Eu2P MASTER : TRACKS & OBJECTIVES

Speciality : BENEFIT ASSESSMENT OF MEDICINES

OBJECTIVES

• Clinical and pharmacological principles
• Patients' therapeutic needs, medicines and society.
• - Patients, physicians, information and prescribing.
• - Clinical and pharmacological basis of therapeutics.
• - Variability in medicines response.
• - Therapeutics and medicines prescribing of medicines for selected health problems.
• Methods in clinical research, pharmacoepidemiology and in the assessment of the efficacy of medicines
• - Scientific methods and causality.
• - Statistical and methodological issues for the design and analysis of clinical trials.
• - Ethical issues in the development of clinical research and clinical trials.
• - Systematic review and meta-analysis of randomised clinical trials.
• - Other methods for the evaluation of the effectiveness of medicines and therapeutic interventions.
• Critical appraisal of clinical trials: evidence-based medicine and its uncertainties
• - Randomised clinical trials limitations.
• - Evidence-based medicine and its limitations.
• - Critical appraisal of randomised clinical trials limitations.
• - Critical appraisal of a meta-analysis of randomised clinical trials.
• - From therapeutic uncertainty to a research protocol

MODULE LIST

• Integrated Clinical and Translational Pharmacology
• Clinical Research Methods and Real-World Effectiveness Assessment
• Critical Evaluation of Clinical Trials and Evidence-Based Medicine

Speciality : MEDICINES RISK IDENTIFICATION AND QUANTIFICATION

OBJECTIVES

• This domain team develops all contents related to medicines risk identification and quantification such as:
• Principles of identifying and recognizing adverse events and safety signals
• - Definition of adverse drug reactions - type of ADRs
• - Detection and recognition of adverse events in clinical trials
• - Adverse event coding principles and differences
• - Spontaneous reporting databases
• - Principles of signal detection on electronic health care databases
• - Risk management plans
• Substantiation and quantification of risks
• - Introduction: from case based reasoning to population based reasoning, examples: Augmentin, H1N1 vaccination, Yellow fever vaccine
• - Theory of causality: causality from different perspectives, validity & causal diagrams, plausibility & substantiation
• - Designing a study: study designs, basic epidemiological measures, data sources, workflow to quantify risks, case and exposure identification, codes of conduct, writing a protocol
• - Data analysis: SAS, raw data to metrics, elementary and advanced analysis, controlling confounding, Bayesian methods, sensitivity analysis, meta-analysis
• - Communication of results: communication with academia, regulators, pharmaceutical industry, writing a pharmacoepidemiological paper
• Identifying susceptibility for adverse drug reactions
• - Introduction, risk factors and effect modification
• - Variability in drug response and principles of pharmacogenetics/pharmacogenomics
• - Assessment of pharmacogenetic influence through candidate genes and genome-wide association studies (GWAS)
• - Ongoing initiatives and biological interpretation
• - Successes and failures in pharmacogenetic studies

MODULE LIST

• Safety Signal Detection and Adverse Event Management
• Quantitative Risk Assessment and Benefit-Risk Modeling
• Risk Factors and Patient Susceptibility to Adverse Drug Reactions

Speciality : MEDICINES BENEFIT-RISK ASSESSMENT

OBJECTIVES

• This domain team develops all contents related to medicines benefit-risk assessment such as:
• Introduction to benefit-risk assessment and pharmacoeconomics in decision making
• - Introduction
• - Benefits
• - Risk/Harms
• - Principles and methods of comparative benefit-risk assessment
• - Principles of Pharmacoeconomics
• Principles of pharmacoeconomics and valuation of health states
• - Introduction
• - Costs
• - Effects
• - Pharmacoeconomic analysis
• - How to perform a good pharmacoeconomic evaluation
• Fundamentals of quantitative benefit-risk assessment methods
• in decision making on medicines
• - Introduction to benefit-risk analysis methods
• - Benefit/Risk assessment during life cycle of medicines
• - Measures based on statistics/simulation
• - Health outcomes models
• Advanced quantitative benefit-risk assessment methods in decision making on medicines
• - Multi-criteria decision analysis
• - Conjoint analysis
• - Personalized benefit-risk assessment

MODULE LIST

• Benefit-Risk and Health Economics for Strategic Decision-Making
• Advanced Analytics for Benefit-Risk and Regulatory Decisions
• Health Outcomes and Economic Valuation of Health States
• Quantitative Benefit-Risk Analysis and Decision Modeling

