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EMA Excellence in Pharmacovigilance: Clinical trials and post-marketing

Oct 13 2014 8:00AM - Oct 17 2014 12:45PM | European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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Overview 

This course is designed to provide a firm grounding in key aspects of Global and mainly European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course, presented by the European Medicines Agency, now also includes highlights and updates on the implementation of the new pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

DEFINITIONS AND METHODS IN PHARMACOVIGILANCE (TOPIC 1)

Topic 1 will provide a concise overview of the objectives and the scope of Pharmacovigilance and Risk Management and the relationship between the two concepts. The development of key definitions based on Community legislation and consensus fora such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the CIOMS Working Groups will be summarised. Practical examples and exercises will be used to illustrate the key definitions and vocabulary applied in Pharmacovigilance.


REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES (TOPIC 2)

The roles and responsibilities of marketing authorisation holders and national Competent Authorities in the conduct of Pharmacovigilance are defined in EU legislation and further detailed in the Good Pharmacovigilance Practices (GVP). Topic 2 will provide a concise summary of the individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase and illustrations based on practical case studies.

Furthermore, the roles and responsibilities of all stakeholders of interventional clinical trials, in line with the implementing texts published in relation to Directive 2001/20/EC, are summarised.

Aspects that need to be taken into account in establishing a Pharmacovigilance database as well as the key functionalities of the EU’s EudraVigilance system will be discussed.

The main elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules, the elaboration of Standard Operating Procedures (SOPs) and the preparation for audits and inspections.


DIAGNOSIS AND MANAGEMENT OF ADVERSE DRUG REACTIONS (TOPIC 3)

Pharmacovigilance is first based on the medical assessment of the adverse events passively or actively collected in organised schemes. It is then essential to be able to identify consistently the nature of events, their seriousness, their likelihood of occurrence and to assess causality with the suspect drug(s). This session will provide clues for the recognition of two serious events involving target organs of drug toxicity.

SIGNAL DETECTION (TOPIC 4)

New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. This session will provide an understanding of safety data classification, using MedDRA terminology and Standardised MedDRA Queries (SMQs) and approaches to signal detection using traditional and quantitative methods.

RISK MANAGEMENT (TOPIC 5)

In accordance with the GVP Module V on Risk Management System, risk management plans (RMPs) should be submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust epidemiological methods.

This session aims to provide the background for understanding drug-related risks, to review epidemiological methods for detecting signals and assessing risks, and to present recent developments regarding risk communication.

Continuing Education

The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom has accredited this training course with 25 CPD credits.

The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 34 credits.

Who Should Attend 

Professionals involved in pharmacovigilance and namely Qualified Persons for Pharmacovigilance (EU QPPV), clinical research, regulatory affairs, risk management, medical product safety assessment, and data analysis, epidemiology, labelling, quality assurance, compliance, medical information.

Level: Intermediate

Learning Objectives 

For the five key topics as outlined below, the learning objectives also include the ability to:

  • Describe the main changes to the business processes in the context of the new pharmacovigilance legislation
  • Discuss the latest developments in the area of international harmonisation and standardisation with the main focus on the ICH E2B, E2C, E2F

DEFINITIONS AND METHODS IN PHARMACOVIGILANCE (TOPIC 1)

  • Describe the scope and objectives of Pharmacovigilance and Risk Management and the relationship between the two concepts
  • Discuss the development of definitions based on legislation and consensus fora
  • Identify the key definitions and the vocabulary used in Pharmacovigilance in the European Union, illustrated by practical examples and exercises
  • Explain and illustrate methods used in pharmacoepidemiology for measuring risks and estimating their association with drug exposure

REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES (TOPIC 2)

  • Describe the European regulatory requirements in Pharmacovigilance
  • Describe the requirements of establishing a Pharmacovigilance database and the use of the Medical Dictionary for Regulatory Activities (MedDRA) including the key functionalities of EudraVigilance
  • Discuss the Pharmacovigilance System Master File and the preparation for audits and inspections

DIAGNOSIS AND MANAGEMENT OF ADVERSE DRUG REACTIONS (TOPIC 3)

