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Clinical Project Management: Advanced Concepts in Project Management

Course #: SMYA1118
November 27-28, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene Cira Centre
$1,687.50

Advanced Good Clinical Practice: Practical Application and Implementation

EARLY REGISTRATION
Course #: SADB1218
December 3-4, 2018 | Boston, MA
8:30 AM - 5:00 PM Eastern
Metro Meeting Centers - Boston
Take advantage of our $1507.50 price by registering early!
* After Thursday, November 22, 2018, costs are $1687.50.
$1,507.50

CRA & CRC: Beginner Program

Course #: SCOA1218
December 3-5, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene CityView
$1,795.50

Comprehensive Monitoring for Medical Devices

Course #: SDOD1218
December 4-6, 2018 | San Diego, CA
8:30 AM - 5:00 PM Eastern
San Diego Solamar
$1,795.50

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

Course #: SSVB1218
December 4-5, 2018 | Boston, MA
8:30 AM - 5:00 PM Eastern
Convene at One Boston Place
$1,687.50

Adverse Events: Managing and Reporting for Medical Devices

Course #: SDAB1218
December 11-12, 2018 | Boston, MA
8:30 AM - 5:00 PM Eastern
Convene at One Boston Place
$1,687.50

Clinical Project Management: Fundamentals of Project Management

Course #: SPMA1218
December 11-12, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene Cira Centre
$1,687.50

Effectively Writing Clinical Trial Protocols

Course #: STPF1218
December 11-12, 2018 | San Francisco, CA
8:30 AM - 5:00 PM Eastern
Hilton San Francisco Union Square
$1,687.50

Monitoring Clinical Drug Studies: Beginner

Course #: SSBB1218
December 11-13, 2018 | Boston, MA
8:30 AM - 5:00 PM Eastern
Convene at One Boston Place
$1,795.50

Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions

Course #: SPDF1218
December 11-12, 2018 | San Francisco, CA
8:30 AM - 5:00 PM Eastern
Hilton San Francisco Union Square
$1,687.50

Working with CROs: Building a Partnership for Project Success

Course #: SPSA1218
December 11-12, 2018 | Philadelphia, PA
8:30 AM - 5:00 PM Eastern
Convene CityView
$1,687.50

Advanced Post-Marketing Pharmacovigilance Auditing

Course #: SPPF1218
December 11-12, 2018 | San Francisco, CA
8:30 AM - 5:00 PM Eastern
Hilton San Francisco Union Square
$1,687.50

Monitoring Clinical Drug Studies: Intermediate

EARLY REGISTRATION
Course #: SSIB1218
December 18-19, 2018 | Boston, MA
8:30 AM - 5:00 PM Eastern
Convene at One Boston Place
Take advantage of our $1507.50 price by registering early!
* After Friday, November 16, 2018, costs are $1687.50.
$1,507.50

Adverse Event Monitoring for CRAs

Course #: BI13389
January 16, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Auditing Techniques for Clinical Research Professionals

EARLY REGISTRATION
Course #: SFCB0119
January 17-18, 2019 | Boston, MA
8:30 AM - 5:00 PM Eastern
Convene at One Boston Place
Take advantage of our $1507.50 price by registering early!
* After Sunday, December 16, 2018, costs are $1687.50.
$1,507.50

Monitoring Oncology Clinical Trials

Course #: BI13390
January 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Monitoring Clinical Drug Studies: Advanced

EARLY REGISTRATION
Course #: SSAD0119
January 23-24, 2019 | San Diego, CA
8:30 AM - 5:00 PM Eastern
San Diego Solamar
Take advantage of our $1507.50 price by registering early!
* After Friday, December 21, 2018, costs are $1687.50.
$1,507.50

Conducting Clinical Trials Under ICH GCP E6

EARLY REGISTRATION
Course #: SGCD0119
January 24-25, 2019 | San Diego, CA
8:30 AM - 5:00 PM Eastern
San Diego Solamar
Take advantage of our $1507.50 price by registering early!
* After Friday, December 21, 2018, costs are $1687.50.
$1,507.50

NEW! Clinical Research Financial Management for Investigative Sites

Course #: BI13556
February 4, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites

Course #: BI13391
February 5, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$751.50

10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series

EARLY REGISTRATION
Course #: BI13375
February 5 - April 8, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Tuesday Afternoons.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 4, 2019, costs are $1795.50.
$1,615.50

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program

EARLY REGISTRATION
Course #: BI13378
February 7 - April 11, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Thursday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 4, 2019, costs are $1795.50.
$1,615.50

Cases in Advanced GCP: A Problem-Solving Practicum

Course #: BI13392
February 7, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

ABCs of Clinical Research for Clinical Administrative Support Staff

Course #: Bi13393
February 11, 2019 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

ABCs of GCP and the 13 Principles of ICH GCP E6

Course #: BI13394
February 11, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Establishing Quality Tolerance Limits

Course #: BI13545
February 12, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Source Documentation: What is Adequate and Accurate?

