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Online

Clinical Investigator: eLearning Program

Overview: This eLearning program is designed to provide a practical, realistic context in which to help clinical research professionals learn about conducting clinical trials. Using an interactive case study, the program follows the activities of a fictitious clinical investigator and his staff as they conduct a clinical trial for a fictitious drug.

Purchase both Modules and Save $100.

Clinical Investigator: Module 1 - Study Preparation and Initiation

Module 1 deals with the activities that occur before a clinical trial begins: study preparation and study initiation.

Clinical Investigator: Module 2 - Conducting The Study

Module 2 focuses on activities that occur during the trial.

April

April 7-10, 2014

Design of Medical Devices Conference

The Commons Hotel & McNamara Alumni Center
Minneapolis, Minnesota
http://www.dmd.umn.edu

Registration is now open for the Design of Medical Devices Conference (DMD), the world's premier medical devices conference April 7-10, 2014 held at The Commons Hotel and McNamara Alumni Center in Minneapolis, MN. The DMD Conference brings together medical device designers, manufacturers, researchers, and representatives from academia and the public sector.

Conference Overview
The University of Minnesota’s Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering, and the Academic Health Center presents the 13th Annual Design of Medical Devices Conference, April 7-10, 2014. The world's largest medical device conference will be held at The Commons Hotel & McNamara Alumni Center, located on the University of Minnesota Twin Cities Campus.

Conference Goals

  • Provide a national forum to bring together world-class medical device designers, researchers, manufacturers, and the public sector to share perspectives and innovations in medical device design
  • Showcase the University of Minnesota as a leader in the medical device community
  • Raise funds from corporate sponsorships to support medical device education at the University of Minnesota

Register today! Early Bird Deadline is March 23, 2014. Complete registration information can be found at http://www.dmd.umn.edu/registration.html

For more information, please visit www.dmd.umn.edu or contact dmdconf@umn.edu

April 10-11, 2014

Clinical Study Teamwork Building Effective Partnerships

Embassy Suites, Raleigh-Durham/RTP, NC

iiBIG’s Clinical Study Teamwork: Building Effective Partnerships conference will feature clinical research professionals who will share their experiences, insights, and best practice outcomes in clinical operations. Attendees will learn lessons for improvement and development of current and new clinical operation strategies. Participants will investigate a range of critical issues, including discussion of the risks involved in meeting timelines/deliverables, and survey the landscape of risk mitigation. Finally, this event will serve as the main platform for participants to build constructive networks and collaborative research and development worldwide.

The conference will feature a keynote presentation on “Clinical Collaborations: Driving a More Efficient R&D Paradigm” presented by Ken Getz, Founder and Owner, CenterWatch; Director, Sponsored Research Programs, Tufts CSDD; and Chairman, CISCRP.

Other agenda topics to be covered include:

  • Building Effective Partnerships
  • Clinical Research Site Operations/Site Management Training for CRA/CRC and Investigators
  • Clinical Research Operations: Effective Strategies for Clinical Operations Teams
  • Proxy Consent-Children and The Cognitively Impaired
  • Managing Risks in Outsourcing Clinical Trials
  • How Sites Can Track Their Own Performance Metrics to Be Successful
  • Improving the Study Start-Up Process with the Clinical Sites
  • It’s All About the Data: Source Documentation
  • CTA/Budget Development and Negotiation with the Clinical Sites
  • Silos in Recruitment-Breaking Down the Barriers Between Sponsor/CRO/Sites
  • How to mplement Risk Based Monitoring into your Clinical Program
  • Clinical Research Site Operations and Site Management Training for CRA and CRC and Investigators
  • Clinical Research Operations: Effective Strategies for Clinical Operation Teams
  • Sponsor Audits and FDA Inspections at the Clinical Site
  • Partnership Considerations for the Small Virtual Company
  • Identifying Why Trials Fail and Proven Preventive Measures that Work

Use Discount CW200 and Save Extra $200 on Registration. For more information and to register, go to http://www.iibig.com/ClinicalStudy or contact info@iibig.com.

April 11, 2014

Human Research Protection: Navigating the Currents of Contemporary Research

Westin Diplomat Resort & Spa
Hollywood, Florida
http://www.HRPConference.com

Our 2014 conference promises to be an engaging and informative event for members of the research community. Conference sessions will address issues of critical importance to human subject protections, including:

  • Stem Cell Research: What Is the Right Way and Acceptable to the FDA?
  • Nutraceutical Research: Lessons Learned and Expectations of the FDA
  • Conflicts of Interest in Biomedical Research: Identification and Management
  • HRPP Accreditation: Advantages and Disadvantages
  • New Models for Clinical Research in Community Affiliate Institutions: Experiments for the Future

This conference is accredited for 5.25 AMA PRA Category 1 credits, 5.25 ANCC contact hours and 5.25 pharmacy credits. Accreditation certificates are available for all attendees.

