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Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

Clinical Research 101- Lifecycle of a Clinical Trial

Date and Time

Thursday, November 10th, 2016
8:00 AM - 4:30 PM CDT

Location

3M Center
Building 235 Auditorium
Maplewood, MN
United States

Description

MEMBERS $299 / NON MEMBERS $399

The MAA Clinical 101 program features a one-day session on clinical trial basics and best practices in clinical research trials. Seasoned industry professionals will present the clinical study lifecycle from early concept to final report, highlighting key focus areas:  patient safety, data integrity, and compliance assurance.  This lively day of learning includes an overview of regulations and real-world examples of how to put those foundations into practice for a successful trial.


Agenda (SEE SPEAKER BIOS HERE):

7:30 - 8:00 AM   -   Registration / Networking

8:00 - 8:15 AM   -   Welcome / Introductions

Clinical Trial Process Overview

8:15 - 9:00 AM   -   Clinical Research History and Good Clinical Practices (GCP)

Sarah Moeller, The Greenlight Group, LLC

9:00 - 9:30 AM   -   Clinical Trial Relevance in the Product Life Cycle

Paula Kamman, RCRI

Clinical Trial Planning

9:30 - 10:00 AM   -   Clinical Trial Design and Protocol Development: Critical Concepts for Effective and Efficient Trials

Mary Kay Sobcinski, Sr. Principal Advisor, Clinical Sciences, RCRI

10:00 - 10:15 AM   -   Break

Clinical Trial Planning, continued...

10:15 - 11:15 AM   -   Study Activity Overview: Key Milestones for Trial Development, Conduct and Reporting

Mark Kay Sobcinski, Sr. Principal Advisor, Clinical Sciences, RCRI

11:15 - 11:45 AM   -   Data Management - Case Report Form and Database Development

Jill Tufano, Fortress Medical Systyems, Inc.

11:45 AM - 12:45 PM   -   Luncheon

Clinical Trial Start-Up and Execution

12:45 - 1:45 PM   -   Site Selection / Qualification - Site Inititaion and Training.

Barb Duerr, 3M

1:45 - 2:15 PM   -   Sponsor Responsibilities - Investigator / Site Responsibilities, Delegations of Authority. Vendor Selection and Management: Core Labs, CROs, CEC/DSMB

Kari Loing, ValenTx

2:15 - 2:30 PM   -   Break

Clinical Trial Implementation

2:30 - 3:30 PM   -   Monitoring - Adverse Events and Safety Reports

Paul Below, P. Below Consulting, Inc.

Quality Control and Quality Assurance

3:30 - 4:00 PM   -   Post Market Surveillance / Risk Analysis - Audits - FDA and Competant Authority Inspections

Sarah Moeller, The Greenlight Group, LLC

4:00 - 4:30 PM   -   Clinical Trial Lessons Learned - Common Pitfalls and Risk Mitigation (Panel)

Panel