Clinical Safety & Pharmacovigilance
Global Pharmacovigilance Strategies from the Experts Who Know Them
Features and Benefits
- Our world-class faculty address the practical and theoretical aspects of the conduct of pharmacovigilance, with emphasis on understanding of the concepts, themes underlying effective processes, and the basic tenets of global regulatory compliance with safety principles
- DIA is an established, recognized authority in the pharmaceutical industry and has been for more than 48 years
- As an independent, not-for-profit, global association of members with no corporate sponsors, DIA offers an objective program that results in a DIA Certificate of Completion
- Many courses offer Continuing Education Credits
What You Will Learn
- Pre- and postmarketing clinical safety and pharmacovigilance
- Risk management strategies
- How to prepare for a safety inspection
- Medical approach in diagnosis and management of ADRs
- Signal detection and data mining
- Drug safety surveillance and epidemiology
* In order to complete the required Core CSPCP units and avoid an overlap in curriculum content, it is suggested that program participants register for the Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum course.
Certificate Program Requirements
Core (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Core Units)
Core details HideView
Electives (Must successfully complete 16 Clinical Safety & Pharmacovigilance Certificate Program (CSPCP) Elective Units)
Electives details HideView
| Course Name | CE Hours | Program Units |
Benefit Risk Webinar Series
-
Location: | None Available | 1.00 |
Assessing the Benefits and Risks of Medicines: Webinar Series Part 2-Benefit-Risk Assessment: A Changing Regulatory Landscape
-
Location: | None Available | 1.00 |
Drug & Cosmetic Rule Amendments: Changes in Regulations Governing Clinical Trials in India
06/06/2013- 06/06/2013
Location: Online | IACET 1.50 | 1.00 |
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis
06/12/2013- 06/12/2013
Location: Online | ACPE 1.50, IACET 1.50 | 1.00 |
DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science
06/23/2013- 06/27/2013
Location: Boston, MA, United States | ACPE 18.00, CME 18.00, IACET 24.00, PMI 12.00, RN 18.00 | 4.00 |
#30: Analysis of Safety Data from Clinical Trials
06/23/2013- 06/23/2013
Location: Boston, MA, United States | ACPE 3.25, CME 3.25, IACET 3.25 | 2.00 |
#31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned
06/23/2013- 06/23/2013
Location: Boston, MA, United States | CME 3.25, IACET 3.25 | 2.00 |
#56: Risk Communications
06/23/2013- 06/23/2013
Location: Boston, MA, United States | ACPE 6.50, CME 6.50, IACET 6.50, RN 6.50 | 4.00 |
New Good Pharmacovigilance Practice (GVP) documents in Canada
07/17/2013- 07/17/2013
Location: Online | IACET 1.50 | 1.00 |
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 8: Visualization and Communication of Benefit-Risk
07/24/2013- 07/24/2013
Location: Online | ACPE 1.50, IACET 1.50 | 1.00 |
Adverse Event Reporting Requirements: IND and Postmarketing
07/30/2013- 08/01/2013
Location: Online | IACET 4.50 | 3.00 |
Risk Management and Safety Communications Strategies
11/04/2013- 11/05/2013
Location: Horsham, PA, United States | ACPE 13.25, IACET 13.25 | 8.00 |