For more information, please visit www.HRPConference.com or contact Dora Allen at dallen@sairb.com.

April 26-April 29, 2014

ACRP 2014 Global Conference & Exhibition

Henry B. Gonzalez Convention Center
San Antonio, Texas
http://www.acrp2014.org

ACRP's Global Conference & Exhibition is uniquely focused on supporting the professional growth and development of individuals conducting clinical trials through education, exchange, and peer-to-peer engagement.

Through expert-delivered educational sessions, you will hear updates on best practices, regulatory developments, industry trends and tips and tools all of which allow you to own your success in clinical research.

The conference features more than 120 educational sessions and workshops, along with several opportunities for networking with fellow clinical research professionals. To register, or for more information, please visit www.acrp2014.org

May

May 4-7, 2014

MAGI's Clinical Research Conference - 2014 East

The Loews Hotel - Philadelphia
http://www.magiworld.org

Operations - Regulatory Compliance - Contracts - Budgets - Quality

  • 90+ sessions and workshops in seven tracks: sponsor operations, site operations, regulatory compliance, contracts, budgets & billing, quality and special topics.
  • Exceptional networking with a broad (but not too broad) range of experienced clinical research professionals
  • 22+ continuing education contact hours (CME, CNE, CLE, CCB, other)
  • Clinical Research Contract Professional (CRCP) certification exam

Well over 500 people will attend. If you are a clinical research novice or veteran; with a study sponsor, research site, or CRO; in a corporate, academic or other organization; you will find a coherent and comprehensive program that focuses on your current needs for applicable information. MAGI sessions and workshops emphasize practical tips based on real-life examples, with lots of interaction. Please join us in Philadelphia.

The conference is structured to facilitate networking and promote lasting relationships. About half of the attendees have leadership roles like CEO, vice president, or director. Over two-thirds have five or more years of clinical research experience. Study sponsors are split about 70% biopharma and 30% medical device. Sites are almost evenly split between (a) academic medical centers, (b) health systems and community hospitals, and (c) independent sites and networks. As a result, networking is very productive. Meet people from all sides of the table in an open, friendly and energetic environment. Read an article. Speakers are generally very accessible during the conference. Help us build the clinical research community!

Basic registration provides an "all access pass" to all meeting activities. You may attend any session in any track, workshops, and all conference networking functions -- luncheons, networking breaks, evening reception, and more! Register today!

MAGI meetings are the exclusive venue for Clinical Research Contract Professional (CRCP) certification exams. Demonstrate your professional competence to your employer, colleagues, negotiating partners, and yourself.

Over 22 contact hours are available for CME continuing medical education, CNE/CEU continuing nursing education, CLE continuing legal education, CCB (CHC,CCEP,CHRC,CHPC), ACRP (CCRA,CCRC,CCTI,CPI), CCIP (CIP), IAOP (COP), ICR (CPD), NAIM (CIM), NALA (CLA,CP), NCCPA (CME), NGMA (CGMS), PMI (PMP,PgPM), PMI (CMOM), PRIM&R (CIP), RACC (RAC), SoCRA(CCRP), and SQA (RQAP). Learn more.

About MAGI. MAGI is streamlining clinical research by standardizing best practices for clinical research operations, business and regulatory compliance. Our 10,000+ members represent clinical research sponsors, sites and CROs. "MAGI" is pronounced with "G" as in Georgia and "I" as in Ireland. (Hear it pronounced.) Norman M. Goldfarb, CRCP, founder and chairman of MAGI, is organizing and chairing this conference. Learn more.

MAGI is operated by First Clinical Research LLC, a for-profit company.

Learn more: http://www.magiworld.org/events/2014E/registration.php

May 5-6, 2014

Chief Medical Officer East

The Conference Forum’s First Annual Chief Medical Officer Summit for Emerging Life Science Companies is delighted to present a truly distinctive and interactive event for CMOs. We are grateful to Dr. Elizabeth Stoner, Managing Director, MPM Capital, for suggesting the idea and to our CMO advisers for their insights on content and agenda development.

We are Dedicated to Accomplishing Two Goals

  1. To bring together CMO executives to address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital, working and meeting with investors and strategizing for appropriate exits.
  2. To create a network of CMOs from small to mid-size life science companies to share ideas, solutions and support.
Who Should Attend

The conference is designed specifically for CMOs, but certainly Heads of R&D, Clinical Operations/Development/Outsourcing, and Vice Presidents of Medical Affairs would also greatly benefit from attending the program. Clinical service providers and investors are encouraged to attend as conversations with CMOs are very much welcomed.