Speciality : MEDICINES AND PUBLIC HEALTH

OBJECTIVES

• Drug utilisation studies: introduction and quantitative methods
• - Measurement of drug use
• - Overview of drug utilisation studies (DUS)
• - Quantitative measures of drug utilisation.
• - Design of quantitative DUS
• - How to read papers on quantitative DUS
• Drug utilisation studies: qualitative methods
• - Sources of data and standards to compare with.
• - Methods to identify how medicines are used in the community (1) - prescription vs. indication and indication vs. prescription
• - Methods to identify how medicines are used in the community (2) - cohort and case-controls studies as a source of drug utilisation data
• - Design of qualitative DUS: Objectives, methods and discussion of proposals
• - How to read papers on qualitative DUS. Limitations of DUS
• The public health impact of adverse drug reactions
• - Data generalization: from particular cases to population impact-1. The interpretation of the results of clinical trials and meta-analyses from the public health point of view
• - Data generalization: from particular cases to population impact-2. Examples of the value of observational studies and meta-analyses of observational studies in the evaluation of the public health impact of medicines use.
• - Public health impact - Case: Hormone replacement therapy
• - Public health impact beyond case-control studies
• - The importance of the denominator: case-population studies. The future of pharmacovigilance.

MODULE LIST

• Quantitative Drug Utilisation and Prescribing Pattern Analysis
• Qualitative Methods in Drug Utilisation and Healthcare Research
• Public Health Impact of Adverse Drug Reactions

Speciality : MEDICINES RISK COMMUNICATION

OBJECTIVES

• Information and communication about benefit-risk of medicines. Basic principles.
• - Principal actors in communication on medicines risk, of traditional and new forms of communication, of routes of communication and their evolution through time
• - Basis of risk communication process
• - Regulatory Responsibilities and Requirements Concerning Medicines Risk Communication
• - Communication of actual and alleged risks associated to medicines: three different scenarios
• Key roles and stakeholders in medicines risk communication: duties and challenges
• - Historical perspective. Evolution of concept of risk communication. Social impact of drug risk communication
• - Risk perception. Actual vs perceived and factors influencing perception. Population vs individual risk perception
• - Concept of uncertainty. How to deal with this in risk communication
• - Nature and importance of communication of risk of medicines: accessibility of data, conflict of interest and independent information
• - Regulatory agencies' strategies to address the challenges of risk communication
• Case studies in medicines risk communication
• - Hepatitis B vaccine in France, pandemic influenza vaccines, HRT and cancer. What can we learn? What could have been done?
• - Communication aspects based on drug withdrawals: e.g. rofecoxib, rosiglitazone, benfluorex. What can we learn? What could have been done?
• - How to measure the effectiveness of risk communication

MODULE LIST

• Effective Communication of Benefit-Risk Information
• Stakeholder Engagement and Crisis Communication in Drug Safety
• Applied Risk Communication: Industry Case Studies

INTEGRATED CLINICAL AND TRANSLATIONAL PHARMACOLOGY

OBJECTIVES

• To analyse and discuss the role and the impact of medicines in therapeutics, health services and society.

• To understand the pharmacological and clinical essential principles of prescribing.

• To understand the pharmacological, clinical and epidemiological principles underlying the effects (both beneficial and unwanted) of medicines in various populations.

• To analyse and discuss the relevance of unbiased, updated information for prescribing.

• To discuss and practice the selection of medicines for patients with specific disease.

• To discuss and analyse the need to keep studying the effects of medicines in populations in general medical practice.

MODULE PARTS

• Patients' therapeutic needs, medicines and society.
• Patients, physicians, information and prescribing.
• Clinical and pharmacological basis of therapeutics.
• Variability in medicines response.
• Therapeutics and medicines prescribing of medicines for selected health problems.

TRAINER TEAM

Coordinator: Dr Antònia Agustí (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Dr Montse Bosch, Melani Nuñez Montero (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

CLINICAL RESEARCH METHODS AND REAL-WORLD EFFECTIVENESS ASSESSMENT

OBJECTIVES

• To develop a robust knowledge and familiarity with the methods used in clinical research and pharmacoepidemiology to evaluate the efficacy and effectiveness of medicines and therapeutic interventions.

