09:00Pharma IQ Welcome And Chairperson’s Opening Address

Philippe Van der Auwera
Global Head of Safety Risk Management and EU-QPPV
Roche

The Regulatory Landscape In Drug Safety

09:10Regulator: Pharmacovigilance And Risk Management In 2010: A Contemporary Strategic Approach

Regulator

• Current trends with impact on the development of pharmacovigilance
• Major elements of a national action plan
• Establishing co-operation and communication with regulatory bodies

Doris Stenver
Chief Medical Officer, Consumer Safety Division
Danish Medicines Agency

09:50Regulator: National Regulatory Case Study - Iceland: Improving Drug Safety Through Better Communication With Patients

Regulator

• Adverse events reporting in a small population
• Promoting adverse events reports from healthcare staff and the public
• Adverse events reports from the public: our experience to date

Rannveig Gunnarsdóttir
Executive Director
Icelandic Medicines Control Agency

Pharmacovigilance Inspections And Compliance

11:00 Co-Ordination And Evaluation Of Audits And Inspections

• Preparing for the challenge of risk based inspections
• Ensuring that your processes are in line with peers and current expectations
• Using resources effectively during the inspections process
• Compiling an inspection readiness plan in order to address key regulatory risks

Vicki Edwards
Senior Director, European Pharmacovigilance
Abbott

Achieving Transparent Risk Management Through Public Communication

11:40 Communicating Benefits And Risks To Patients And Prescribers: Are We Using The Right Tools?

• Understanding that transparency is not communication
• Google vs. health authority websites vs. company websites
• More paper with small printing? More DHPL?
• Understanding constraints in prescribing medication: are doctors going to spend more than 10 minutes discussing a proposed treatment?
• How to escape the paternalistic model
• How to get out of the lose/lose situation for health authorities and the pharmaceutical industry

Philippe Van der Auwera
Global Head of Safety Risk Management and EU-QPPV
Roche

Interaction Of The QPPV With The Regulators

13:30 Effective Communication Between The EU QPPV And Local Affiliates

• Ensuring adequate knowledge of the pharmacovigilance system including ICSRs, PSURs, PASS, safety profile of products, audits, SOPs and databases
• Putting in place an inspection readiness plan for all affiliates to ease the burden while increasing compliance of regulatory inspections
• Communication between the central PV team and the affiliates to develop a robust company-wide drug safety policy

Ute Hoeffner
EU Qualified Person for Pharmacovigilance
Novartis Consumer Health

14:10 Break-Out Round Table Discussions: Participants Will Be Able To Choose Between The Different Roundtables And Spend 45 Minutes Discussing The Points Outlined Below Before Feeding Back To The Group

Roundtable A: Establishing Clear and Co-ordinated Communication Channels on Safety Risk Issues

This discussion focuses on communicating key information and a summary of product characteristics to physicians and patients to ensure a clear understanding of the risks and benefits of treatments

Philippe Van der Auwera
Global Head of Safety Risk Management and EU-QPPV
Roche

Roundtable B: The Role of the EU Qualified Person for Pharmacovigilance

This discussion focuses on the role of the QPPV in managing the implementation of the overall PV plan and how to manage risk within the requirements of the role

Peter De Veene
Deputy European Qualified Person for Pharmacovigilance
Roche

Roundtable C: Being Prepared for and Managing the Inspections Process

This discussion focuses on challenges and key tasks in preparing for inspections by national regulators and how to ensure a sustained state of readiness at all times

14:55 Roundtable Facilitators’ Feedback To The Entire Delegation

World Health Organisation Risk Assessment Overview

15:45 Benefit-Risk Assessments: The Role Of Quantitative Approaches Today And Tomorrow

• Understanding the need for better approaches to assessing benefit and risk of medicinal products
• Overview of recently proposed methods and new developments
• Possible implications for industry

Ola Caster
Drug Safety Analyst
Uppsala Monitoring Centre

Managing The Roles And Responsibilities Of The Qualified Person For Pharmacovigilance

16:25 Providing Support For Pharmacovigilance Qualified Persons And Responsible Person For EudraVigilance

• Keeping up with challenging new regulations to ensure compliance
• The legal obligations of being a QPPV
• Clarifying the level of appropriate training for qualified and responsible persons
• Managing the challenges and problems of ensuring organisation-wide pharmacovigilance

Peter De Veene
Deputy European Qualified Person for Pharmacovigilance
Roche

The Role Of Post Authorisation Safety Studies In Your Risk Management Plan

17:05 Maximising The Utility Of Observational Post-Authorisation Safety Studies (PASS)

• The who, how and where of observational PASS: getting it right to comply with regulatory requirements
• Using PASS as a tool to further characterise risks as part of your RMP
• Developing appropriate study designs and making the best use of resources
• Using PASS to evaluate potential signals
• Looking at ‘real-world’ data to fill in missing information including off-label use and overdoses

Daniel O. Koralek, PhD Associate Director, Epidemiology
Worldwide Safety Strategy
Pfzier