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Clinical Safety & Pharmacovigilance

Global Pharmacovigilance Strategies from the Experts Who Know Them

Our expert faculty address the practical and theoretical aspects of pharmacovigilance, with emphasis on the concepts, effective processes, and safety principles of global regulatory compliance

This Certificate Program will provide the fundamental skills you need to do your job. Topics include, but are not limited to:

  • Premarketing clinical safety and pharmacovigilance
  • Postmarketing drug safety and pharmacovigilance
  • Risk management strategies
  • How to prepare for a safety inspection
  • Signal detection and data mining

Certificate Program Requirements

To successfully complete this Certificate Program, learners must complete 16 core units and 16 elective units; courses included in this program are noted below:

Course Title
Format
CSP Certificate
Program Units

Adverse Event Reporting Requirements: IND and Postmarketing
Online
3 Elective Units
How to Prepare for a Safety Inspection
Online
3 Elective Units
Introduction to Signal Detection and Data Mining
Online and Face-to-face
4 Elective Units
Postmarketing Drug Safety and Pharmacovigilance
Face-to-face
8 Core Units
Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
Face-to-face
16 Core Units
Premarketing Clinical Safety and Pharmacovigilance
Face-to-face
8 Core Units
Risk Management and Safety Communication Strategies
Face-to-face
8 Elective Units
* additional meetings and webinars are available to meet the elective unit requirements and will be noted in the upcoming schedule list below

* Completion of the Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum training course will meet the core requirements in lieu of taking both the Premarketing Clinical Safety and Pharmacovigilance and Postmarketing Drug Safety and Pharmacovigilance training courses.

Certificate Program Requirements

Electives (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Elective Units)
Course NameCE HoursProgram Units
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/28/2015
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/28/2015
Location: Online
None Available1.00
Introduction to Drug Safety
05/07/2014- 05/07/2017
Location: Online
ACPE 4.00, IACET 4.002.00
How to Prepare for a Safety Inspection
05/08/2014- 05/07/2015
Location: Online
None Available3.00
Pharmacovigilance and Risk Management: Patient Perspective
05/22/2014- 05/21/2015
Location: Online
None Available1.00
China Update: Regulatory Changes and Implications
05/28/2014- 11/27/2014
Location: Online
None Available1.00
Drug Safety Regulatory Requirements
04/15/2014- 04/21/2017
Location: Online
ACPE 4.00, IACET 4.002.00
Premarketing Clinical Trial Safety
04/15/2014- 04/21/2017
Location: Online
ACPE 4.00, IACET 4.002.00
Adverse Event Reporting Requirements: IND and Postmarketing
07/24/2014- 07/23/2015
Location: Online
None Available3.00
Pharmacovigilance and Global Harmonization Updates
07/24/2014- 07/23/2015
Location: Online
None Available1.00
Postmarketing Safety Management
04/15/2014- 04/21/2017
Location: Online
ACPE 3.00, IACET 3.002.00
Clinical Trials Transparency 3-Part Series: Moving the Debate Forward - Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 1 - Paving the Way for Greater Access To Data
09/09/2014- 11/11/2015
Location: Online
None Available1.00
Basics of Signal Detection and Pharmacoepidemiology
04/15/2014- 09/29/2017
Location: Online
ACPE 3.50, IACET 3.502.00
The Role of the Clinical Data Manager
10/08/2014- 10/07/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3-Part Series: Moving the Debate Forward-Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 2-Connecting the Research Community: Data Sharing–Perspectives from Academia and Patient Advocacy Groups
10/22/2014- 10/21/2015
Location: Online
None Available1.00
Safety Audits and Inspections
04/15/2014- 04/21/2017
Location: Online
ACPE 3.25, IACET 3.252.00
Implementing Risk-Based Monitoring: Practical Approaches
12/09/2014- 12/09/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Implementing Risk-Based Monitoring: Practical Approaches
11/13/2014- 12/09/2015
Location: Online
None Available1.00
Facets of Drug-Induced Kidney Injury and Regulatory Perspective
12/03/2014- 12/03/2014
Location: Online
ACPE 1.50, IACET 1.501.00
How to Prepare for a Safety Inspection
06/01/2015- 06/03/2015
Location: Online
IACET 6.004.00