Advertisement
DIA
Drug Information Association Logo

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.

Downloads

Certificate Program Requirements

Core (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Core Units)
Electives (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Elective Units)
Course NameCE HoursProgram Units
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- 06/05/2015
Location: Online
None Available3.00
Pharmacovigilance and Risk Management: Patient Perspective
05/22/2014- 05/21/2015
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- 06/30/2015
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- 02/01/2016
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
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
11/13/2014- 12/08/2015
Location: Online
None Available1.00
Implementation and Status of Periodic Benefit-Risk Evaluation Reporting (PBRER) in Canada
11/05/2014- 12/08/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3 Part Webinar Series - Part 3: Understanding the Legislation Landscape: Regulatory Updates from the FDA, EMA and Health Canada
02/11/2015- 02/01/2016
Location: Online
None Available1.00
GVP Module IX Compliant Signal Management Systems in Pharmacovigilance: A Tale of Two Experiences
04/02/2015- 04/02/2015
Location: Online
ACPE 1.50, IACET 1.501.00
GVP Module IX Compliant Signal Management Systems in Pharmacovigilance: A Tale of Two Experiences
04/03/2015- 04/01/2016
Location: Online
None Available1.00
DIA/FDA Statistics 2015 Forum
04/20/2015- 04/22/2015
Location: North Bethesda, MD, United States
IACET 18.504.00
How to Prepare for a Safety Inspection
06/01/2015- 06/03/2015
Location: Online
IACET 6.004.00
DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.
-
Location:
CME 18.00, RN 18.004.00
#25: Signal Detection: Identifying and Managing Safety Signals
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#40: Analysis of Safety Data from Clinical Trials
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#44: Risk Management and Safety Communication Strategies
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#45: The Good Pharmacovigiliance Practices in the EU: Global Applications
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 6.50, IACET 6.50, RN 6.504.00
Introduction to Signal Detection and Data Mining
10/05/2015- 10/08/2015
Location: Online
IACET 6.004.00
Risk Management and Safety Communication
10/26/2015- 10/27/2015
Location: Washington, DC, United States
ACPE 13.00, IACET 13.008.00