Research and Markets Adds Report: ‘Pharmacovigilance – A Basic Training Course for Those Working on Drug Safety Monitoring in the EU, USA and Japan…

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Research and Markets Adds Report: 'Pharmacovigilance - A Basic Training Course for Those Working on Drug Safety Monitoring in the EU, USA and Japan (Conference, London)'

Research and Markets has announced the addition of the "Pharmacovigilance - A Basic Training Course for Those Working on Drug Safety Monitoring in the EU, USA and Japan (Conference, London)" conference to its offerings.

In a release, Research and Markets noted that report highlights include:

The Pharmacovigilance Conference will take place on the 09-11 Jun 2014 at The Rembrandt Hotel, London

WHY YOU SHOULD ATTEND

This Management Forum course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.

WHO SHOULD ATTEND

This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.

KEY TOPICS TO BE ADDRESSED AT THIS CONFERENCE:

-Principles of Pharmacovigilance and Data Resources

-Risk Management and the development of the Pharmacovigilance plan

-Causality Assessment: Clinical Diagnosis of Adverse Events

-Pharmacoepidemiology Studies

-Evolution of PSURs, PBRERs and DSURs

-Pro-active Pharmacovigilance Pre- and Post Marketing

-Pharmacovigilance Regulations (clinical trials & post marketing) including new EU Pharmacovigilance

-Risk/Benefit Analysis

-Drug Surveillance in countries outside Europe

-Post-marketing Surveillance: Observational Cohort Studios

-Introduction to Signal detection

-Introduction to Risk Management plans

-Practical Pharmacovigilance Workshop

Key Topics Covered:

Day One

CHAIRMAN: PROF. SAAD SHAKIR

09.30 - Principles of Pharmacovigilance and Data Resources

-Basic principles of monitoring drug safety

-An overview of methodology

-Data resources available for monitoring and evaluating drug safety

-Responding to drug safety signals

Professor Saad Shakir

10.30 - Coffee

10.45 - Risk Management and Risk Minimisation: Basic Principles

-Basic principles

-Proactive strategies

-Development of the pharmacovigilance plan

Professor Saad Shakir

11.30 - Causality Assessment: Clinical Diagnosis of Adverse Events

-The principles of causality assessment with practical examples

-Medical evaluation of individual reports of adverse events

-Strategies for follow up

Professor Saad Shakir

12.30 - Discussion

12.45 - Lunch

CHAIRMAN: SHELLEY GANDHI

14.00 - Regulatory Framework

-Overview of European regulatory framework, including new EU pharmacovigilance legislation

-Implications for global environment - the links to ICH and CIOMs recommendations

-Inspections and penalties for non-compliance

-Practical applications of definitions

Shelley Gandhi

15.30 - Tea

15.45 - European Post-Marketing

-Pharmacovigilance Regulations

Overview of requirements which will include:

-The role of Pharmacovigilance Risk Assessment Committee

-Quality Management Systems and the Pharmacovigilance Master File (PSMF)

-QPPV

-Expedited Reporting solicited vs spontaneous

-Periodic reports and Signal Management

-Risk Management Plans and Risk Minimisation

-Post Authorisation Safety and Efficacy studies (PASS/PAES)

-Additional Monitoring

-Pharmacovigilance Inspections

Shelley Gandhi

17.15 - End of Day One and Drinks

Reception

Day Two

10 June 2014

CHAIRMAN: DR JOHN TALBOT

09.00 - Pro-active Pharmacovigilance

-Pre- and Post Marketing

-Anticipating drug safety issues in development of small molecules and biologics

-What specific and non-specific safety monitoring should be done?

-Handling safety signals in development

-Differences between pre-marketing studies and post-marketing experience

Dr John Talbot

10.00 - Discussion

10.10 - Risk/Benefit Analysis

-Standardising risk/benefit analysis

-Putting risks into context

-Taking effective action and communicating effectively

Inga Bellahn, PhD

11.10 - Discussion

11.15 - Coffee

11.30 - Clinical Trial ADR Reporting Requirements

-ICH E2A and General requirements

-Expedited reports

-EU Clinical Trials Directive and Detailed guidance (CT-3)

-US IND Requirements

-Development Safety Update Reports (DSURs)

Dr John Talbot

12.35 - Discussion

12.45 - Lunch

CHAIRMAN: DR JOHN PARKINSON

14.00 - Pharmacoepidemiological Studies -

-Basic Designs, Strengths,

-Weaknesses and Examples

-Real World Data is the King

-Randomisation in the real world

-Drugs and devices- its all exposure

-Tracking all Patients?

Dr John Parkinson

15.30 - Tea

15.45 - Where are we now with PSURs (or PBRERs)?

-Evolution of the PSUR, PBRER and DSUR

-ICH E2C, Volume 9A, GVP Module VII and ICH E2C (R2)

-What do we submit now and when is it required?

-Practical aspects of compiling PSURs

-The link between DSURs, RMPs, PSURs, and Core Safety Information

Carol Markwell

16.45 - Discussion

17.00 - End of Day Two

Day Three

CHAIRMAN: DR GLYN BELCHER

09.00 - Drug Surveillance in Countries Outside Europe

-US culture

-NDA and IND safety reporting

-Inspections

-Japan culture

-Post-marketing safety surveillance programmes in Japan

-Pharmacovigilance in developing countries

Dr Glyn Belcher

10.00 - Discussion

10.15 - Post-marketing Surveillance: Observational Cohort Studies

-Monitoring events v monitoring ADRs

-Using observational cohorts for signal detection v signal clarification

-Strengths and pitfalls of observational studies

Dr Lynda Wilton

11.00 - Coffee

11.20 - Introduction to Signal Detection

-Definitions of signals

-Regulatory guidances on signal detection by industry and regulators

-Resources for signal detection

-Quantitative v qualitative signal detection

Dr Glyn Belcher

12.00 - Introduction to Risk Management Plans from the Industry Point of View

-The details of the EU risk management plan and how successfully to write one

-Assessment of risk management plans by EU regulators

-Updating risk management plans and the link with the new PSUR Global risk management plans

-What to consider concerning operationalisation of risk management plans

-A real world case example of the development of an EU risk management plan

Dr Glyn Belcher

13.00 - Discussion

13.15 - Lunch

14.15 - Practical Pharmacovigilance Workshop

As requested by previous participants in this course, this session will comprise a practical case study with valuable hands-on experience covering:

-Handling an important safety alert from regulators

-Assessment of risk

-Determining measures to respond to previously unidentified risks

-Continuing assessment and communication of risk benefit

Dr Lynda Wilton & Dr Glyn Belcher

16.00 - End of conference and Tea

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