HUM-MOLGEN events: Pharmacovigilance: Perspectives and Future Directions

HUM-MOLGEN -> Events -> Meetings and Conferences

Pharmacovigilance: Perspectives and Future Directions

January 17, 2001

SMi, London
21st - 23rd February, 2001

Learn to co-ordinate and communicate pharmacovigilance rapidly and efficiently by attending……
PHARMACOVIGILANCE:
PERSPECTIVES & FUTURE DIRECTIONS
21st & 22nd February 2001, The Hatton, London

A unique opportunity to learn from leading industry experts including:

 Dr Kasia Petchel, Director, European Drug Safety & World-Wide Safety, Pfizer
 Pauline McKenzie, Business Analyst, International Product Safety &
Pharmacovigilance, GlaxoWellcome
 John Freeman, Head, International Clinical Safety - Europe, Amgen
 Kathleen Sullivan, Global Head, Pharmacovigilance Licensing, Roche
 Dr Michele Sangeleer, Pharmacovigilance Manager, Eli Lilly
 Dr Enrico Marchesi, European Safety Manager, Schering-Plough
 Prof Georg Benker, Head, Drug Safety, Merck KGaA
 Prof Ralph Edwards, Medical Advisor, Pharmcovigilance & Centre Director, WHO Uppsala Collaborating Centre for International Drug Monitoring
 Dr Steen Ottosen, Manager, Information Management, Lundbeck
 Lauret Ballsun, Senior Director, Global Safety Surveillance & Product Information, Elan
 Dr Brian Edwards, Senior Director & Head, World-Wide Pharmacovigilance, Parexel
 Graeme Ladds, Head, Global Pharmacovigilance, Shire
 Janet Green, Business Development Manager, Safety Surveillance & Reporting,
Quintiles Ireland
 Vasco Maria, Vice Chairman, Management Board, Infarmed
 Dr Joy Chukwujindu, Head, Pharmacovigilance, Akos
 Dr Bart Teeuw, Director Drug Safety & Quality Assurance, Vigilex
 Bernard Tremaine, Principal Consultant, Regulatory Affairs & QA Consultancy
 Stephen Day, Regulatory Affairs Consultant, PRI Group

Chaired by:

 Joe Irwin, Operations Officer, European Society of Regulatory Affairs (ESRA)
 Dr Munaf Ali, Vice President Regulatory Affairs & Pharmacovigilance, Ingenix

PLUS A HALF DAY INTERACTIVE WORKSHOP
Medical Device Vigilance and Post Market Surveillance
23rd February, a.m.
The Hatton, London

In association with: d-TARGET

Day One – 21st February

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks
Dr Munaf Ali, Vice President Regulatory Affairs & Pharmacovigilance, Ingenix

THE PRINCIPLE GOALS OF PHARMACOVIGILANCE – WHY WE EXIST? AND WHERE WE ARE GOING?
9.10 From the development to the pre- and post-marketing of a drug
 Pharmacovigilance: a historical perspective
 Who are major players in pharmacovigilance?
 Europe
 World
 Why we need dynamic interfaces in pharmacovigilance?
 Tools available to pharmacovigilance
 Spontaneous reporting systems
 Risk-benefit assessment of drug interactions
 Pharmacoepidemiology databases
 Facing the consequences of non-compliance
 Understanding the impact on public health
 Quo vadis pharmacovigilance?
Dr Kasia Petchel, Director, European Drug Safety & World-Wide Safety, Pfizer

EUROPEAN REGULATORY REQUIREMENTS IN A CHANGING CLIMATE
9.40 An update on European drug safety regulations
 What is the European regulatory environment?
 Understanding the regulatory framework in place with a focus on recent changes
 Regulations
 Guidelines
 Directives
 Effect of current changes on existing regulatory guidelines
 Key advantages of implementing national regulations
Stephen Day, Regulatory Affairs Consultant, PRI Group
Dr Lee Evans, Medical Writer, PRI Group

A SPONSOR'S VIEW ON DRUG SAFETY
10.20 Implementing a workable and efficient pharmacovigilance system
 Drug safety databases
 A pharmacovigilance system is more than just a database
 Managing clinical safety data
 Using safety data for regulatory compliance
 Causality assessment by the investigator and by the sponsor
 Using safety data for generating to development core safety information
 Detection of risks that could affect the drug project
 Communication of safety problems within the company
 Problems and possible solutions
Prof Georg Benker, Head, Drug Safety, Merck KGaA