Course #: BI13395
February 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank

Course #: BI13396
February 19, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning

Course #: BI13397
February 19, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Course #: BI13398
February 19, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

Good Clinical Practice: Practical Application and Implementation

Course #: BI13399
February 20, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Use of Electronic Health Record Data in Clinical Investigations

Course #: BI13400
February 20, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

Use of Notes to File in Clinical Trial Essential Documentation

Course #: BI13401
February 21, 2019 | Interactive Web Seminar
8:30 AM - 10:00 AM Eastern
$751.50

Investigator Initiated Trials: Roles and Responsibilities

Course #: BI13402
February 21, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$661.50

Monitoring Plan Development

Course #: BI13403
February 21, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$661.50

30-Hour Clinical Research Auditing Certification Program

EARLY REGISTRATION
Course #: BI13384
February 21 - April 25, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Thursday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 18, 2019, costs are $1795.50.
$1,615.50

NEW! Auditing Techniques: A Problem-Solving Practicum

Course #: BI13550
February 22, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

NEW! 10-Week Clinical Research Financial Certification Program: Setting Up Compliant Financial Operations and Budgets

EARLY REGISTRATION
Course #: BI13387
February 25, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Monday Afternoons. No class April 15.


Take advantage of our $1615.50 price by registering early!
* After Friday, January 25, 2019, costs are $1795.50.
$1,615.50

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

Course #: BI13404
February 28, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

EARLY REGISTRATION
Course #: BI13372
March 1 - May 10, 2019 | Interactive Web Seminar
9:30 AM - 12:30 PM Eastern

Friday Mornings. No class April 12.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 1, 2019, costs are $1795.50.
$1,615.50

10-Week Clinical Research Associate (CRA) On-Boarding Program

EARLY REGISTRATION
Course #: BI13371
March 1 - May 10, 2019 | Interactive Web Seminar
1:00 PM - 4:00 PM Eastern

Friday Afternoons. No class April 12.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 1, 2019, costs are $1795.50.
$1,615.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

Course #: BI13405
March 5, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research

EARLY REGISTRATION
Course #: BI13376
March 5 - May 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern

Tuesday Mornings. No class April 2.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 1, 2019, costs are $1795.50.
$1,615.50

Approaches to Address Challenges in Vendor Management

Course #: BI13406
March 5, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

Introduction to Statistics for Non-Statisticians

Course #: BI13407
March 5, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

CRO Partnership Management

Course #: BI13408
March 6, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Tools for Trainers: Clinical Research Job-Aids and Checklists

Course #: BI13409
March 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Developing Clinical Study Budgets for Sponsors

Course #: BI13410
March 12, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Writing Clinical Study Protocols

Course #: BI13411
March 13, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

Course #: BI13412
March 14, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

TMF/eTMF Audit Strategies

Course #: BI13413
March 15, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance

Course #: BI13414
March 15, 2019 | Interactive Web Seminar
11:30 AM - 1:30 PM Eastern
$751.50

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

Course #: BI13415
March 18, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Monitoring Reports: 10 Rules of Effective Report Writing

Course #: BI13416
March 18, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Strategies for Managing Difficult Clinical Research Sites

Course #: BI13417
March 19, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$751.50

NEW! Coaching Skills for Leaders

Course #: BI13418
March 19, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Principal Investigator Oversight and the Appropriate Delegation of Tasks

Course #: BI13419
March 19, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern
$661.50

Building Relationships with Clinical Research Sites

Course #: BI13420
March 20, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Advanced Clinical Research Coordinator Training: Moving Your Career to the Next Level

Course #: BI13421
March 20, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for Industry

Course #: BI13551
March 20, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern
$661.50

Electronic Informed Consent Guidance: Regulatory Updates

Course #: BI13422
March 21, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Subject Recruitment: Proactive Project Plans and Issues Management

