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Basic Pharmacovigilance and Pharmacovigilance Regulations

Basic Pharmacovigilance and Pharmacovigilance Regulations

  •  Degree
  •  3 ects
  •  Introductory
Pharmacovigilance for Biologics

Pharmacovigilance for Biologics

  •  Degree
  •  3 ects
  •  Intermediate
External databases - RWD - RWE

External databases - RWD - RWE

  •  Degree
  •  3 ects
  •  Intermediate
Benefit Risk Assessment

Benefit Risk Assessment

  •  Degree
  •  3 ects
  •  Intermediate
US-EU Regulations: principles and comparison

US-EU Regulations: principles and comparison

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

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

  •  Award
  •  180 min
Pharmacovigilance in Combination Products and Regulations

Pharmacovigilance in Combination Products and Regulations

  •  Award
  •  180 min
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
  •  120 min
Aggregate reporting in the US

Aggregate reporting in the US

  •  Award
  •  150 min
Vaccines Biologics Regulations

Vaccines Biologics Regulations

  •  Award
  •  180 min
Gene therapy

Gene therapy

  •  Award
  •  180 min
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
  •  180 min
Targeted Therapeutics

Targeted Therapeutics

  •  Award
  •  180 min
FDA Adverse Event Reporting System (FAERS)

FDA Adverse Event Reporting System (FAERS)

  •  Award
  •  150 min
FDA Sentinel System

FDA Sentinel System

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

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

  •  Award
  •  120 min
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
  •  120 min
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
  •  150 min
Concepts in Risk Management

Concepts in Risk Management

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

Organization for risk management in the industry

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

Risk Evaluation and Mitigation Strategy (REMS)

  •  Award
  •  135 min