• To develop a robust knowledge and familiarity with the methods used in randomised clinical trials.

• To analyse and discuss ethical and legal issues in clinical research and randomised clinical trials.

• To understand principles of synthesizing scientific data through systematic review and meta-analysis of clinical trials.

• To acquire a specialised and robust knowledge of specialized requisites in the design and interpretation of clinical trials in specific areas

MODULE PARTS

• Scientific methods and causality.
• Statistical and methodological issues for the design and analysis of clinical trials.
• Ethical issues in the development of clinical research and clinical trials.
• Systematic review and meta-analysis of randomised clinical trials.
• Other methods for the evaluation of the effectiveness of medicines and therapeutic interventions.

TRAINER TEAM

Coordinator: Dr Antònia Agustí (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Melani Nuñez Montero (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

CRITICAL EVALUATION OF CLINICAL TRIALS AND EVIDENCE-BASED MEDICINE

OBJECTIVES

• To analyse and discuss strengths and limitations of randomised clinical trials and other epidemiological studies.

• To analyse and discuss strengths and limitations of evidence-based medicine.

• To undertake complete critical appraisals of different randomised clinical trials and meta-analysis of randomised clinical trials.

• To identify the essential questions that remain to be studied for a given health problem.

• To translate a therapeutic uncertainty into a research hypothesis and a research study protocol.

MODULE PARTS

• Randomised clinical trials limitations.
• Evidence-based medicine and its limitations.
• Critical appraisal of randomised clinical trials limitations.
• Critical appraisal of a meta-analysis of randomised clinical trials.
• From therapeutic uncertainty to a research protocol

TRAINER TEAM

Coordinator: Dr Antònia Agustí (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Dr Montse Bosch (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

EU AND GLOBAL PHARMACOVIGILANCE REGULATORY FRAMEWORKS

OBJECTIVES

• To enable you to develop an understanding of European, USA and major local and worldwide regulations and guidelines concerning pharmacovigilance.

• Emphasis will be placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-authorisation.

MODULE PARTS

• Pharmacovigilance regulations: concept
• The working Pharmacovigilance regulations.
• Other related Pharmacovigilance regulations and guidelines.
• Non-European pharmacovigilance regulations

TRAINER TEAM

Coordinator: Sue Rees (University of Hertfordshire)

Experts: Dr Sherael Webley (University of Hertfordshire), Dr Jens-Ulrich Stegmann, Subhash Mistry (GlaxoSmithKline Research and Development Ltd), Edward Stewart Geary (Eisai), Dr John Poustie (Norgine), Dr James Whitehead (AstraZeneca AB), Caroline Rainsford (Cosmetic, Toiletry and Perfumery Association), Mark Baczkowski (Sutro Biopharma, Inc.)

PHARMACOVIGILANCE PROCESSES, SUBMISSIONS AND INSPECTIONS

OBJECTIVES

• To enable you to develop an understanding of the requirements of the Pharmaceutical Industry’s operational aspects of pharmacovigilance as it relates to the preparation and assessment of documents legally required by regulatory bodies.

• Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.

MODULE PARTS

• Case reporting
• Periodic reporting
• Product Labelling and Risk Management Plans
• Contractual arrangements.

TRAINER TEAM

Coordinator: Sue Rees (University of Hertfordshire)

Experts: Dr Sherael Webley, Bharat Amlani, Jabeen Ahmadi (University of Hertfordshire), John Talbot, Dr James Whitehead, Dr Jane Feron (AstraZeneca AB), Dr Justina Orleans-Lindsay (Acadustri Ltd), Robert Grice, Dr Michael Perrio (GlaxoSmithKline Research and Development Ltd), Helen Robinson (Pfizer), Dr David Lewis, Dr Marion Mueller (Novartis Pharma AG), Philippa Guy (Saffron Health), Dr Sarah Hall (Baxter International Inc.), Dr Susan Duke (F. Hoffmann-La Roche Ltd)

SAFETY SIGNAL DETECTION AND ADVERSE EVENT MANAGEMENT

OBJECTIVES

• To enable you to develop an understanding of current practice in identifying adverse drug reactions and safety signals

• To be able to classify events, identify signals and understand the follow-up procedure

MODULE PARTS

• Definition of adverse drug reactions - type of ADRs
• Detection and recognition of adverse events in clinical trials
• Adverse event coding principles and differences
• Spontaneous reporting databases
• Principles of signal detection on electronic health care databases
• Risk management plans

