lecturers: safety risk management and …

SAFETY RISK

MANAGEMENT AND

PHARMACOVIGILANCE

INFARMED, Lisbon 07 - 09 march 2013

TRAINING PROGRAMME IN PHARMACEUTICAL MEDICINE

This module is a mandatory part of the curricular unit “Safety and Risk Management”. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments.

SAFETY RISK MANAGEMENT AND PHARMACOVIGILANCE 07 - 09 march 2013

LECTURERS:

Adolfo Figueiras, PharmD, PhD · Alexandra Pêgo, PharmD · Alfonso Carvajal, MD, PhD · Altamiro da Costa Pereira, MD, PhD Ana Araújo, PharmD · Andy Cochrane, PhD · Carlos Macedo, MD · Dirk Teuwen MD, PhD · Germano Ferreira, PharmD, PhD Inês Vaz, PharmD, MSc · Isabel Boaventura, MD · Jo Harper · Madalena Arriegas, PharmD · Paula Dias de Almeida, PharmD Sandra Madaleno, PharmD, MSc · Teresa Herdeiro

MODULE LEADER:

Teresa Herdeiro, PharmD, MSc, PhD Invited Professor, Health Sciences Department, University of Aveiro;Scientific Consultant, Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto

Dirk Teuwen, MD, PhD Chief Safety Officer, UCB, Belgium

ORGANISATION:

MASTERS IN PHARMACEUTICAL MEDICINESPECIALISATION COURSE IN PHARMACEUTICAL MEDICINEDirector: Luis Almeida, MD, PhD ([email protected])Deputy Director: Bruno Gago, PharmD, PhD ([email protected])Associate Director: Miguel Forte, MD, PhD ([email protected])

Health Sciences DepartmentUniversity of Aveiro | 3810-193 Aveiro | PortugalTel. +351 234 370 213 | Fax +351 234 401 597 E-mail: [email protected]

COLLABORATION

AFFILIATION

http://pharmaceutical-medicine.web.ua.pt

ENDORSEMENT EXTERNAL ACCREDITATION

Curricular unit objectives:• Toprovideanoverviewofhistoryandbackgroundofpharmacovigilance.• Toprovideanoverviewaboutthedrugsafetyduringclinicaltrials.• Toprovideanoverviewofriskmanagementsystems.• Toprovideanoverviewofmanagementandreportingofadversereactionstomedicinalproducts.• Toprovideanoverviewoftheregulatoryrequirementsforsignaldetection,interpretation,assessmentandmanagement.• Toprovideanoverviewofthecompanyresponsibilitiesinpharmacovigilance.• Todiscusschallengesinthenewpharmacovigilanceregulationandgoodparmacovigilancepractices.

Curricular unit learning outcomes:Aftercurricularunitcompletion,theparticipantwillbeableto:• UnderstandtheimportanceofcollaborativeapproachesinDrugSafety,PharmacovigilanceandPharmacoepidemiology,e.g.withacademia.• Knowthepharmacovigilancedefinitions.• Knowthehistoryofpharmacovigilance,pharmacovigilancenationalsystem,thenewregulationandtheguidelinesongoodpharmacovigilance

practices.• Identifyandclassifyadverseeventsandadversedrugreactions.• Understandtheimportanceofdrugsafetyduringclinicaltrials.• Understandtheresponsibilitiesofsponsorsandinvestigatorsinreportingadverseevents.• KnowtheEuropeanriskmanagementplanstructure,objectiveandsafetyspecifications.• Understandtheimportanceofpost-authorisationsafetystudies,thestudydesignandreporttoAuthorities.• Discussriskminimizationactivities,consideringtheirlegalandregulatoryframeworks.• KnowtheproceduresforexpeditedreportingandelectronictransmissionofICSRs.• Knowtheobjectives,formatandcontentsofperiodicupdatesafetyreporting.• UnderstandthePharmacovigilancesystemandtheprinciplesforgoodpharmacovigilancepractices.• KnowtheresponsibilitiesoftheQualifiedPersonforPharmacovigilanceintheEuropeanEconomicArea.• Knowthedefinitionofasafetysignal.• Understandthesignalmanagementprocess,detection,assessment,validationandanalysis.• DiscussissuessurroundingeffectivecrisismanagementandthecommunicationofdrugsafetyissuestoRegulatoryAuthorities,Healthcare

ProfessionalsandtheGeneralPublic.• Identifytheneedforscientificadviceandunderstandtheprocedurenecessarytoobtainscientificadvicefromaregulatorybody.

