LOG IN OR SIGN UP TO "MY Eu2P"AMERICAN PROGRAMME IN PHARMACOVIGILANCE
US-EU REGULATIONS: PRINCIPLES AND COMPARISON
Requirements for Pharmacovigilance in the United States as compared to the ones in the European Union, for Pre-approval and Post-approval
OVERVIEW OF THE LEGAL BASIS OF PV REGULATIONS AND THE ROLE OF THE QPPV
Legal framework that governs pharmacovigilance and the central role of the QPPV in pharmacovigilance practice
PRINCIPLES OF LABELING AND DESCRIPTION OF UNITED STATES PRESCRIBING INFORMATION (USPI)
Understand the principles of drug labeling, FDA regulations related to the label and description of USPI
PHARMACOVIGILANCE IN COMBINATION PRODUCTS AND REGULATIONS
Know the different types of combination products and safety monitoring strategy, identify applicable regulations and guidelines for safety management
FROM INDIVIDUAL CASES TO THE COMMUNITY IMPACT OF ADVERSE DRUG REACTIONS: MEASURING TOOLS
The importance of consumption data to estimate the potential impact of an ADR at a community level
AGGREGATE REPORTING IN THE US
Knowledge of aggregate reports, including PADERs, PAERs, as well as DSURs and PSURs as applicable to FDA requirements
VACCINES BIOLOGICS REGULATIONS
Overview of the different aspects of pharmacovigilance for vaccines and biologics
GENE THERAPY
Understand the view of the US regulators on Gene Therapy and EMA perspective of the advance therapies.
PHARMACOVIGILANCE FOR HUMAN CELLS, TISSUES AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT-PS)
Become familiar with different types of HCT/P products and select safety monitoring strategy based on streamline approach and primary mode of action
TARGETED THERAPEUTICS
Understand the current overall landscape of cancer therapy and adverse events related to targeted therapies
FDA ADVERSE EVENT REPORTING SYSTEM (FAERS)
Strengths and Limitations of the FAERS Database
FDA SENTINEL SYSTEM
Current FDA Sentinel Monitoring System and future FDA strategies to enhance it
HEALTH CARE RECORDS FROM LARGE DATABASES AS A TOOL TO STUDY THE USE OF MEDICINES
Data sources for information on medicines consumption. Critically assess some advantages and biases of these kind of studies
INTEGRATING PHARMACOVIGILANCE AND CONSUMPTION DATA ANALYSIS - USES, LIMITATIONS AND POTENTIALITY
Identify when an inappropriate use of medicines can be the cause of an unnecessary ADR. Plan analyses of medicines utilization data sources in order to identify preventable ADR.
PRINCIPLES AND METHODS OF BENEFIT-RISK ASSESSMENT IN DECISION-MAKING OF MEDICINES
Different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations
ROLE OF BENEFIT-RISK ASSESSMENT AND PHARMACO-ECONOMICS IN DECISION-MAKING OF MEDICINES
Insight in the changing health care environment and gives an overview of the different stakeholders that are involved in pharmacotherapeutic decision-making
CONCEPTS IN RISK MANAGEMENT
Overview and definition of the concepts necessary to built a risk management plan for medicinal product
ORGANIZATION FOR RISK MANAGEMENT IN THE INDUSTRY
Define the general principles needed to build a process for developing Risk Management Plans for a medicinal product by the Industry
RISK EVALUATION AND MITIGATION STRATEGY (REMS)
REMS principles, content, implementation, reporting and assessment. When a REMS is required ?
SCOPE AND BACKGROUND ON MEDICATION ERRORS
Most common types of medication errors and barriers to reporting them.
MEDICATION ERROR PHARMACOVIGILANCE
Sources of medication errors data, reporting requirements and medication error MeDRA terms : best practices
MINIMIZING MEDICATION ERRORS RELATED TO NOMENCLATURE
Factors that contribute to medication errors related to naming and best practices to follow when developing a proprietary name
MINIMIZING MEDICATION ERRORS RELATED TO PRODUCT DESIGN
How medication errors can be avoided at the design stage by learning from post-marketing experience?
OPTIMIZING LABELING AND PACKAGING TO MINIMIZE MEDICATION ERRORS
Best practices in designing labels to ensure critical elements of product labels and labeling are designed to promote safe use
