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Clinical Investigator: Module 2 - Conducting The Study
|
Jun 20, 2013
|
ACPE, CME
|
Online Instruction
|
North America
|
Online
|
|
Clinical Investigator: Module 1 - Study Preparation and Initiation
|
Jun 20, 2013
|
ACPE, CME
|
Online Instruction
|
North America
|
Online
|
|
Informed Consent
|
Jun 20, 2013
|
ACPE
|
Online Instruction
|
North America
|
Online
|
|
Crisis Management
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Database Management
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Literature Evaluation
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Literature Searching
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Medical Inquiries
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Medical Writing
|
Jun 20, 2013
|
IACET
|
Online Instruction
|
North America
|
Online
|
|
Product Labeling
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Regulatory Issues
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Statistics for Medical Communications Professionals
|
Jun 20, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
A Tour of FDA
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
A Tour of Health Canada
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
A Tour of Health Europe
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Aspects of Regulatory History
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Bioresearch Monitoring Program (BIMO): Introduction
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Clinical Development Process: Investigational Product, Plan, and Data Management
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Drug Safety & Adverse Event Reporting
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Ethical Review Boards
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Ethics as the Foundation to Clinical Research
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Awareness of FDA Inspections for Pharmaceutical Manufacturers
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Biotechnology: An Overview of Compliance Considerations
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Change Control
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Clinical Trial Audits and Consequences of Non-Compliance
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Computerized Systems Inspections in the Medical Device Industry
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
European Union Clinical Trials Directive
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GMP Principals of SOPs
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GMP Updates - Enforcement Changes at the New FDA
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GMPs for API Bulk Manufacturers
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Good Clinical Practices (GCPs) for New Product Investigations
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Good Laboratory Practices (GLPs)
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GxPs
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
HIPAA - The Impact on Clinical Research
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to GMPs
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Investigational Product Development
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Key Concepts of Process Validation
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Laboratory Specimens for Clinical Research
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Medical Device Safety Reporting
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Orientation to GMP Compliance
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Overview of the Clinical Research Process
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Part 11: Electronic Records and Signatures - Application
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Part 11: Electronic Records; Electronic Signatures
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Principles of Good Documentation
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Protection of Human Subjects in Clinical Trials
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Selecting and Managing Clinical Contract Research Organizations (CROs)
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Understanding Post-Approval Changes
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Computerized Systems Inspections in the Pharmaceutical Industry
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of the PhRMA Code
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of AdvaMed Code
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Eucomed Guidelines on Interactions with Healthcare Professionals
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to Medical Device Health Care Compliance
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Foreign Corrupt Practices Act
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Global Anti-bribery
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Variations to Marketing Authorisation in Europe
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Registration of Monoclonal Antibodies
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Pharmacokinetics and Pharmacodynamics in Drug Registration
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to the European Union Institutions and Regulatory Authority
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to US Institutions and Regulatory Authority (FDA)
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to Japanese Institutions and Regulatory Authorities
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Overview of the CTD and eCTD
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to the International Conference on Harmonisation (ICH)
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Regulatory Development of a Drug
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of Pharmacovigilance
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of Clinical Trials
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register Medicinal Products through the Centralized Procedure
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register Medicinal Products through the Mutual Recognition Procedure
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Maintain Marketing Approvals in Europe for Centrally Authorised Products
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register a New Drug in the USA
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register Medicinal Products through the Decentralized Procedure
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Access to Unapproved Drugs through Compassionate Use
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Regulatory Requirements for the Conduct of Clinical Trials in Europe
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Orphan Drugs in the USA, European Union, and Japan
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Regulatory Requirements for the Submission of Investigational New Drug Applications in the USA (INDs)
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Meeting Opportunities with Regulatory Agencies
|
Jun 20, 2013
|
|
Online Instruction
|
Global
|
Online
|