TRAINER TEAM

Coordinator: Dr Katia Verhamme (Erasmus Universitair Medisch Centrum)

Experts: Dr Martijn Schuemie (Janssen Pharmaceutica NV), Dr Patrice Verpillat, Dr Sebastian Monzon (European Medicines Agency), Dirk Teuwen, Dr Peter Verdru (UCB Pharma SA), Dr Barbara Donner, Dr Fraser Mccallum, Dr James Stevens (F. Hoffmann-La Roche Ltd), Prof Bruno Stricker, Dr Sandra De Bie, Giorgia Pellegrini (Erasmus Universitair Medisch Centrum), Dr Laurent Auclert, Dr Juhaeri Juhaeri (Sanofi-aventis Recherche et Développement), Dr Ugo Moretti (Università di Verona), Dr Gianluca Trifiro (Università degli studi di Messina), Dr Sabine Straus, Dr Fakhredin Sayed Tabatabaei (Dutch Medicines evaluation Board), Dr Paul Avillach (Harvard Medical School), Dr Fariba Ahmadizar (University Medical Center Utrecht)

QUANTITATIVE RISK ASSESSMENT AND BENEFIT-RISK MODELING

OBJECTIVES

• This course is an advanced training with focus on quantitative aspects and modern statistics applied to pharmacoepidemiological studies aimed at hypothesis testing. You are required to know how to use basic regression models to follow this training.

• At the end of this course, you will

• 3. Understand how data on adverse drug events derived from analysis of individual patients can lead to inferences regarding populations
  6. Know the various study designs in pharmacoepidemiology and to determine which study design is appropriate to address specific safety issues
  9. Be familiar with basic statistical concepts and techniques as applied to pharmacoepidemiology
  12. Understand and assist in pharmacoepidemiological studies using large healthcare databases
  15. Understand the process of risk communication from the point of view of different stakeholders

MODULE PARTS

• Introduction: from case based reasoning to population based reasoning
• Designing a study: study designs, basic epidemiological measures, data sources, workflow to quantify risks, case and exposure identification, codes of conduct, writing a protocol
• Designing a study II: Causality from different perspectives, Causal diagrams, and Building a Statistical Analysis Plan
• Raw Data to Metrics: Elementary and advanced analysis methods with an introduction to data analysis in R
• Communication of results: communication with academia, regulators, pharmaceutical industry, writing a pharmacoepidemiological paper

TRAINER TEAM

Coordinator: Prof Miriam Sturkenboom (University Medical Center Utrecht)

Experts: Prof Nicholas Moore (Université de Bordeaux), Dr Martijn Schuemie (Janssen Pharmaceutica NV), Dr Katia Verhamme, Dr Odette De Bruin (Erasmus Universitair Medisch Centrum), Dirk Teuwen (UCB Pharma SA), Noah Jamie Robinson, Dr George Quartey, Dr Preciosa Coloma, Dr Philippe Van Der Auwera, Dr Bharat Thakrar (F. Hoffmann-La Roche Ltd), Dr Gianluca Trifiro (Università degli studi di Messina), Dr Sabine Straus (Dutch Medicines evaluation Board), Dr Silvana Romio, Dr Caitlin Dodd, Vjola Hoxhaj, Maryam Hosseini Ryvandi (University Medical Center Utrecht), Dr Hans Petri (Petri Consulting Ltd)

RISK FACTORS AND PATIENT SUSCEPTIBILITY TO ADVERSE DRUG REACTIONS

OBJECTIVES

• To understand effect modification

• To understand the principles of genetic susceptibility for drug risks

MODULE PARTS

• Susceptibility: history and introduction
• Variability in drug response and principles of pharmacogenetics/pharmacogenomics
• Assessment of pharmacogenetic influence through candidate genes and genome-wide association studies (GWAS)
• Mendelian randomization in pharmacoepidemiology
• Epigenomics, transcriptomics, proteomics in pharmacoepidemiology

TRAINER TEAM

Coordinator: Dr Katia Verhamme (Erasmus Universitair Medisch Centrum)

Experts: Prof Bruno Stricker, Dr Loes Visser, Dr Teun Van Gelder, Prof Cornelia M. Van Duijn, Dr Ron Van Schaik, Prof André G Uitterlinden, Dr Lies Lahousse, Giorgia Pellegrini (Erasmus Universitair Medisch Centrum), Dr Fariba Ahmadizar (University Medical Center Utrecht)

BENEFIT-RISK AND HEALTH ECONOMICS FOR STRATEGIC DECISION-MAKING

OBJECTIVES

• The objective of the module is to gain insight in the role of benefit-risk assessment and pharmacoeconomics in the process of decision-making on medicines by different stakeholders.