11.00 Morning Coffee

ADR REPORTING IN CLINICAL TRIALS
11.20 Staying ‘one step’ ahead of the regulators
 Regulatory considerations
 Factors that contribute to the array of requirements
 Management of general requirements and associated problems
 Ensuring compliance with expedited and periodic reporting
 Examination and interpretation of events
John Freeman, Head, International Clinical Safety - Europe, Amgen

THE ROLE OF CROs IN PHARMACOVIGILANCE
12.00 Case Study: Akos
 The Need for:
 Premarketing
 Postmarketing
 Medical Information and pharmacovigilance for small and virtual companies
 Coordinating pharmacovigilance activities between MAH and distributors
 European centre for Japanese, Canadian and US Companies
 Pros and cons
 Outsourcing versus cosourcing
Dr Joy Chuwujindu, Head, Pharmacovigilance, Akos

12.40 Networking Lunch

THE CHANGING FACE OF SAFETY MONITORING FOR MARKETED PHARMACEUTICALS
2.00 Case Study: Parexel
 Globalisation: what does it mean and are you ready?
 Outsourcing pharmacovigilance
 Market introduction: how might pharmacovigilance and marketing interact?
 Implications of this interaction for safety studies
 Acceleration of time to market and peak market penetration: implications for pharmacovigilance
 Looking ahead
Dr Brian Edwards, Senior Director & Head, World-Wide Pharmacovigilance, Parexel

PARTNERSHIP, A NEW MODEL FOR SAFETY DATA MANAGEMENT
2.40 Case Studies: Quintiles
 Benefits for Sponsor and CRO
 Case study of a clinical study
 Case study of a marketed product
 Efficiencies gained via partnership
 Metrics and process improvements
Janet Green, Business Development Manager, Safety Surveillance & Reporting,
Quintiles Ireland

3.20 Afternoon Tea

CLINICAL SAFETY DATA MANAGEMENT: OPPORTUNITIES AND PERSPECTIVES
3.40 Periodic safety update reports (PSURs) for marketed drugs
 PSURs: what are they?
 Understanding the timing of the reports
 Three key pieces of the document
 Estimation of patient exposure
 Overall safety evaluation
 Conclusions: what’s new, what’s different and what’s important
 Implementation issues
 Regulatory
 Company
 Future challenges: harmonisation
Dr Enrico Marchesi, European Safety Manager, Schering-Plough

POSTMARKET ISSUES CONCERNING MEDICAL DEVICES
4.20 What are the important issues, how should they be effectively addressed and how can they contribute to the ‘bottom line’?
 Postmarket feedback
 Vigilance reporting
 Product recall and advisory notice issue
 Quality management system links
 Corrective and preventive actions
 Management review
 Iso 9001:2000 implications
 Continuous improvement
Bernard Tremaine, Principal Consultant, Medical Device & QA Consultancy

5.00 Chairman’s Closing Remarks and Close of Day One

5.10 Networking Drinks Reception

Day Two – 22nd February

8.30 Re-registration and Coffee

9.00 Chairman's Opening Remarks
Joe Irwin, Operations Officer, European Society of Regulatory Affairs (ESRA)

IDENTIFICATION AND INVESTIGATION OF SIGNALS: EARLY WARNING MECHANISMS
9.10 A data-mining approach to signal detection and analysis
 ‘Signal’ defined
 Current procedures in signal generation
 How is the threshold for inclusion determined?
 Loopholes in the current system
 Implementation of neural networks by the WHO
 Signal generation using this approach
 External databases used
 New procedures: validating the new systems
Prof Ralph Edwards, Medical Advisor, Pharmcovigilance & Centre Director, WHO Uppsala Collaborating Centre for International Drug Monitoring

PHARMACOVIGILANCE: THE IMPACT OF THE INTERNET
9.40 Harmonising with IT integration: a new reality?
 Recent developments in regulatory software and information management technology
 Can IT revolutionise the ADR process?
 Entering, validating and retrieving data
 Can patient confidentiality be maintained and corporate secrets preserved?
 Risks vs. benefits of using the internet as a backbone
Pauline McKenzie, Business Analyst, International Product Safety &
Pharmacovigilance, GlaxoWellcome

USING ELECTRONIC DATABASES FOR PHARMACOVIGILANCE INFORMATION
10.20 Case Study: Elan
 Choosing the appropriate database that balances searching ability with capacity
 Analysing collated ADRs to establish signals for particular drugs and enhance your detection of drug safety issues
 Using your database to generate electronic reports in the appropriate format for submission to the regulatory authorities
Lauret Ballsun, Senior Director, Global Safety Surveillance & Product Information, Elan