  • Discuss the key elements of the medical evaluation of adverse events
  • Recognise the important aspects in evaluating adverse events based on two examples
  • Identify the main characteristics of two examples of drug induced adverse events

SIGNAL DETECTION (TOPIC 4)

  • Understand MedDRA dictionary
  • Describe signal detection and management in the EU, based on GVP module IX

RISK MANAGEMENT (TOPIC 5)

  • Explain the EU risk management strategy, the new approaches to risk assessment and prevention, and the different steps to be considered in the risk management process
  • Describe the components of the Good Pharmacovigilance Practices (GVP) module V on the risk management systems
  • Define the concept of risk, and explain differences between individual and population risks
  • Describe current recommendations and practices of benefit-risk assessment, post-authorisation efficacy studies and post-authorisation safety studies
  • Understand the main principles of risk communication based on case studies

Hotel & Travel 

Training course location:
European Medicines Agency
Churchill Place 30
Canary Wharf
E14 5EU London
United Kingdom

Please see below website for conveniently located hotels:
http://www.londontown.com/hotels/

Contact Information 

Registration Questions
DIA Europe, Middle East and Africa
Contact Center
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Migle Skadauskaite, Event Planner
Phone: +41 61 225 51 43
Fax: +41 61 225 51 52
migle.skadauskaite@diaeurope.org

Faculty 

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Agenda  

Day 1 Monday, Oct 13, 2014

  • 8:00AM - 8:30AM (GMT Standard Time)

    REGISTRATION
  • 8:30AM - 9:15AM (GMT Standard Time)

    Keynote Presentation: THE ROLE OF THE EUROPEAN MEDICINES AGENCY IN PHARMACOVIGILANCE
  • 9:15AM - 10:30AM (GMT Standard Time)

    Topic 1 Session 1: BASIC DEFINITIONS AND TOOLS IN PHARMACOVIGILANCE
  • 10:30AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:45PM (GMT Standard Time)

    Topic 1 Session 1 continued: BASIC DEFINITIONS AND TOOLS IN PHARMACOVIGILANCE
  • 12:45PM - 1:45PM (GMT Standard Time)

    LUNCH
  • 1:45PM - 3:30PM (GMT Standard Time)

    Topic 1 Session 2: CLASSICAL METHODS IN PHARMACOVIGILANCE
  • 3:30PM - 4:00PM (GMT Standard Time)

    COFFEE BREAK
  • 4:00PM - 6:00PM (GMT Standard Time)

    Topic 1 Session 3: EPIDEMIOLOGICAL METHODS AND PHARMACOVIGILANCE
  • 6:00PM - 7:00PM (GMT Standard Time)

    DRINKS RECEPTION

Day 2 Tuesday, Oct 14, 2014

  • 8:30AM - 10:00AM (GMT Standard Time)

    Topic 2 Session 1: SUSAR REPORTING IN INTERVENTIONAL CLINICAL TRIALS AND CASE STUDIES
  • 10:00AM - 10:30AM (GMT Standard Time)

    COFFEE BREAK
  • 10:30AM - 12:00PM (GMT Standard Time)

    Topic 2 Session 1 continued: SUSAR REPORTING IN INTERVENTIONAL CLINICAL TRIALS AND CASE STUDIES
  • 12:00PM - 1:00PM (GMT Standard Time)

    LUNCH
  • 1:00PM - 1:45PM (GMT Standard Time)

    Topic 2 Session 2: PREPARATION OF DEVELOPMENT SAFETY UPDATE REPORTS (DSURs)
  • 1:45PM - 2:30PM (GMT Standard Time)

    Topic 2 Session 3: PREPARATION OF PERIODIC SAFETY UPDATE REPORTS (PSURs)
  • 2:30PM - 3:15PM (GMT Standard Time)

    Topic 2 Session 4: THE ROLE OF THE QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE
  • 3:15PM - 3:30PM (GMT Standard Time)

    COFFEE BREAK
  • 3:30PM - 5:00PM (GMT Standard Time)

