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EMA Excellence in Pharmacovigilance: Clinical trials and post-marketing

Feb 17 2014 8:00AM - Feb 21 2014 3:30PM | European Medicines Agency Canary Wharf, 7 Westferry Circus London E14 4HB United Kingdom

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Overview 

This course has reached its maximum capacity.
Please register for the next occurance in October.

This course is designed to provide a firm grounding in key aspects of Global Clinical Pre- and Post-Marketing Safety. 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 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 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 35 credits.

Who Should Attend 

Intermediate Level

Professionals involved in pharmacovigilance, clinical research, regulatory affairs, risk management, medical product safety assessment, and data analysis, epidemiology, labelling, quality assurance, compliance, medical information.

Learning Objectives 

For the five key topics as outlined below, the learning objectives now 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 topics and the ISO Individual Case Safety Report (ICSR) and Identification of Medicinal Products (IDMP) standards

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

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 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
  • Explain and illustrate methods used in pharmacoepidemiology for measuring risks and estimating their association with drug exposure
  • 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 

The training course takes place at the:
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom


DIA has blocked a limited number of rooms at the following hotel:

Hilton London Docklands Riverside
265 Rotherhithe Street
SE16 5HW London
United Kingdom

Tel.: +44 207 231 1001
Fax: +44 207 231 0599
Email: reservations.docklands@hilton.com
Website: www.hilton.co.uk/docklands

at the rate of:
GBP 139.00 per single room and GBP 149.00 per double room inclusive of breakfast and VAT.
To make your reservation, please use the following link:
http://www.hilton.com/en/hi/groups/personalized/L/LONNDHI-GDIAB-20140216/index.jhtml?WT.mc_id=POG

If cancellation occurs within 7 days of arrival, a 100% cancellation charge of one night stay will apply.
Important: The room rate is available until 6 January 2014 or until the group block is sold-out, whichever comes first.

Contact Information 

DIA Europe
Kuechengasse 16
4051 BASEL
SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org

Faculty 

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Registration Fees 

Member

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

Non-Member

Charitable Nonprofit/Academia Nonmember
€1746.00
NonMember Government
€1746.00
NonMember Standard
€3401.00
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