Pharmacovigilance 4 - Signalling and Risk Assessment

Module 4 of 4 - Pv Signalling & Risk Assessment Course

The Pharmacovigilance Signalling & Risk Assessment course is recommended if you are involved in drug safety, clinical trials, pharmacoepidemiology and risk management. The Pharmacovigilance Signalling & Risk Assessment course covers key components of signal detection, including; definitions, objectives, examples, FDA risk management constituents, EU Signalling requirements and data mining principles. Each of these factors are crucial for a company to ensure that they match legislation – one of signalling and risk management’s primary objectives is to understand and manage the risk profiles of drugs to help avoid hugely expensive and damaging drug withdrawals. Pharmacovigilance Signalling & Risk Assessment is a great addition to your knowledge in pharmacovigilance when combined with The Pharmacovigilance Audit course.

Average study time:

3 hrs
Personal development points (CPD):

3 points
Price:

£79.00

View demo

Course Details

This course comprehensively explains signalling and risk assessment in Pharmacovigilance, including an overview of data mining, signal detection and its requirements across European and American markets. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

CPD Points - Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification - Receive a personal certificate to show your subject knowledge on course completion.
Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date - You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts - The course content has been developed to ensure that you comply with pharmacovigilance legislation through the application of learning outcomes. The course is written by Steve Jolley, who is a chairperson for the Drug Information Association (DIA)

Course Syllabus

1. Learning Objectives for this Module

2. Background to Signal Detection

Need for Signal Detection

Increased Withdrawals (1998-2001)

3. Reason for Change

Rezulin Withdrawal

Baycol Withdrawal

The Cost of Failure

4. Legalities

FDA Risk Management Components

FDA Amendment Act (FDAAA)

EMA Signalling Requirement

MHRA & Signal Detection

GVP Module IX

5. Signal Detection Objectives & Key Components

AE Incidence Rate

Numerator (AEs)

Denominator (Patient Exposure)

Rates

Premise

CIOMS VIII reference to the “Prepared Mind”

Signal detection hierarchy

6. Signalling Analyses

Approach to Signal Detection – Small Companies

Approach to Signal Detection – Large Companies

Data extraction and visualization

Data flow

PSUR prior to analysis

Sector map by SOC

Sector Map by PT

Analysis by Preferred Term

Analysis by Age Range

Analysis by Sex

Analysis by Country

Analysis by concomitant medications

7. Data Mining Examples

What is Data Mining?

Principles of Safety Data Mining

Recommended approach – Large Companies

8. Data Mining Methods

Data Mining Methods

Information Component (IC)

Bayesian Confidence Propagation Neural Network (BCPNN)

PSUR Data

IC Scores - PSUR

Multi-item Gamma Poisson Shrinker (MGPS)

Proportional Reporting Ratio (PRR)

PRR Example