• At the end of this module, you will be able to:

• delineate the process of decision-making and the perspectives of the stakeholders involved

• explain the rationale of benefit-risk assessment and pharmacoeconomic evaluation

• evaluate the methodology and results of benefit-risk and pharmaco-economic studies

• translate of the results into the process of decision-making

MODULE PARTS

• Introduction
• Benefits
• Risk/Harms
• Principles and methods of comparative benefit-risk assessment
• Principles of Pharmacoeconomics

TRAINER TEAM

Coordinator: Dr Shahab Abtahi (Universiteit Utrecht)

Experts: Prof Olaf Klungel, Dr Rob Heerdink, Tu Trang, Dr Christine Leopold, Sage Wyatt (Universiteit Utrecht)

HEALTH OUTCOMES AND ECONOMIC VALUATION OF HEALTH STATES

OBJECTIVES

• Decision making on medicines informed by quantitative benefit-risk assessment may differ depending on the perspective of the decision maker and the phase of drug development. This module will address the decision-making on medicines by different stakeholders during the life cycle of a drug and how benefit-risk assessment tools may be applied in this process. Principles and fundamental methodologies for quantitative benefit/risk assessment, the strengths and weaknesses of these methodologies, and how to apply these methodologies in practice, will be discussed.

• At the end of this module, you will be able to:

• Describe principles and methods of comparative BR assessment

• Apply different fundamental quantitative B-R assessment methods in an example case

• Interpret results of quantitative B-R assessment and translate the results into the process of decision making

• Evaluate the results of quantitative B-R assessment and identify limitations of B-R methods

MODULE PARTS

• Introduction to benefit-risk analysis methods
• Benefit/Risk assessment during life cycle of medicines
• Measures based on statistics/simulation
• Health outcomes models

TRAINER TEAM

Coordinator: Dr Jet Van Der Zijden (Universiteit Utrecht)

Experts: Prof Olaf Klungel, Prof Toine Pieters, Prof Marieke De Bruin, Sage Wyatt (Universiteit Utrecht)

QUANTITATIVE BENEFIT-RISK ANALYSIS AND DECISION MODELING

OBJECTIVES

• Decision making on medicines informed by quantitative benefit-risk assessment may differ depending on the perspective of the decision maker and the phase of drug development.

• This module will address the decision-making on medicines by different stakeholders and how to apply advanced benefit-risk assessment tools in this process.

MODULE PARTS

• Multi-criteria decision analysis
• Conjoint analysis
• Personalized benefit-risk assessment

TRAINER TEAM

Coordinator: Dr Shahab Abtahi (Universiteit Utrecht)

Experts: Prof Olaf Klungel (Universiteit Utrecht)

ADVANCED ANALYTICS FOR BENEFIT-RISK AND REGULATORY DECISIONS

OBJECTIVES

• Economic considerations play an important role in decision-making on medicines, e.g. for pricing and reimbursement purposes. Insight in the strengths and weaknesses of the different economic evaluation techniques is needed for improved decision making on medicines.

• The objective of this module is to gain insight into different preference valuation techniques and (pharmaco)economic evaluation methods.

• At the end of this module, you will be able to:

• describe the elements and scope of Health Technology Assessment (HTA)

• execute a cost study and how to take into account the perspective in such studies

• calculate the different effect measures used in pharmacoeconomics

• describe the different approaches for valuation of health states and to interpret these values

• conduct a pharmacoeconomic analysis including all relevant aspects(incremental cost-effectiveness ratio (ICER), type of outcome analysis including differential timing, health outcomes models, and sensitivity analysis)

• evaluate the quality of a pharmacoeconomic evaluation study

• design a pharmacoeconomic study (extended version)

MODULE PARTS

• Introduction
• Costs
• Effects
• Pharmacoeconomic analysis
• How to perform a good pharmacoeconomic evaluation

TRAINER TEAM

Coordinator: Dr Christine Leopold (Universiteit Utrecht)

Experts: Dr Anke Hovels, Dr Talitha Verhoef, Dr Geert Frederix, Joost Geenen, Sage Wyatt (Universiteit Utrecht), Dr Hans Tamminga (GlaxoSmithKline Research and Development Ltd)

QUANTITATIVE DRUG UTILISATION AND PRESCRIBING PATTERN ANALYSIS

OBJECTIVES

• To understand the need to study how medicines are used.