11.00 Morning Coffee

LICENSING ISSUES IN PHARMACOVIGILANCE
11.20 Developing good practices in pharmacovigilance licensing
 Starting with the basics (definitions, regulations, liability)
 Keeping in the corporate licensing loop
 Mapping the process
 Key documentation (SOPs, checklists, the written agreement)
 Challenges in 3rd party negotiations (databases, literature, coding practices)
 Keeping people informed
 Compliance (performance metrics, tracking systems, feedback)
Kathleen Sullivan, Global Head, Pharmacovigilance Licensing, Roche

DRUGS AND ADVERSE EVENTS: ASSOCIATION OR CAUSATION?
12.00 Assessing causality in safety issues
 Why causality assessment is important
 When to assess causality
 What is the role of imputation systems
 Global introspection
 Algorythms and decision trees
 Bayesian models
 Causality attribution and common sense
 Case study: drug-induced hepatitis
Vasco Maria, Vice Chairman, Management Board, Infarmed

12.40 Networking Lunch

REPORTING OF ADVERSE DRUG REACTIONS FROM CLINICAL TRIALS
2.00 Case Study: Shire
 Regulatory requirements: deciding which reports to submit
 Requirements for new products in clinical trials
 Practical problems that may be encountered
 Work together with investigators to report serious adverse events
 Interpretation of events
Graeme Ladds, Head, Global Pharmacovigilance, Shire

PHARMACOEPIDEMIOLOGY STUDIES
2.40 The powers and perils of pharmacoepidemiology research in the 21st century
 What is the purpose of these studies and when should you conduct one?
 Identifying data sources of interest
 Getting grips with a plethora of study methodologies
 The potential to anticipate ADRs?
 Limitations of these studies
Dr Bart Teeuw, Director Drug Safety & Quality Assurance, Vigilex

3.20 Afternoon Tea

LABELLING ISSUES IN PHARMACOVIGILANCE
3.40 Understanding the core data sheet concept for world-wide labelling harmonisation
 Core data sheets for new drugs: impact on harmonisation
 Format and content of a core data sheet
 Systems and processes to achieve global alignment
 Striving for harmonisation: ensuring meticulous documentation
 Worst case scenarios: what can happen if labelling and harmonisation are not met
Dr Michele Sangeleer, Pharmacovigilance Manager, Eli Lilly

PHARMACOVIGILANCE, A VISION FOR THE FUTURE
4.20 Looking ahead: where do we go from here?
 Science and epidemiology in pharmacovigilance
 Electronic communication and standardisation
 Expedited reporting and other means of data collection
 Global utilisation of pharmacovigilance data
 Cooperation of Industry, public research and authorities
Dr Steen Ottosen, Manager, Information Management, Lundbeck

5.00 Chairman's Closing Remarks and Close of Conference
Workshop:

Medical Device Vigilance and Post Market Surveillance
23rd February 2001, a.m., The Hatton, London

Whilst regulation regarding medical devices constantly develops, medical device manufacturers face an expanding number of standards, testing practices and government regulations world-wide – Are you ready? These developments require continued vigilance in tagging standards, testing requirements and regulations in whatever markets medical device manufacturers do business. This interactive forum provides an extensive overview of the activities and initiatives undertaken in medical device vigilance. Our established workshop leader will also advise you on how to implement and maintain essential reporting and tracking strategies.

8.30 Registration and Coffee

9.00 The regulations
 EU regulations
 National interpretations & obligations
 Vigilance reporting during clinical investigations

10.00 Implementation strategies
 PMS
 Vigilance reporting procedures
 Vigilance tracking mechanisms

11.00 Morning Coffee

11.30 Future trends
 What are regulators setting up?
 How to get the information
 Analysing the data

12.00 Discussions

12.30 Close of Workshop

Danielle Giroud started her career in the Medical Device industry in 1987 as a product manager for vascular stents for Schneider, Europe. In 1991, she joined Ares Serono's Infertility Treatment Team managing corporate trials worldwide. From 1993, to 1997 as Director Clinical Affairs, she was responsible for successful development and implementation of the worldwide clinical program at Collagen Int. Her business background guarantees efficient and cost-effective project management and strategic planning. Since 1997, Mrs Giroud RN-MBA has been the president and founder of d-TARGET.

d-TARGET is a European based service organisation providing worldwide regulatory, clinical research and Quality Assurance services for medical devices and In-Vitro diagnostic products manufacturers. Our goal is to provide Quality expertise combined with practical guidance taking into account our customers’ overall business strategy.

d-TARGET has expertise in:

Regulatory strategic planning - Global US and European EC directives compliance, CE marking, Notified bodies liaison and Competent Authorities notification, Post-marketing surveillance and Vigilance programs;

Clinical research - Strategy setup, design, protocol writing, center selection and monitoring, data processing, GCP training and auditing ;

Quality Assurance - ISO 9000, EN 46000, QSR implementation, Audits and training.