Course #: BI13423
March 21, 2019 | Interactive Web Seminar
12:00 PM - 2:00 PM Eastern
$562.50

Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance

Course #: BI13424
March 21, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

30-Hour Clinical Research Auditing Certification Program

EARLY REGISTRATION
Course #: BI13386
March 22 - June 7, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Thursday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 29, 2019, costs are $1795.50.
$1,615.50

30-Hour Clinical Project Management Fundamentals Certification Program

EARLY REGISTRATION
Course #: BI13383
March 22 - May 31, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern

Friday Afternoons. No class April 12.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

NEW! Strategies for Having Difficult Conversations

Course #: BI13425
March 26, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

30-Hour Clinical Data Management On-Boarding Program

EARLY REGISTRATION
Course #: BI13380
March 27 - May 29, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern

Wednesday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

Writing the Clinical Study Report

Course #: BI13426
March 27, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

Final ICH GCP E6 R2: Impact on Clinical Data Management

Course #: BI13427
March 27, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Week CRA & CRC Beginner Program

EARLY REGISTRATION
Course #: BI13368
March 27 - May 29, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Wednesday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, February 22, 2019, costs are $1795.50.
$1,615.50

Risk-Based Site Monitoring

Course #: BI13428
March 28, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

The Revised HHS Common Rule: What You Need to Know Now

Course #: BI13543
March 28, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)

Course #: BI13429
April 2, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

NEW! Strategies for Active Listening

Course #: BI13430
April 2, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites

Course #: BI13431
April 3, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

Course #: BI13433
April 4, 2019 | Interactive Web Seminar
11:00 AM - 12:30 PM Eastern
$661.50

Ensuring Success Through Smarter Site Selection and Study Feasibility

Course #: BI13432
April 4, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

eTMF Quality Oversight: A Risk-Based Approach

Course #: BI13434
April 5, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

Course #: BI13435
April 8, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

Course #: BI13436
April 8, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Introduction to Clinical Research

Course #: BI13438
April 9, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Investigator Initiated Trials: Roles and Responsibilities

Course #: BI13437
April 9, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

Informed Consent Procedure: Lessons Learned from Inspection Findings

Course #: BI13440
April 9, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

10-Week Clinical Research Associate (CRA) On-Boarding Program

EARLY REGISTRATION
Course #: BI13539
April 9 - June 11, 2019 | Interactive Web Seminar
6:00 PM - 9:00 PM Eastern

Tuesday Evenings.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 8, 2019, costs are $1795.50.
$1,615.50

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Course #: BI13443
April 10, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Medical Writing Fundamentals: How to Write Regulatory Documents

Course #: BI13444
April 10, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$661.50

ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank

Course #: BI13442
April 10, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

Introduction to Data Management

Course #: BI13441
April 10, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Use of Electronic Health Record Data in Clinical Investigations

Course #: BI13445
April 11, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

Good Clinical Practice: Practical Application and Implementation

Course #: BI13446
April 11, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$751.50

10-Week Risk Management/Risk-Based Quality Management for Clinical Trials Certification Program

EARLY REGISTRATION
Course #: BI13379
April 11 - June 13, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

Thursday Afternoons.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 8, 2019, costs are $1795.50.
$1,615.50

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

Course #: BI13447
April 12, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Data Quality in Clinical Trials: Rationale and Impact

Course #: BI13448
April 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Final FDA Guidance: How to Complete the Form FDA 1572, Adequately and Accurately

Course #: BI13449
April 17, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$562.50

Protocol Deviations: Documenting, Managing, and Reporting

Course #: BI13450
April 18, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$661.50

Monitoring Oncology Clinical Trials

Course #: BI13451
April 18, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance

Course #: BI13452
April 22, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

NEW! 10-Week Final ICH GCP E6 R2: Risk-Based Monitoring Plan Development Series

EARLY REGISTRATION
Course #: BI13374
April 23 - June 25, 2019 | Interactive Web Seminar
10:30 AM - 12:30 PM Eastern

Tuesday Mornings.


Take advantage of our $1615.50 price by registering early!
* After Friday, March 22, 2019, costs are $1795.50.
$1,615.50

Incorporating Denials Management into Clinical Research Billing

Course #: BI13453
April 23, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Case Report Form Design, Strategy, and Standards

Course #: BI13454
April 24, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50
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