SAFETY RISK

MANAGEMENT AND

PHARMACOVIGILANCE

LECTURERS:

MODULE LEADER:

ORGANISATION:

COLLABORATION

AFFILIATION

SAFETY RISK

MANAGEMENT AND

PHARMACOVIGILANCE

LECTURERS:

MODULE LEADER:

ORGANISATION:

COLLABORATION

AFFILIATION

DAY 02 08 march 2013

WORKSHOP

#03RISK MANAGEMENT SYSTEMS CHAIRPERSON: Altamiro da Costa Pereira, MD, PhD (Full Professor, Faculty of Medicine, University of Porto; Co-coordinator of Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto)

09:00-13:00 1. Risk Management Plan, objective and structure Madalena Arriegas, PharmD (Scientific Administrator, European Medicines Agency)

2. Risk Management Plan , EU template Madalena Arriegas, PharmD (Scientific Administrator, European Medicines Agency)

3. Responsibilities for risk management within an organisation Madalena Arriegas, PharmD (Scientific Administrator, European Medicines Agency)

4. Operation of the EU network Madalena Arriegas, PharmD (Scientific Administrator, European Medicines Agency)

5. Pharmacoepidemiology, Post-authorisation safety studies Adolfo Figueiras, PharmD, PhD (Full Professor, Faculty of Medicine, University of Santiago de Compostela, Spain)

6. Risk Minimization Activities Isabel Boaventura, MD (Member of the Board of the Competence in Pharmaceutical Medicine, Ordem dos Médicos; Medical Director, Celgene)

7. Assessment and monitoring compliance Isabel Boaventura, MD (Member of the Board of the Competence in Pharmaceutical Medicine, Ordem dos Médicos; Medical Director, Celgene)

8. Case studies Isabel Boaventura, MD (Member of the Board of the Competence in Pharmaceutical Medicine, Ordem dos Médicos; Medical Director, Celgene)

This workshop introduces the principles of the guideline on good pharmacovigilance practices: Module V – Risk management systems. Presents the definitions and principles of risk management and the responsibilities for the marketing authorisation holders and competent authorities.The EU and US regulatory frameworks are reviewed and the requirements, structure and objective of a Risk Management Plan are presented and discussed, with several examples. An overview of pharmacoepidemiology, including the protocol, design, conduct and report of post-authorisation safety studies is presented. Personal experience in post-authorisation risk minimization activities and risk management plan, including issue and crisis management is shared.

WORKSHOP

#04MANAGEMENT AND REPORTING OF ADVERSE REACTIONS TO MEDICINAL PRODUCTS CHAIRPERSON: Alfonso Carvajal, MD, PhD (Full Professor, Faculty of Medicine, University of Valladolid; Member ENCePP Steering Group, of EMA)

14:30-18:00 1. Sources of safety information. Data quality management Ana Araújo, PharmD (Pharmacist of the Directorate of Risk Management for Medicines, INFARMED)

2. Expedited reporting and electronic transmission of ICSRs Ana Araújo, PharmD (Pharmacist of the Directorate of Risk Management for Medicines, INFARMED)

3. Overdose, off-label use, misuse, abuse, occupational exposure Sandra Madaleno, PharmD, MSc (Country Safety Lead, Pfizer)

4. Objectives, format and contents of PSUR Alexandra Pêgo, PharmD (Head of the Directorate of Risk Management for Medicines, INFARMED)

5. Safety evaluation and implementation of safety measures Alexandra Pêgo, PharmD (Head of the Directorate of Risk Management for Medicines, INFARMED)

This workshop introduces the principles of the guidelines on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products and Module VII – Periodic safety update report. An overview of the main sources of epidemiological pharmacovigilance information, post-marketing safety requirements and spontaneous expedited reporting in the EU and the US (spontaneous reporting post-marketing) are presented. Several definitions are introduced, such as dosage, accumulation, medication errors and interactions. Drug adherence/compliance and special situations (e.g. use during pregnancy or breastfeeding, in paediatric or elderly populations, overdose, abuse, misuse, medication error and occupational exposure) are discussed. The regulatory requirements and procedures relative to Periodic Safety Update Reports, and safety evaluation and implementation of safety measures (such as revocation, suspension, urgent safety restrictions, summary of product characteristics variation, communication to healthcare professional and general public) are reviewed.

10:00-10:30 Introduction

Teresa Herdeiro, PharmD, PhD (Invited Professor, Health Sciences Department, University of Aveiro;Scientific Consultant, Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto)

WORKSHOP

#01HISTORY AND BACKGROUND OF PHARMACOVIGILANCE CHAIRPERSON: Alexandra Pêgo, PharmD (Head of the Directorate of Risk Management for Medicines, INFARMED)

10:30-13:00 1. History of Pharmacovigilance and National System Ana Araújo, PharmD (Pharmacist of the Directorate of Risk Management for Medicines, INFARMED)

2. New European Pharmacovigilance legislation (Directive 2010/84/EU e Regulation (EU) N.º 1235/2010) Ana Araújo, PharmD (Pharmacist of the Directorate of Risk Management for Medicines, INFARMED)