• To describe the general characteristics of the different methods to study the use of medicines, and to identify them.

• To know the different methods and measures that allow quantitative approach to medicines utilisation.

• To carry out critical appraisal of quantitative drug utilisation studies.

• To design, to carry out and to analyze quantitative studies of medicines utilisation in different clinical settings.

MODULE PARTS

• Measurement of drug use
• Overview of drug utilisation studies (DUS)
• Quantitative measures of drug utilisation.
• Design of quantitative DUS
• How to read papers on quantitative DUS

TRAINER TEAM

Coordinator: Dr Imma Danés (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Dr Antònia Agustí, Dr Xavier Vidal, Melani Nuñez Montero (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Noah Jamie Robinson (F. Hoffmann-La Roche Ltd), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

QUALITATIVE METHODS IN DRUG UTILISATION AND HEALTHCARE RESEARCH

OBJECTIVES

• To understand the need to design and to carry out qualitative drug utilisation research.

• To be able to critically appraise qualitative drug utilisation studies (DUS).

• To design, to implement and to discuss small-scale audits on the quality of medicines use in hospitals and in primary health care.

MODULE PARTS

• Sources of data and standards to compare with.
• Methods to identify how medicines are used in the community (1) - prescription vs. indication and indication vs. prescription
• Methods to identify how medicines are used in the community (2) - cohort and case-controls studies as a source of drug utilisation data
• Design of qualitative DUS: Objectives, methods and discussion of proposals
• How to read papers on qualitative DUS. Limitations of DUS

TRAINER TEAM

Coordinator: Dr Imma Danés (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Dr Antònia Agustí, Dr Xavier Vidal, Melani Nuñez Montero (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Noah Jamie Robinson (F. Hoffmann-La Roche Ltd), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

PUBLIC HEALTH IMPACT OF ADVERSE DRUG REACTIONS

OBJECTIVES

• To critically use data from experimental and observational studies to evaluate the public health impact of selected adverse drug reactions.

• To design and to carry out an analysis of the impact of adverse effects at a community level.

• To analyse the economic impact of adverse drug reactions on public health.

MODULE PARTS

• Data generalization: from particular cases to population impact-1. The interpretation of the results of clinical trials and meta-analyses from the public health point of view
• Data generalization: from particular cases to population impact-2. Examples of the value of observational studies and meta-analyses of observational studies in the evaluation of the public health impact of medicines use.
• Public health impact - Case: Hormone replacement therapy
• Public health impact: Beyond case - Control studies
• The importance of the denominator: case-population studies. The future of pharmacovigilance.

TRAINER TEAM

Coordinator: Dr Imma Danés (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Dr Antònia Agustí, Dr Xavier Vidal, Melani Nuñez Montero (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Noah Jamie Robinson (F. Hoffmann-La Roche Ltd), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

EFFECTIVE COMMUNICATION OF BENEFIT-RISK INFORMATION

OBJECTIVES

• This module will address medicines risks communication and its place within the frame of communication on medicines.

• Objectives:

• To identify the key roles, routes and tools of communication on medicines and their risks

• To know the evolution of medicines risk communication and overview of the regulatory responsibilities and requirement

• To be aware of environmental drug impact communication

MODULE PARTS

• Principal actors in communication on medicines risk, of traditional and new forms of communication, of routes of communication and their evolution through time
• Basis of risk communication process
• Regulatory Responsibilities and Requirements Concerning Medicines Risk Communication
• Communication of actual and alleged risks associated to medicines: three different scenarios

TRAINER TEAM

Coordinator: Prof Annalisa Capuano (Università degli Studi della Campania Luigi Vanvitelli)

Experts: Christa Naboulet (Université de Bordeaux), Prof Giampaolo Velo (Università di Verona), Bruce Hugman (Independent), Dr Cristina Scavone, Dr Annamaria Mascolo, Prof Liberata Sportiello, Dr Cecilia Cagnotta, Dr Antonietta Anatriello (Università degli Studi della Campania Luigi Vanvitelli), Luca Carra (Zadig Communication), Dr Heidi Larson (London School of Hygiene and Tropical Medecine)

STAKEHOLDER ENGAGEMENT AND CRISIS COMMUNICATION IN DRUG SAFETY

OBJECTIVES

• This module will address in more depth the challenges (rationale , emotional and logistical) of Risk communication that have been raised in previous modules.

