Breakfast |
| 08:00am - 12:00pm | Workshops:
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| Site Operations | (W184) The Research Site Toolbox
Fifty forms, charts & tips that make life easier. |
| Contracts | (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. (Related sessions: A104, A108, A128, A202, A338, A339, B127, W191) |
| Budgets & Billing | (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. Demonstrate value and conduct effective negotiations. Workshop is also illuminating for research sponsors. (Related sessions: A202, B160, B161, B233, E322) |
| Special Topics | (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. (Related sessions: E835, F102, F370, W203, W204) |
| Special Topics | (W195) Clinical Research Law and Litigation: Preventing and Resolving Subject Lawsuits
Learn about legal concepts, such as tort claims, negligence, breach of duty, battery, misrepresentation, reckless conduct, emotional distress, denial of human dignity, joint and several liability, and proximate cause, before you face them in a court of law. Workshop is designed for attorneys new to clinical research and non-attorneys. |
| Sponsor Operations | (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. (Related sessions: D223, D327, D331, D381, E377, E835) |
| Regulatory & Ethics | (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. (Related sessions: B118, B205, B208, W178, W199, W429) |
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| 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. |
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