PHARMACOVIGILANCE:
PERSPECTIVES & FUTURE DIRECTIONS
21st & 22nd February 2001, The Hatton, London

Dear Pharmaceutical Executive,

“ Pharmacovigilance is more than just drug surveillance – it’s a multidisciplinary activity covering the diagnosis, prevention and treatment of adverse drug reactions, research into the causes, mechanisms of side-effects, the regulatory aspects and general safety of drugs.”
Prof Rene-Jean Royer, President of the European Society of Pharmacovigilance

It is only recently that pharmacovigilance has received the prominence that it deserves as a result of ADR reporting coming under close scrutiny over the past few years. It has been recognised that ADRs may be responsible for more than 100,000 US deaths nation-wide each year - making it one of the leading causes of death (Lazarou et al., 1998). Incredibly, it is now believed that ADRs are ranked fourth leading cause of death behind heart disease, cancer and strokes.

With this knowledge in mind, our challenge at SMi was to assemble key industry peers from across the pharmaceutical spectrum that would provide pertinent and up-to-date information on pharmacovigilance – an arena that remains in constant flux. As you can see from this brochure we have achieved our goal.

Why should you attend this event?
This is your opportunity to meet senior industry and government figures and seek their advice and opinions. This comprehensive conference will embrace the most important issues within pharmacovigilance today including signal detection, causality analysis, PSURs, IT integration and licensing issues. Moreover, top industry specialists will discuss their personal experiences by revealing best practice case studies from their respective companies.

PLUS A HALF DAY INTERACTIVE WORKSHOP
Medical Device Vigilance and Post Market Surveillance
23rd February, a.m.
The Hatton, London

To learn how to co-ordinate and communicate pharmacovigilance rapidly and efficiently, register now using the booking form on the back of the brochure or visit www.smi-online.co.uk/pharmaco.asp to register online.

I look forward to seeing you in London in February.

Yours faithfully,
Susie Palmer Ph.D.
Associate Conference Producer
Tel: +44 (0)20 7827 6042
Email: spalmer@smi-online.co.u

Organized by:

SMi

Invited Speakers:

Confirmed Speakers:

 Dr Kasia Petchel, Director, European Drug Safety & World-Wide Safety, Pfizer
 Pauline McKenzie, Business Analyst, International Product Safety &
Pharmacovigilance, GlaxoWellcome
 John Freeman, Head, International Clinical Safety - Europe, Amgen
 Kathleen Sullivan, Global Head, Pharmacovigilance Licensing, Roche
 Dr Michele Sangeleer, Pharmacovigilance Manager, Eli Lilly
 Dr Enrico Marchesi, European Safety Manager, Schering-Plough
 Prof Georg Benker, Head, Drug Safety, Merck KGaA
 Prof Ralph Edwards, Medical Advisor, Pharmcovigilance & Centre Director, WHO Uppsala Collaborating Centre for International Drug Monitoring
 Dr Steen Ottosen, Manager, Information Management, Lundbeck
 Lauret Ballsun, Senior Director, Global Safety Surveillance & Product Information, Elan
 Dr Brian Edwards, Senior Director & Head, World-Wide Pharmacovigilance, Parexel
 Graeme Ladds, Head, Global Pharmacovigilance, Shire
 Janet Green, Business Development Manager, Safety Surveillance & Reporting,
Quintiles Ireland
 Vasco Maria, Vice Chairman, Management Board, Infarmed
 Dr Joy Chukwujindu, Head, Pharmacovigilance, Akos
 Dr Bart Teeuw, Director Drug Safety & Quality Assurance, Vigilex
 Bernard Tremaine, Principal Consultant, Regulatory Affairs & QA Consultancy
 Stephen Day, Regulatory Affairs Consultant, PRI Group

Chaired by:

 Joe Irwin, Operations Officer, European Society of Regulatory Affairs (ESRA)
 Dr Munaf Ali, Vice President Regulatory Affairs & Pharmacovigilance, Ingenix

Deadline for Abstracts:

all slots now taken

Registration:

by internet www.smi-online.co.uk/pharmaco.asp

E-mail:

spalmer@smi-online.co.uk

Posted by:

Dr Susie Palmer

Host:

213.38.112.46