    Topic 2 Session 5: EXPEDITED REPORTING REQUIREMENTS IN THE POST-AUTHORISATION PHASE AND CASE STUDIES
  • 5:00PM - 5:15PM (GMT Standard Time)

    COFFEE BREAK
  • 5:15PM - 6:15PM (GMT Standard Time)

    Topic 2 Session 5 continued: EXPEDITED REPORTING REQUIREMENTS IN THE POST-AUTHORISATION PHASE AND CASE STUDIES

Day 3 Wednesday, Oct 15, 2014

  • 8:30AM - 10:30AM (GMT Standard Time)

    Topic 2 Session 5 continued: EXPEDITED REPORTING REQUIREMENTS IN THE POST-AUTHORISATION PHASE AND CASE STUDIES
  • 10:30AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (GMT Standard Time)

    Topic 2 Session 6: REPORTING REQUIREMENTS IN SPECIAL SITUATIONS IN THE POST-AUTHORISATION PHASE AND CASE STUDIES
  • 12:30PM - 1:30PM (GMT Standard Time)

    LUNCH
  • 1:30PM - 2:30PM (GMT Standard Time)

    Topic 2 Session 7: PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)
  • 2:30PM - 2:45PM (GMT Standard Time)

    COFFEE BREAK
  • 2:45PM - 3:45PM (GMT Standard Time)

    Topic 2 Session 7 continued: PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF)
  • 3:45PM - 4:00PM (GMT Standard Time)

    COFFEE BREAK
  • 4:00PM - 6:00PM (GMT Standard Time)

    Topic 2 Session 7 continued: AUDITS AND INSPECTIONS IN PHARMACOVIGILANCE

Day 4 Thursday, Oct 16, 2014

  • 8:30AM - 9:30AM (GMT Standard Time)

    Topic 3 Session 1: MEDICAL EVALUATION OF ADVERSE DRUG REACTIONS
  • 9:30AM - 10:30AM (GMT Standard Time)

    Topic 3 Session 2: DRUG-INDUCED LIVER INJURY
  • 10:30AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 11:30AM (GMT Standard Time)

    Topic 3 Session 2 continued: DRUG-INDUCED LIVER INJURY
  • 11:30AM - 12:30PM (GMT Standard Time)

    Topic 3 Session 3: QT/QTc PROLONGATION AND THE RISK OF TORSADE DE POINTES
  • 12:30PM - 1:30PM (GMT Standard Time)

    LUNCH
  • 1:30PM - 2:15PM (GMT Standard Time)

    Topic 4 Session 1: MedDRA AND STANDARDISED MedDRA QUERIES (SMQs)
  • 2:15PM - 3:00PM (GMT Standard Time)

    Topic 4 Session 2: INTRODUCTION TO SIGNAL DETECTION
  • 3:00PM - 3:30PM (GMT Standard Time)

    COFFEE BREAK
  • 3:30PM - 4:30PM (GMT Standard Time)

    Topic 4 Session 3: SIGNAL MANAGEMENT IN THE EUROPEAN UNION
  • 4:30PM - 6:00PM (GMT Standard Time)

    Topic 5 Session 1: RISK COMMUNICATION IN EU - CHALLENGES AND POSSIBILITIES

Day 5 Friday, Oct 17, 2014

  • 8:30AM - 9:45AM (GMT Standard Time)

    Topic 5 Session 2: RISK MANAGEMENT COMPONENTS: GENERAL PRINCIPLES
  • 9:45AM - 10:45AM (GMT Standard Time)

    Topic 5 Session 3: RISK MANAGEMENT PLANS: AN INDUSTRY PERSPECTIVE
  • 10:45AM - 11:15AM (GMT Standard Time)

    COFFEE BREAK
  • 11:15AM - 11:45AM (GMT Standard Time)

    Topic 5 Session 4: POST-AUTHORISATION DEVELOPMENT PLAN (PASS/PAES)
  • 11:45AM - 12:45PM (GMT Standard Time)

    Topic 5 Session 5: EFFECTIVENESS OF RISK MINIMISATION MEASURES

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€1631.00
Member Government
€1631.00
Member Standard
€3286.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€1761.00
NonMember Government
€1761.00
NonMember Standard
€3416.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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