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Implications of the FDA Guidance for a Risk?Based Approach to Monitoring and EMA Reflection Paper Risk Based Quality Management in Clinical Trials

Course #: BI13503
June 6, 2019 | Interactive Web Seminar
3:00 PM - 4:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Monitoring Reports: 10 Rules of Effective Report Writing

Course #: BI13504
June 7, 2019 | Interactive Web Seminar
8:30 AM - 11:30 AM Eastern
$751.50

NEW! Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials

Course #: BI13552
June 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

TMF/eTMF Audit Strategies

Course #: BI13505
June 7, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

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

Course #: BI13506
June 10, 2019 | Interactive Web Seminar
1:00 PM - 3:30 PM Eastern
$751.50

Introduction to Statistics for Non-Statisticians

Course #: BI13508
June 11, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Risk-Based Site Monitoring

Course #: BI13507
June 11, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Preparing Clinical Research Sites for FDA Inspections

Course #: BI13509
June 12, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$562.50

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

Course #: BI13510
June 12, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

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

Course #: BI13511
June 13, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50

eTMF Quality Oversight: A Risk-Based Approach

Course #: BI13512
June 14, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$751.50

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

Course #: BI13519
June 14, 2019 | Interactive Web Seminar
12:00 PM - 2:30 PM Eastern
$751.50
$751.50

NEW! Establishing Quality Tolerance Limits

Course #: BI13546
June 18, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

NEW! Implementing Quality Agreements

Course #: BI13547
June 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Strategies for Active Listening

Course #: BI13514
June 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

Course #: BI13515
June 18, 2019 | Interactive Web Seminar
2:00 PM - 3:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

Subject Recruitment: Proactive Project Plans and Issues Management

Course #: BI13516
June 19, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$562.50

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

Course #: BI13517
June 20, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Course #: BI13518
June 20, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Drug Development and FDA Regulations

Course #: BI13520
July 16, 2019 | Interactive Web Seminar
9:00 AM - 12:00 PM Eastern
$661.50

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance

Course #: BI13521
July 16, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern
$661.50

NEW! Coaching Skills for Leaders

Course #: BI13522
July 16, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Introduction to Data Management

Course #: BI13523
July 17, 2019 | Interactive Web Seminar
9:30 AM - 11:30 AM Eastern
$661.50

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

Course #: BI13553
July 17, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Writing Clinical Study Protocols

Course #: BI13524
July 17, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$751.50

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada

Course #: BI13525
July 17, 2019 | Interactive Web Seminar
12:30 PM - 2:30 PM Eastern

This web seminar qualifies for a reduced individual participant fee of $159. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$661.50

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

Course #: BI13527
July 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

NEW! Strategies for Having Difficult Conversations

Course #: BI13526
July 18, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50

Use of Notes to File in Clinical Trial Essential Documentation

Course #: BI13528
July 19, 2019 | Interactive Web Seminar
12:00 PM - 1:30 PM Eastern
$751.50

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

Course #: BI13529
July 23, 2019 | Interactive Web Seminar
9:00 AM - 11:00 AM Eastern
$751.50

NEW! Incorporating Denials Management into Clinical Research Billing

Course #: BI13530
July 23, 2019 | Interactive Web Seminar
1:00 PM - 3:00 PM Eastern
$751.50

Final ICH GCP E6 R2: Impact on Clinical Data Management

Course #: BI13531
July 24, 2019 | Interactive Web Seminar
9:30 AM - 11:00 AM Eastern
$661.50

Writing the Clinical Study Report

Course #: BI13532
July 24, 2019 | Interactive Web Seminar
12:00 PM - 3:00 PM Eastern
$661.50

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

Course #: BI13533
July 25, 2019 | Interactive Web Seminar
9:00 AM - 11:30 AM Eastern
$751.50

Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components

Course #: BI13534
July 29, 2019 | Interactive Web Seminar
8:30 AM - 11:00 AM Eastern

This web seminar qualifies for a reduced individual participant fee of $369. To register, call +1 781.972.5400 or toll-free in the U.S. 800-856-2556.

$751.50

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

Course #: BI13536
July 31, 2019 | Interactive Web Seminar
1:00 PM - 2:30 PM Eastern
$661.50