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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

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
CDER Town Meeting: Safety Hot Topics
01/29/2014- 07/28/2014
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/24/2015
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/24/2015
Location: Online
None Available1.00
Strategies for Successfully Introducing REMS to Your Organization: From Development and Implementation to Internal and External Evaluation
04/23/2014- 04/23/2014
Location: Online
IACET 1.501.00
Good Pharmacovigilance Practice: How Good has it Proven to be for Industry?
04/29/2014- 04/29/2014
Location: Online
IACET 1.501.00
How to Prepare for a Safety Inspection
05/06/2014- 05/08/2014
Location: Online
IACET 6.003.00
Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline
05/07/2014- 05/09/2014
Location: North Bethesda, MD, United States
ACPE 16.50, CME 16.50, IACET 16.504.00
DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"
-
Location:
ACPE 18.00, CME 18.00, IACET 24.00, PMI 15.00, RN 18.004.00
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#40: Analysis of Safety Data from Clinical Trials
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#44: Quality by Design: From Theory to Practice
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 6.50, IACET 6.50, RN 6.504.00
#45: Risk Management Plan
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#46: The Good Pharmacovigilance Practices In The EU: Lessons Learned and Frequently Asked Implementation Questions
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 6.50, IACET 6.50, RN 6.504.00
Adverse Event Reporting Requirements: IND and Postmarketing
07/22/2014- 07/24/2014
Location: Online
IACET 4.503.00
Introduction to Signal Detection and Data Mining
09/29/2014- 10/02/2014
Location: Online
IACET 6.004.00
Risk Management and Safety Communication Strategies
11/10/2014- 11/11/2014
Location: Bethesda, MD, United States
ACPE 13.25, IACET 13.258.00