Learn more: http://theconferenceforum.org/conferences/chief-medical-officer-summit/overview/

May 6-7, 2014

2014 Avoca Quality Consortium Summit

The Westin Princeton at Forrestal Village
Princeton, NJ

Mark your calendar for the 2014 Avoca Quality Consortium Summit gathering of pharma, biotech, and CRO quality, outsourcing and operational professionals.

May 6: Members-only workshops(Open only to Members of The Avoca Group Quality Consortium. Membership opportunities are still available - for details, please visit The Avoca Quality Consortium)

May 7: Industry-wide symposium featuring top executives from leading pharmaceutical, biotech and CRO companies.

Learn more here.

May 7-9, 2014

Evolution Summit 2014 - Innovation and Reform in Clinical Trials

Eau Palm Beach Resort & Spa
Palm Beach, FL

The primary objective of the Evolution Summit is to explore the key aspects and issues related to medical device R&D best practices. The summit's program topics have been pinpointed and validated by the R&D community as the top critical issues they face. Key issues for 2014 include:

  • Prospects for Personalized Medicines in the Emerging Markets
  • Clinical Innovation in the Development of Precision Medicines
  • Innovation and Reform in Clinical Trials
  • Achieving Realistic Project Timelines Through Strategic Partnerships and Alliances
  • Determining Appropriate Endpoints for Clinical Trials: A Multidimensional Approach
  • Clinical Trials in Emerging Markets: Setting the Stage for Global Trials
  • Accelerating Clinical Trial Patient Recruitment and Retention
  • Pharmacogenomics in Early-Phase Clinical Trials

LEADING SOLUTIONS & SERVICES

Between session presentations and networking, senior pharma/biotech executives and solution providers participate in pre-scheduled mutually selected one-on-one business meetings.

In order to create a balance of service offerings for qualified delegates and increased value, we limit service category competition at each summit. However, we are always interested in exploring new solutions and service categories.

If you would like your organization to be considered, please contact David Drey at d.drey@marcusevansch.com.

http://www.evolutionsummit.com

May 13-15, 2014

Oversight of Clinical Monitoring: Trends and Strategies

Course Level: Intermediate

Three-Part Online Training Course

Hear from experienced faculty on the trends impacting monitors, requirements, approaches, selection, and how to manage a site monitor’s performance. This intermediate course also focuses on the elements of risk-based monitoring.

Featured Topics:

  • Trends in the clinical development landscape driving change
  • ICH and FDA requirements for site monitoring
  • Current approaches to risk-based monitoring
  • Warning signs and problems with site monitors
  • Managing site monitors and their performance
  • Common errors made in site monitoring
  • Metrics used to measure site monitor performance

Overview

Register Online

June

June 3, 2014

Online Training Course, Preparing for a Clinical Trial Budget

Course Level: Intermediate

Online

This hands-on course will teach you how to prepare a high-level estimate of a clinical trial budget. You will walk through practical examples of estimating a clinical trial budget and the assumptions associated with each.

Featured Topics:

  • Identify cost triggers in a clinical trial
  • Estimate investigator fees
  • Estimate CRO costs
  • Estimate consulting fees
  • Budgeting Tips and Tricks

Faculty: Cris M. Howard, MBA, MEd, PMP Project Director, Global Project Management, Covance

Overview

Register Online

June 11-12, 2014

Pediatric Clinical Trials Conference

Philadelphia, Pennsylvania

The 10th Pediatric Clinical Trials Conference will provide executives with successful tools and best practices to effectively submit a PIP that meets FDA and EMA regulations, leverage clinical pharmacology data into data used in a pediatric clinical trial design, utilize unique recruitment tactics to improve participation and retention in clinical trials, and expedite drug development for the pediatric population.

Key Topics

  • Ensure compliance with FDA & EMA when submitting a Pediatric Investigation Plan (PIP)
  • Utilize clinical pharmacology as a benchmarking tool to model adult data to pediatrics
  • Develop Pediatric Study Plans (PSPs) for specific therapeutic areas
  • Use the Patient Reported Outcomes (PRO) to determine quality of life measures while ensuring patient safety
  • Create a Pediatric Center of Excellence to demonstrate the significance of the pediatric portfolio to the organization’s bottom line

Contact michellet@marcusevnasch.com for more information or to receive the conference brochure. Call 312-540-3000 ext 6491 to book your seat today.

http://bit.ly/ODJvZm

June 15-19, 2014

DIA 2014 50th Annual Meeting: Celebrate to the Past- Invent the Future

San Diego Convention Center
San Diego, California

Network, Converse, and Hear from Key Though Leaders in Clinical Research!

