Reasons to Register:

• Discuss key elements of the medical evaluation of adverse events
• Evaluate methods for quantitative benefit-risk analysis and discuss their practical application in decision making
• Enable yourself to make the right decisions relating to regulation
• Understand the main characteristics of drug induced adverse events
• Rapidly detect drug risks as well as defend the product against an inappropriate removal
• Examine barriers to cost reduction in drug discovery and development
• Recognise the important aspects in evaluating adverse events based on the main system organ classes
• Find out which are likely to be the most profitable business models for high-patent throughput
• Learn what can be done to drive up revenues through outsourcing studies
• Cope with the increase in volume of data

WORKSHOP (11th June 2008)

There will be a Pre- conference Workshop on the 11th June 2008 which will be led by Mr. Richard Thomas, Regulatory Compliance Services & Solutions Manager, CTG (UK).

Key topics covered at the workshop include:

• Management of Adverse Event data workflows
• Validation and control of pharmacovigilance computer systems
• What do the Regulators look for?
• The challenges of maintaining data integrity

DAY 1 (12th September 2008)

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Anthony R. Cox

Teaching Fellow (Pharmacy Practice), Aston University
Senior Pharmacovigilance Pharmacist, West Midlands Centre
for Adverse Drug Reaction Reporting

INTEGRATING RISK MANAGEMENT STRATEGIES
INTO PHARMACOVIGILANCE PLANS

09:40 Interpreting the benefit/risk ratio and how to
guarantee you find the correct balance?

• Exploring the relationship between Pharmacovigilance and Risk Management
• Practical examples
• Determine the necessary actions to improve a product’s safe use
• Measuring ROI and profitability

William Gregory
Director, Safety and Risk Management
Pfizer

10:20 Challenges of monitoring patient safety in early
clinical trials

• Examples of safety monitoring challenges
• Recent changes to regulatory requirements and guidance
• Defining risk management strategies for early clinical trials

Angela Wardman
Patient Safety Scientist, Surveillance section, UK Patient Safety
Astrazeneca

11:10 Morning refreshments

11:30 Panel Discussion: Getting the best from
collaborative working

• Proactive pharmacovigilance throughout the product lifecycle
• Transferring the pharmacovigilance advancements of the West to
developing nations
• Changing the mind set of people working in regulatory agencies and
international pharmaceutical companies
• Strategies and proposals to build, maintain and implement a robust
pharmacovigilance system for various stakeholders
• Licensing partners and pharmacovigilance

DEALING WITH ELECTRONIC REPORTING

12:10 Evaluating clinical signals and their relevance to
pharmacovigilance
• Overcoming suspected unexpected serious adverse reactions in a timely manner
• Codify and standardize the act of signal detection and risk management
in the context of clinical trials
• Moving beyond current limitations

Georg Ferber
Group Head, Biostatistics
Novartis

12:50 Networking luncheon

14:00 Use of anonymised clinical data to make proper
assessment of risk benefit

• How to minimise risk and maximise benefit
• Modelling clinical trial data and real-world data
• Using data from Europe and the USA

John Parkinson
Group Head
General Practice Research Database Group, MHRA

14:40 Pharmacovigilance inspections, observations of
changes the second time round

• Observations on a recent inspection in 2007
• How have things changed since 2004?
• Lessons learned and ways forward

Phillip Berry
Global Medical Director
Reckitt Benckiser

15:20 Afternoon refreshments

PHARMACOVIGILANCE AND CLINICAL TRIALS

15:40 Why do people report adverse reactions?

• Characteristics of reporters and non-reporters
• What puts them off, and what encourages them?
• How can the industry encourage ADR reporting?
• How do you optimise the capture of follow-up information?

Anthony R. Cox
Teaching Fellow (Pharmacy Practice), Aston University
Senior Pharmacovigilance Pharmacist, West Midlands Centre
for Adverse Drug Reaction Reporting

16:20 Minimising the risk when moving from clinical trials
to a real patient scenario

• Do cohort studies always require relatively large population samples?
• Can prospective studies require prolonged periods of follow up?
• Exploiting conventional weaknesses

Massimo Raineri
Head of System Development
Actelion

17:00 Chairperson’s closing remarks

17:10 Networking Drinks Reception

Take your discussions further and build new relationships in
a relaxed and informal setting.

DAY 2 (13th June 2008)

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Anthony R. Cox
Teaching Fellow (Pharmacy Practice), Aston University
Senior Pharmacovigilance Pharmacist, West Midlands Centre
for Adverse Drug Reaction Reporting

REGULATORY ENVIRONMENTS IN THE EU AND USA

09:40 Assessing the roles and responsibilities of the
pharmacovigilance Qualified Person

• Monitoring and the sponsor’s audit
• Monitoring the impact of action taken
• Increasing patient convenience and reducing costs through outpatient services
• Company department links to pharmacovigilance

Gurdyal Kalsi
Global Head, Medical and Regulatory Affairs, Global Clinical Development
MDS Pharma services

10:20 Volume 9A of the Rules Governing Medicinal
Products in the EU

• Increase patient volume, improve outcomes, and boost revenue
• Improving public health and safety
• Overcoming increased competition and rapidly changing frameworks
• Will the changes promote international harmonisation?
• Are further amendments needed to European Union Directive
2001/83/EC?

Caroline Bollars
EU Policy Manager
EPHA

11:00 Morning refreshments

11:20 Overcoming the increase in drug safety concerns

• How to identify changes in the patterns of adverse effects
• Enterprise requirements
• How important is promoting understanding, education and clinical training?
• A look to the future

Representative
IMS Health

12:00 In vivo and in vitro approaches to reduce failures of
NCEs due to unexpected toxicities

• The role of a safety assessment liaison at an early stage in drug discovery
• In vivo studies that provide diagnostic biomarkers to guide mechanistic in
vitro studies
• The drug discovery funnel: examples when early toxicity studies inform
decision making
• In vivo and in vitro technologies that will be used to improve the quality
of compounds emerging from the drug discovery stage in pharmaceutics

Kevin Leach
Toxicology Chair-Elect
Merck

12:40 Networking luncheon

THE BENEFITS OF POST-MARKETING STUDIES

13:50 Risk management: a new paradigm for
pharmacovigilance

• Transversal aspect of risk management
• Minimisation/prevention action plans: case study
• Risk communication: Interface between pharmacovigilance and
sales and marketing

Dr Irene Fermont
Risk Management, Pharmacovigilance and EUQPPV
Consultant, Member of the European Association of QPPV

14:30 Risk management versus market withdrawal

• Public scrutiny of medicines and the impact of recent withdrawals
• Do risk management plans effectively manage risk?
• Understanding how new safety data influence decisions
• Guiding principles for the future

David J Lewis
Head of IMS PVO
Novartis

15:10 Afternoon refreshments

15:30 Assessing the benefits of epidemiological studies in
identifying early safety issues

• Ischemia imaging and plaque imaging in diabetes
• Making a contribution to the assessment of benefit, harm, effectiveness
and risk of medicines
• Complementary tools to improve cardiovascular risk management
• Detecting pancreatic inflammation in type 1 diabetes and its reversal in
animal models

William Maier MPH PHD
Senior Director, Epidemiology
Elan

16:10 Panel Discussion – Encouraging safe, rational
and more effective drug use

• How can enterprises integrate with business processes
and applications?
• Pharmaceutical target validation
• Current case studies

The panel will be joined by key speakers from both days