Safety practitioners are great at rousing each other to the clarion call of product defence, but are we actively nurturing links with all the right partners? Speakers and attendees at the eyeforpharma conference on Drug Safety for Marketed Drugs, held in Amsterdam on 22-23 November 2005, encompassed a broad mix, ranging from epidemiology, clinical development, pharmacovigilance, data management, clinical research organisations, health authority, information technology (IT) and management, including some involved in marketing. This mix reflects the interdisciplinary field of drug safety surveillance. However, the telling gap was the lack of a significant sales and marketing presence, which, considering the recent concerns over marketing ‘spin’ for licensed drugs, shows how this can influence and potentially damage the prospects of otherwise useful pharmaceutical preparations. Perhaps there are opportunities here to have a more holistic conference that challenges both the safety and marketing of drugs internationally. Drug safety and marketing are often seen as incompatible partners in drug companies, and are roles that are seen as directly combative. This should not be the case, and one hopes the recent moves by the UK Medicines and Healthcare Products Regulatory Agency to monitor and challenge drug company marketing will address this.
This ‘them and us’ position is well established. Marketing colleagues are the face of industry, interacting with the user community on a daily basis. Their primary focus may be on pitching treatment benefits, but gradually there is grudging acceptance that product safety is becoming a pressing issue for retaining market presence. The sea change apparent among company representatives actively co-operating with meeting adverse event reporting obligations would support this notion. Nevertheless, increased dialogue needs to be cultivated between safety and marketing, with the latter permitting more visibility for safety in the fi eld and the former being less introspective. Perhaps the answer is to train the marketers in drug safety as part of an industry-wide move to address this issue?
Safety surveillance is strategic for product health and should not be seen as the harbinger of bad news. Clearly, marketing will continue to act as the corporate face of the industry. However, such communications can only be enhanced through closer interactions with safety colleagues who are fully equipped with updated information on the risk/benefit balance of products. In the paraphrased words of one speaker, Cinderella is fast becoming a princess; perhaps so, but only with Prince Charming motivated to sweep her out of obscurity into the limelight right by his side.
CONTENTS
Drug Safety for Marketed Drugs - programme
Introduction
About the editor
Communicating value and the value of communication
The importance of real-world data
Are you truly aligned with regulatory expectations?
German pharmacovigilance: legal basis
Electronic transmission of information within the EC
Using technology to gather and communicate safety data
The place of registries in product surveillance
The cipher code
Benefits of electronic data capture
Enhancing drug safety knowledge management
Conclusion
References
ABOUT THE EDITOR
Martin Fagan is a Senior Executive Director with over 25 years experience in the healthcare, pharmaceutical, NHS (public sector) and data/IT/CRM industries, both in the UK and internationally. He has experience in start-up, rescue, organisational restructure, spin out and sales/marketing/business development in the pharmaceutical, B2B and IT industries, as well as in NHS supply. He also has extensive experience of commercial databases and patient data in clinical research, and knowledge of NPfIT and current NHS changes and opportunities through his current role as Vice President Market Insight Solutions for Infonetica.
Martin qualified as a toxicologist and, after a brief spell in research, progressed through the commercial arm in the pharmaceutical and supplies industries, including 4 years in Asia responsible for trade with over 10 countries. He established his own consulting company, Infozyme Consulting International, in 2001.
Safety surveillance has much to offer as a powerful knowledge-based tool capable of defending company products in the marketplace while conducting its primary function of safeguarding public health. However, this asset is not translating much beyond the cloistered walls of its practitioners in industry and health authorities.
Clearly, a formidable arsenal has been developed over time: a scientific conceptual base, legislation, data systems, sophisticated technological support - hard- and software - monitoring and analytical systems, quality controls with audit and inspection, and communication tools. The eyeforpharma conference on Drug Safety for Marketed Drugs, held in Amsterdam on 22-23 November 2005, demonstrated that, as a whole, this arsenal works. And yet there is a lack of awareness of its impact where it matters - the end user (the medical practitioner and patient).
This Conference Insights review comprises the highlights of a selection of presentations from the eyeforpharma conference, providing a platform for how and where the industry can improve drug safety. Crucially, it also outlines how companies can communicate the true and undoubted value of safety surveillance.
CONFERENCE PROGRAMME
Chairperson Day 1: Bernard Hart, Director of Clinical Science, AstraZeneca
Safety profiling: the pitfalls and solutions of real-world data John Parkinson, Director, GPRD
Understanding drug safety data and systems to ensure compliance with EU regulations, directives and guidelines Dr Elliot Brown, Principal Consultant and Managing Director, Elliot Brown Consulting
Discover how your pharmacovigilance systems must be organised in order to meet and anticipate regulatory requirements Dr Jenny Müller, Head of Affairs, Clinical Research Drug
Safety, German Pharmaceutical Industry Association (BPI) European databases: where are we? where have we been? where are we going? Dieter Konrad, Manager of Department of Information Processing, Boehringer Ingelheim
Clinical drug safety: integrate your safety risk management strategy from clinical drug development into your pharmacovigilance plans Craig Hartford, Head of Safety and Risk Management, Sandwich Site, Pfizer
Discover the limitations and opportunities of using technology solutions to gather & communicate safety data Simon Sparkes, Aris Global
Learn how to optimise data in registries as an essential risk management tool Nawab Qizilbash, Director, Oxon Clinical Epidemiology Services and Consultant Geriatrician (formerly, Director of Epidemiology and Evidence-Based Medicine, GSK)
Hear the latest developments from the ICH Points to Consider Working Group for Data Retrieval of MedDRA Coded Data Reinhard Fescharek, Chairman of the PtC Expert Working Group and Director Medical Global Drug Safety, Bayer Healthcare
Chairperson Day 2: Martin Fagan, CEO and Founding Partner, Infozyme Consulting International
Learn why EDC is a necessary device for improving safety reporting and how to implement a successful EDC reporting system Johann Pröve, Global Head of Data Acquisition and Management, Bayer Healthcare
From safety to pharmacovigilance Dr Herve Laurent, Senior VP SRS Europe, Quintiles
Overcome internal communication challenges: powerful methods for the implementation of fast and effective safety reporting processes Dr Elliot Brown, Principal Consultant and Managing Director, Elliot Brown Consulting
The future of drug safety management Nawab Qizilbash, Director, Oxon Clinical Epidemiology Services and Consultant Geriatrician (formerly, Director of Epidemiology and Evidence-Based Medicine, GSK)
Risk management plans: an effective process for their preparation and implementation Phil Weatherill, Head of Pharmacovigilance, Ipsen
Risks and opportunities of phase IV risk management programs Yola Moride, Associate Professor, Faculty of Pharmacy, University of Montreal
PANEL SESSION: Discuss techniques for enhancing your drug safety knowledge management
Moderator: Barry Hardy, InnovationWell Community of Practice Manager, Douglas Connect
Speakers: Sidney Kahn, MD, President, Pharmacovigilance & Risk Management, Inc. Peter Elkin, MD, Professor of Medicine, Mayo Clinic Jim Averback, President, Life Science Integration Partners Saad Shakir, Professor of Medicine and Director, Drug Safety Research Unit (DSRU), UK A Leander Fontaine, MD, President, Pharmaceutics
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