This year marks the 50th Anniversary of the DIA Annual Meeting, the largest multidisciplinary event that brings together a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

260+ educational offerings over 21 tracks on today’s hottest topics, including:

  • Patient Engagement
  • Patient Registries
  • Observational Studies
  • Partnership Strategies
  • Patient Recruitment Strategies
  • Protocol Design
  • Risk-based Monitoring
  • Plus Much More

Search Hot Topic Tracks in this year’s program!

Overview

View Preliminary Program

Register Online

August

August 12-13, 2014

3rd Annual Clinical Trials Inspection Readiness Summit

Philadelphia, Pennsylvania

ExL Pharma’s 3rd Annual Clinical Trials Inspection Readiness Summit taking place August 12-13th in Philadelphia, PA, is designed to evaluate the necessary steps that sponsoring companies must take in order to ensure that their clinical investigator sites remain compliant before and during an agency inspection, to avoid serious fines and penalties. The conference will also explore the importance of conducting internal audits and opening up the lines of communication between the investigators and the sponsoring company, both locally and globally.

Attendees will take a deep-dive into the regulatory criteria for remaining compliant for a clinical inspection, learn proactive strategies designed to prepare investigators for an inspection throughout an entire clinical trial, as well as learn how to prepare for a clinical inspection. Interested in attending? Register here and enjoy 15% off as part of our early bird rate!

August 18-19, 2014

New Drug Product Development and Life Cycle Management

Course Level: Beginner

Boston, Massachusetts

This course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and minimize the risks associated with shepherding a new drug candidate through the development process.

At the end of this course, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.

Faculty: Courtland R. LaVallee, Director, Project Management, Theravance, Inc.

Overview

Register Online

August 18-19, 2014

Clinical Project Management

Course Level: Intermediate

Boston, Massachusetts

The practical hands-on activities in this course will help you create a custom operations plan for clinical trials. The course covers clinical project management from the planning stage through development, execution, and project close-down.

Faculty: Cris M. Howard, MBA, MEd, PMP Project Director, Global Project Management, Covance

Overview

Register Online

September

September 9-10, 2014

2014 Pharma CI Conference & Exhibition

Hilton Parsippany Hotel
Parsippany, New Jersey
http://pharmaciconference.com

The Pharma CI Conference & Exhibition (September 9-10, 2014, Parsippany, NJ) is THE INDUSTRY'S GOLD STANDARD for senior level pharmaceutical, biotechnology, medical device, and diagnostics professionals seeking the latest news and the rare chance to network with all the industry's luminaries. This is the biggest and best gathering of pharmaceutical competitive intelligence thought leaders (75+ speakers)!

Join us at this premier gathering and network with other key decision makers as you learn about the most pressing and relevant issues facing the industry today. Enjoy the highest ratio of industry practitioners (pharma, biotech, medical device and diagnostics) of any pharma intelligence conference!

This is the only event featuring a world-class line up of speakers and panelists offering their unique insights and expertise on the topics you care about most! For more information, please go to http://pharmaciconference.com, call 212-228.7974, or email info@pharmaciconference.com

September 10, 2014

Global Clinical Trials

The Fairmont Copley Plaza
Boston, Massachusetts

The 2014 program is being offered as a one-day intensive followed by the option to attend the Disruptive Innovations to Advance Clinical Trials conference.

The conference covers solutions to the current barriers and challenges in planning and executing successful global clinical trials and in particular, how to reduce the complexities of them. Example topics covered include, but are not limited to:
1. Lessons Learned from Unsuccessful Global Clinical Trials
2. Regulatory Update on Global Clinical Trials and in particular Emerging Markets
3. How Companies are Re-Thinking Global Clinical Trials
4. Partnering with Global Investigative Sites
5. CRO Best Practices in Collaborations, Implementation and Execution of Multi-National Trials
6. Risk Based Monitoring for Global Clinical Trials
7. Technologies Driving Efficiencies in Global Clinical Trials
8. Designing Patient-Centric Protocols to Increase Global Patient Engagement
9. Reducing Protocol Complexity
10. Re-Thinking Global Patient Recruitment and the Patient Experience in Global Clinical Trials
11. Audit Inspections Update
12. Trends of Approvals Outside the US

Take a look at the 2013 agenda to get a good idea of the flow of the program. This conference is offered as a one-day event or can be combined with the Disruptive Innovations to Advance Clinical Trials conference on September 11-12 in the same venue. The conference includes breakfast, networking breaks, and a luncheon. For any questions, contact us at Service@theconferenceforum.org

