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

Stephen Heaton
Head of Safety Risk Management Planning and Coordination, Global Pharmacovigilance
Bayer Schering Pharma

Effective Risk Management And Pharmacovigilance Strategies

09:10 Strengthening Pharmacovigilance To Monitor Adverse Effects Of Medicines

• Providing clear roles, responsibilities and obligations for the key responsible parties
• Strengthening transparency and communication on safety issues to increase the understanding and trust of patients and health professionals
• Improving pharmacovigilance systems while maintaining efficient use of resources
• Enabling easier monitoring of adverse reaction and strengthening the reporting system
• Ensuring the proactive collection of high quality safety data through risk management and co-ordinated data collection
• Strengthening and implementing existing pharmacovigilance and drug safety programmes

Ennis Lee
Vice President, QPPV Pharma
Johnson and Johnson

09:50 Developing Globally Effective Pharmacovigilance Strategies

• Understanding current legislation and new developments including the FDA’s Risk Evaluation and Mitigation Strategies (REMS)
• Integrating RMPs to develop a standardised drug safety strategy
• Harmonisation across key markets
• Integrating pharmacovigilance into the broader healthcare strategy

Enrica Alteri
Head Risk Management & Epidemiology, Global Drug Safety
Merck Serono

Developing Robust And Comprehensive Risk Management Plans

11:00 Implementation And Evaluation Of Risk Management Plans

• How to arrive at an appropriate safety specification
• Developing a methodology for drug safety and risk minimisation that can be applied across a range of products
• Guidance on the template and the format for the presentation of data
• Measuring effectiveness and methodologies for monitoring RMPs
• Reviewing PV action plans to ensure regulatory compliance
• Evaluating RMPs to maximise the efficiency of drug safety strategies
• Proactive development of RMPs through observation of the practical implementation to identify improvements

Stephen Heaton
Head of Safety Risk Management Planning and Co-ordination, Global Pharmacovigilance
Bayer Schering Pharma

11:40 How Small Companies Can Achieve Compliance With The EU Risk Management Requirements

• Discrepancy between limited data for niche products
• Information required for the EU RMP template
• Lack of statistical options to identify patients at risk for particular ADRs
• Lack of resources to generate required epidemiological data
• Case study: in which circumstances can an abbreviated RMP be acceptable for the EMEA?

Hans Joachim Gamperl
VP Global Drug Safety and Pharmacovigilance QPPV
Fresenius Biotech

Pharmacovigilance Processess Across Emerging Markets

13:30 Current Challenges And Future Developments For Drug Safety In Emerging Markets

• The local regulatory environment and expectations of competent authorities
• Developing Risk Management Plans to conform to different regulatory standards
• Challenges for the global PV systems
• Identifying commonalities across the emerging markets for a more standardised approach to risk management

Dr. Monica Rusu
Director Pharmacovigilance EELA
Abbott Products GmbH

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: Effective Implementation Methods for RMPs

This discussion focuses on implementing your RMPs strategies and choosing the right tools to gather data

Stephen Heaton
Head of Safety Risk Management Planning and Co-ordination, Global Pharmacovigilance
Bayer Schering Pharma

Roundtable B: Managing Pressure from the Public and Other Outside Agencies in Drug Safety Matters

This discussion focuses on communicating the risk/benefit balance to the public and managing pharmacovigilance programmes to reduce the incidence of adverse events

Enrica Alteri
Head Risk Management & Epidemiology, Global Drug Safety
Merck Serono

Roundtable C: Maximising Drug Safety Through Consistent Application of PV Measures

This discussion focuses on the different global PV legislation and strategies to develop a consistent, harmonised approach to PV

Dr. Monica Rusu
Director Pharmacovigilance EELA
Abbott Products GmbH

15.45 Case Study - Drug Safety In Early Phase Oncology Trials

• Early phase oncology trials in patients
• Underlying illness vs disease progression vs safety signals
• Interactions in heavily medicated patients
• IMP quality issues with an impact on safety
• Regulatory tools and meeting expectations

Catarina Macedo
Pharmacovigilance Manager
Cancer Research UK

Keeping Up With New Regulatory Challenges

16:25 Integrating A Safety Risk Management Strategy Into Pharmacovigilance Plans

• Identifying what makes an effective Risk Management Plan
• Safety management of well established and new products
• Effective methods for risk mitigation to meet regulatory expectations
• Lessons learned from the practical implementation of RMPs to determine best practice

Petra Heyen
VP Regulatory Affairs and PV
Therabel Pharma

Successful Signal Detection Practices For Large And Small Databases

17:05 Signal Detection Strategies At Genzyme To Support Pharmacovigilance And Risk Management Approaches

• Structures and systems to support qualitative signal detection
• Optimal safety signal detection in large and small databases
• Balancing quantitative and qualitative signal detection
• Validating safety signal assessment by medical professionals

Erica Velthuis
Senior Pharmacovigilance Scientist
Genzyme

17:45 How To Work Statistical Signal Detection Into Routine Practice

• Improving the process of signal detection and signal management by introducing semi-automated system
• Implementing advanced statistical analyses of internal company database
• Testing the suitability of a company (smaller) database for statistical analysis
• Validating the suitability of regulatory statistical analysis threshold for use with a company database

David Turner
Patient Safety Scientist
AstraZeneca