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Basic Pharmacovigilance and Pharmacovigilance Regulations

Basic Pharmacovigilance and Pharmacovigilance Regulations

  •  Degree
  •  75h
  •  Introductory
US/EU Regulations: principles and comparison

US/EU Regulations: principles and comparison

  •  Award
  •  180min
Overview of the Legal Basis of PV Regulations and the Role of the QPPV

Overview of the Legal Basis of PV Regulations and the Role of the QPPV

  •  Award
  •  180min
Principles of Labeling and Description of United States Prescribing Information (USPI)

Principles of Labeling and Description of United States Prescribing Information (USPI)

  •  Award
  •  180min
Pharmacovigilance in Combination Products and Regulations

Pharmacovigilance in Combination Products and Regulations

  •  Award
  •  180min
From individual cases to the community impact of adverse drug reactions: measuring tools

From individual cases to the community impact of adverse drug reactions: measuring tools

  •  Award
  •  120min
Aggregate reporting in the US

Aggregate reporting in the US

  •  Award
  •  150min
Pharmacovigilance for Biologics

Pharmacovigilance for Biologics

  •  Degree
  •  75h
  •  Intermediate
Vaccines Biologics Regulations

Vaccines Biologics Regulations

  •  Award
  •  180min
Gene therapy

Gene therapy

  •  Award
  •  180min
Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)

Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)

  •  Award
  •  180min
Targeted Therapeutics

Targeted Therapeutics

  •  Award
  •  180min
External databases/RWD/RWE

External databases/RWD/RWE

  •  Degree
  •  75h
  •  Intermediate
FDA Adverse Event Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS)

  •  Award
  •  150min
FDA Sentinel System

FDA Sentinel System

  •  Award
  •  150min
Health care records from large databases as a tool to study the use of medicines

Health care records from large databases as a tool to study the use of medicines

  •  Award
  •  120min
Integrating Pharmacovigilance and consumption data analysis - uses, limitations and potentiality

Integrating Pharmacovigilance and consumption data analysis - uses, limitations and potentiality

  •  Award
  •  120min
Benefit Risk Assessment

Benefit Risk Assessment

  •  Degree
  •  75h
  •  Intermediate
Principles and methods of benefit-risk assessment in decision-making of medicines

Principles and methods of benefit-risk assessment in decision-making of medicines

  •  Award
  •  120min
Role of benefit-risk assessment and pharmaco-economics in decision-making of medicines

Role of benefit-risk assessment and pharmaco-economics in decision-making of medicines

  •  Award
  •  150min
Concepts in Risk Management

Concepts in Risk Management

  •  Award
  •  180min
Organization for risk management in the industry

Organization for risk management in the industry

  •  Award
  •  180min
Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS)

  •  Award
  •  135min