Learn more: http://theconferenceforum.org/conferences/executing-global-clinical-trials/overview/

September 11-12, 2014

Disruptive Innovations

The Fairmont Copley Plaza
Boston, Massachusetts

The Conference Forum’s Dpharm: Disruptive Innovations to Advance Clinical Trials event is now in its 4th year and is the only program truly dedicated to the development of a program that demonstrates disruption in clinical trials. The conference brings together an exceptional audience of out-of-the-box thinkers determined to make clinical trials more affordable, efficient with higher quality data and a far better experience for patients. It is an outcomes-focused program that not only delves deeply into the key strategic factors impeding clinical trial productivity, but also endeavors to connect change makers who can share current solutions, propose new solutions and commit to testing them and share the results. This conference is designed to be engaging in a highly informative format, similar to the style of TED events. Each session will deliver a clear set of objectives, summary and key take-aways.

Focus & Objectives

  • This is a TED-style event showcasing innovations and leading practitioners in Pharma R&D with a focus on clinical research as well as innovative leaders from other industries.
  • We strive to underscore the promise and challenge of innovation in advancing drug development.
  • We strive to innovate a new model and find collaborations to get therapeutics to patients faster.
  • We address how can we better apply the full spectrum of clinical research options and utilize insights more appropriately.
  • We are dedicated to designing creative solutions and finding a way to implement them.
  • We explore to whom are companies being disruptive to and gain a better understanding of the impact on clinical trials.

We invite you to explore the 2013 agenda, visit our newsletter and let us know if you have any questions or ideas to share. Contact us at service@theconferenceforum.org

http://theconferenceforum.org/conferences/disruptive-innovations/overview/

September 15, 2014

Development of a Clinical Study Report

Course Level: Beginner

Washington, DC

This fast-track course is designed for professionals new to clinical development and Clinical Study Report preparation. The Clinical Study Reports for submission to the Health Authorities are required to be in compliance with the International Conference on Harmonization (ICH) standards and must meet high quality standards so that it provides most concise yet comprehensive summary of the study. The course will provide you with the latest strategies for preparing such clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.

Faculty: Patricia A. Matone, PhD, President, Scientific Information Services LLC

Overview

Register Online

September 21-23, 2014

Clinical Trials Innovation Exchange

The Clinical Trials and Innovation Exchange is a part of a series of events focused on the pharmaceutical industry that will serve as the hub for clinical trial executives to meet, share ideas, benchmark and discuss solutions to real world problems. It will offer cutting-edge, interactive learning opportunities for pre-qualified practitioners to gain actionable insights and continue to improve the clinical trial process.

This exchange is designed for senior clinical and research executives who are responsible for leading the execution of sound clinical trials within the established costs, quality and time constraints. They are also responsible for driving operational excellence and building collaborative relationships with all stakeholders involved.

Being at the forefront of drug development and being innovative during the process are important issues that are on clinical trial executives’ minds. Executives working within clinical trials have the opportunity to improve ways to productively produce studies that will be successful and meet important milestones. As clinical trials continue to be an essential part of developing medical treatments, executives in this field are pressed to find innovative solutions to recruit patients, meet regulations and use the appropriate technology to complete trials in a timely manner and avoid exceeding the designated budget.

This is accomplished, in part, by:

  • Developing patent engagement and partnerships
  • Understanding and capitalizing on new technologies and solutions
  • Being at the forefront of an industry and discovering innovative ways of conducting trials

Clinical Trials & Innovation Exchange presents the opportunity for delegates to network and build partnerships with peer level professionals, while learning new ideas and strategies that they can replicate within their own organizations, to build a best practices culture. Clinical Trials & Innovation Exchange has the following distinguishing features:

  • BrainWeave® discussions
  • Exclusive senior level attendance
  • Strategic conference sessions
  • Customized itinerary
  • One-on-one business meetings

Learn more: http://www.clinicaltrials-exchange.com/

September 25-26, 2014

11th Latin American Conference of Clinical Research (LACCR)

Monterrey City, NL, Mexico

DIA’s 11th LACCR is the top regional academic forum on clinical research in Latin America. LACCR is the only neutral forum in the region aimed at fostering the integration of professionals in the field, aiming to fully develop Latin America’s potential in the scope of clinical research globally. The two-day conference will feature presentations on hot topics ranging from global issues to focusing on specific details of clinical research and medical devices. Speakers will highlight the most relevant issues for the Latin American region in regulatory, pharmacoeconomy, ethics, a clinical site’s infrastructure, the components of clinical research, and much more.

Overview