3. Good pharmacovigilance practices synopsis Ana Araújo, PharmD (Pharmacist of the Directorate of Risk Management for Medicines, INFARMED)

4. Terms in Pharmacovigilance Inês Vaz, PharmD, MSc (Pharmacist, Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto)

5. The concept of benefit / risk assessment. Case studies Inês Vaz, PharmD, MSc (Pharmacist, Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto)

This workshop introduces the participants to the history of pharmacovigilance systems, in particular of the Portuguese pharmacovigilance system, and institutions that regulate and monitor drug safety. An overview of terms used in pharmacovigilance is given, as well as the assessment and classification of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and evidence for association and causality. The concept of benefit/risk assessment is introduced, and the assessment of causal relationship between the medicinal product and the adverse event is shared and discussed.

WORKSHOP

#02COLLECTION OF ADVERSE EVENTS IN CLINICAL TRIALS CHAIRPERSON: Carlos Macedo, MD (Medical Director, GlaxoSmithKline)

14:30-19:00 1. Drug safety during clinical trials Dirk Teuwen MD, PhD (Chief Safety Officer, UCB, Belgium)

2. Collection of AEs in clinical trials Dirk Teuwen MD, PhD (UCB)

3. RoIe of sponsors and investigators in reporting AEs Dirk Teuwen MD, PhD (UCB)

4. Predisposing factors in health and disease Dirk Teuwen MD, PhD (UCB)

5. Using MedDRA terms Dirk Teuwen MD, PhD (UCB)

6. EU and US regulations Dirk Teuwen MD, PhD (UCB)

This workshop introduces the participants in drug safety during clinical trials. Gives an overview about the methods to collect adverse events and the responsibilities of sponsors and investigators in reporting adverse events during clinical trials according to regulatory requirements The health and disease factors that predispose to the occurrence of adverse events are emphasized. An overview of MedDRA terms and EU and US regulations is given. During the workshop several examples and problem cases are shared and discussed.

WORKSHOP

#05COMPANY’S DRUG SAFETY AND PHARMACOVIGILANCE SYSTEM CHAIRPERSON: Dirk Teuwen, MD, PhD (Chief Safety Officer, Vice President Global Clinical Safety and Pharmacovigilance, UCB)

09:00-13:00 1. Pharmacovigilance system, principles for good pharmacovigilance practices Andy Cochrane, PhD (deputy EUQPPV, Novartis, UK)

2. The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area Andy Cochrane, PhD (deputy EUQPPV, Novartis, UK)

3. Quality Management / Pharmacovigilance systems and their scope Jo Harper (Director, Head of PVQA, UCB)

4. Pharmacovigilance inspections Jo Harper (Director, Head of PVQA, UCB)

5. Safety communication Andy Cochrane (Novartis), Jo Harper and Dirk Teuwen (UCB)

This workshop introduces the principles of the guidelines on good pharmacovigilance practices Module I – Pharmacovigilance systems and their quality systems. Personal experience in design of Standard Operating Procedures (SOPs), audits and inspections in pharmacovigilance is given. Post-authorisation risk management including issue and crisis management and risk communication are discussed and shared with some examples.

WORKSHOP

#06SIGNAL MANAGEMENT CHAIRPERSON: Paula Dias de Almeida, PharmD (Member of Executive Board of INFARMED)

14:30-17:30 1. Sources of data and information Germano Ferreira, PharmD, PhD (Senior Manager, Lead of Observational Database Analysis, GSK Vaccines, Belgium)

2. Methodology for signal detection Germano Ferreira, PharmD, PhD (Senior Manager, Lead of Observational Database Analysis, GSK Vaccines, Belgium)

3. Signal management process, detection, validation and analysis Germano Ferreira, PharmD, PhD (Senior Manager, Lead of Observational Database Analysis, GSK Vaccines, Belgium)

4. Signal assessment Germano Ferreira, PharmD, PhD (Senior Manager, Lead of Observational Database Analysis, GSK Vaccines, Belgium)

5. Quality requirements Germano Ferreira, PharmD, PhD (Senior Manager, Lead of Observational Database Analysis, GSK Vaccines, Belgium)

This workshop introduces the definition of safety signal, and the regulatory requirements for signal detection, interpretation and management. An overview of signal evaluation, developing and managing company core safety information and product labelling is given.The final round-table aims to give a perspective about the company, authorities and universities about the role of the pharmaceutical professional in drug safety and pharmacovigilance.

ROUND-TABLECHAIRPERSON: Paula Dias de Almeida, PharmD (Member of Executive Board of INFARMED)The role of the pharmaceutical professional in drug safety and pharmacovigilance Alexandra Pêgo (INFARMED), Dirk Teuwen (UCB) & Teresa Herdeiro (University of Aveiro)

WORKSHOP

lecturers: safety risk management and …

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