• Objectives:

• To consider the evolution and social impact of the concept of risk and benefit risk

• To explore the understanding of risk perception and uncertainty

• To consider challenges in healthcare providers-patients communication

• To know the regulatory agencies strategies to address the challenges of risk communication

MODULE PARTS

• Risk communication in health: evolution of concepts and social impact of drugs
• Risk perception. Actual vs perceived and factors influencing perception. Population vs individual risk perception
• Concept of uncertainty. How to deal with this in risk communication
• Nature and importance of communication of risk of medicines: accessibility of data, conflict of interest and independent information
• Regulatory agencies' strategies to address the challenges of risk communication

TRAINER TEAM

Coordinator: Prof Daniel Catalán Matamoros (Université de Bordeaux)

Experts: Christa Naboulet, Dr Paul Benkimoun (Université de Bordeaux), Dr Catherine De Whalley (AstraZeneca AB), Dr Anita Conforti (Università di Verona), Pr Frederic Bouder (University of Maastricht), Pr William Dab (Conservatoire National des Arts et Métiers), Dr Peter Mol (Dutch Medicines evaluation Board), Prof Annalisa Capuano, Dr Cristina Scavone, Dr Annamaria Mascolo (Università degli Studi della Campania Luigi Vanvitelli), Dr Pietro Dri (Zadig Communication), Dr Giovanni Tognoni (Mario Negri Institute for Pharmacological Research), Dr Gregory Busse (Supernus Pharmaceuticals, Inc.), Dr Gerald Dal Pan (U.S. Food & Drug Administration)

APPLIED RISK COMMUNICATION: INDUSTRY CASE STUDIES

OBJECTIVES

• To analyse and discuss notable examples with special attention to the risk communication aspects

• To analyse the role of media, internet, scientific journals, independent bulletin of information

• To measure the effectiveness of risk communication as a minimisation strategy and consider ways of improving its effectiveness

MODULE PARTS

• Vaccines risk communication, pandemic influenza vaccines, Hormone Replacement Therapy (HRT) and cancer
• Risk communication in pharmacovigilance: from historical crises to current solutions
• How to measure the effectiveness of risk communication
• Active participation

TRAINER TEAM

Coordinator: Prof Daniel Catalán Matamoros (Université de Bordeaux)

Experts: Dr Annie Fourrier-Réglat, Christa Naboulet, Prof Bernard Bégaud, Prof Nicholas Moore, Dr Paul Benkimoun (Université de Bordeaux), Jon Cohen (Science), Prof Annalisa Capuano, Dr Cristina Scavone, Dr Annamaria Mascolo (Università degli Studi della Campania Luigi Vanvitelli), Prof Baruch Fischhoff (Carnegie Mellon University), Dr Ariel Arias (Health Canada), Andrew Jack (The Financial Times), Giuseppe Traversa (Istituto Superiore di Sanità), Dr Deborah Cohen (British Medical Journal)

PHARMACOVIGILANCE AUDITING AND INSPECTIONS

OBJECTIVES

• This module intends to enable you to explore the background of regulatory inspections in pharmacovigilance and auditing the pharmacovigilance process.

• You will also develop an understanding of aspects of key PV documentation, the PV auditing process, audit reports, corrective action plans and remote audits.

• The course is designed both for students new to pharmacovigilance and pharmacovigilance professionals to provide them with insight into developing a pharmacovigilance audit program. In order to gain maximum benefit from the course, an understanding of pharmacovigilance is necessary.

MODULE PARTS

TRAINER TEAM

Coordinator: Prof Annalisa Capuano (Università degli Studi della Campania Luigi Vanvitelli)

Experts: Dr Cristina Scavone, Dr Annamaria Mascolo, Fabiana Auricchio (Università degli Studi della Campania Luigi Vanvitelli), Rebecca Noss (Noss Research Consulting LLC)