The pharmaceutical congress on Reporting Adverse Events, held in London 24-25 April 2006, and organised by SMi, brought together speakers and delegates from a wide range of pharmaceutical companies and Contract Research Organisations (CROs). Many of these speakers have direct responsibilities for safety and pharmacovigilance within their companies. This conference update proved an excellent and timely review of how companies are now dealing with new US and EU drug safety legislation, and the changing commercial demands, in the face of a progressively more difficult regulatory, public and political environment.
How companies now try to assess the risk-benefit of their drugs, and the development of risk management systems, were topics that recurred throughout the conference. It was clear that the search for industry best practices was still ongoing. Achieving adequate adverse-event signal detection emerged as a major public health issue, especially in the light of recent expensive, high-profile drug withdrawals, and one that can have massive leverage on company profitability. There was therefore an underlying theme that drug safety groups within companies should enjoy a much higher profile and a more prominent role in the strategic aspects of risk-benefit optimisation of products.
Advances in technology and data harmonisation were also recurring themes. The conference highlighted recent improvements in the use and availability of safety data for both physicians and consumers, which will mean that avoidable adverse drug reactions can be greatly reduced by providing the right drug safety information to doctors and patients, in the right context, at the right time.
CONTENTS
Reporting Adverse Events - Programme
Introduction
About the author
Background
Current legislative environment - EU
Current legislative environment - USA
Safety risk management and clinical development
Prominent drug safety issues change FDA and industry practices
Global aspects of adverse event reporting
Role of Eudravigilance in drug development
RxWise: effective ADR avoidance by complete medication safety checking
The future of pharmacovigilance in Europe
Conclusions
References
ABOUT THE AUTHOR
Formerly senior lecturer in paediatric cardiology at Great Ormond Street Hospital in London, Dr Richard Wyse now has joint commercial and academic careers. He is the author of over 100 medical and scientific papers, and pharmaceutical industry articles in journals. He has also written four industry books, and several independent evidence-based medicine reports in various therapeutic areas. Commercially, he has worked for a CRO as Director of European Health Economics, and as Medical Director for a US pharmaceutical IT company, and a medical device company. He has been involved in a wide variety of industry clinical trials and several other areas of drug development for many years. Academically, he is currently a visiting professor in Saudi Arabia and President-Elect of the Division of Genetics at the Royal Society of Medicine. He is on the editorial board of several journals.
Richard has spoken at many academic and international pharmaceutical and medical device conferences, and has chaired 25 of them. Notably, he was global chairman of a major cardiac patient database initiative that involved 2700 hospitals worldwide, speaking at national conferences in a large number of first- and third-world countries. In this capacity he reported a landmark paper on risk prediction and outcomes in more than 600,000 US patients.
These are challenging times for drug safety professionals. Much is to be done within the profession to gain and maintain public trust by improving drug safety, pharmacovigilance and risk management practices. In the USA, drug-related adverse reactions (ADRs) result in an estimated 100,000 deaths per year, and up to 5% of all hospitalisations involve some of the most widely prescribed drugs. Less than 10% of ADRs are currently reported back to the manufacturer or the regulatory authorities.
Mandatory legislation changes have altered the landscape on both sides of the Atlantic. Product safety is a key element, and the clinical trial process is now more highly regulated. These changes cover applications to ethics committees, clinical trial study monitoring, adverse event reporting during trials, clinical practice audits and inspections, and preparing for marketing authorisation of products. The European Union (EU) Clinical Trials Directive has had a great impact on post-marketing surveillance. It introduced two new terms to the pharmacovigilance vocabulary: SUSAR (a suspected unexpected serious adverse reaction) and SAR (a serious adverse reaction). The pharmacovigilance requirements of the Food and Drug Administration are also evolving, especially in the areas of electronic submissions, pre-marketing safety assessment plans and risk management.
The SMi Reporting Adverse Events conference discussed various tactical and transactional aspects of safety, providing an overview of strategic aspects of risk assessment and risk management. This Conference Insights review provides analysis of the most salient issues raised in selected presentations at the event. These included electronic reporting, signal detection, high-profile drug withdrawals, drug risk-benefit assessments, the implementation of risk management and a glimpse into future developments.
Industry professionals are currently being forced to react to changing regulatory requirements, internal company integration and public/political pressures. This report highlights how the industry is addressing these evolving needs. It concludes that drug safety groups should play a more prominent role not only in the procedures mentioned above but also in strategic aspects of risk-benefi t optimisation.
CONFERENCE PROGRAMME
Day one Chairperson: Dr Sean Zhao, Director, Global Safety, Pharmacoviligance, Amgen, USA
IMPACT OF THE CLINICAL TRIALS DIRECTIVE: Post May 2004 Dr Dipti Amin, Senior Vice President, Clinical & Scientific Operations, Medical Affairs, Quintiles
CHANGES IN REGULATORY THINKING AND ACTIONS: Lessons from the front lines Dr Kenneth Hintze, Director, Global Safety & Pharmacoviligance, Kendle
ROLE OF EUDRAVIGILANCE IN DRUG DEVELOPMENT Gurdyal Kalsi, Director, Medical Affairs, MDS Pharma Services
THE FDA’S ADVERSE REPORTING SYSTEM: An adequate surveillance system for approved drugs? Dr Sven Knudsen, Life Sciences Statistical Consultant, Insightful Ltd
A COMPREHENSIVE NEW MEDICATION SAFETY CHECKING TOOL THAT UNIQUELY EMPOWERS CONSUMERS, PHYSICIANS AND PHARMACISTS ACROSS THE ENTIRE PRESCRIPTION, OTC & HERBAL SPECTRUM Dr Richard Wyse, Chairman, Economic Healthcare Associates, UK
REPORTING ADVERSE EXPERIENCES FOR COMBINATION PRODUCTS: Work in progress Mason W Diamond, DDS, Vice President, Clinical & Regulatory Affairs, Tyrx Pharma
AGGREGATE ADVERSE EVENT REPORTING AND DRUG SAFETY RISK MANAGEMENT TOOLS Jennifer Markey, Vice President, Practice Management, Intrasphere Technologies John Whitebrook, Vice President, Pharmaceuticals, Intrasphere Technologies
COLLECTION, MANAGEMENT, DISTRIBUTION AND ANALYSIS OF SUSPECTED ADVERSE DRUG REACTION INFORMATION: What are the reporting requirements for adverse drug reactions for all products reported in the EU? Simon Sparkes, Vice President, Global Sales & Marketing, ArisGlobal
GLOBAL ADVERSE EVENT REPORTING: How reporting and regulatory requirements vary country to country Dr Livia Stankovics, Affiliate Pharmacovigilance Head, Sanofi -Aventis
Day two Chairperson: Dr John Ferguson, Vice President, Pharmacovigilance, Millennium Pharmaceuticals
SAFETY DATA REPORTING IN ELECTRONIC SUBMISSIONS Guy Pawson, Manager, Electronic Submissions, Genentech
SIGNAL DETECTION: The most important objective of pharmacovigilance Dr Tjeerd-Pieter Van Staa, Head, Research, General Practice Research Database, Medicines & Healthcare Products Regulatory Agency (MHRA)
GLOBAL PRODUCTS SAFETY: Shielding products from risk Dr Sean Zhao, Director, Global Safety, Pharmacovigilance, Amgen, USA
SAFETY RISK MANAGEMENT AND CLINICAL DEVELOPMENT: A product life cycle perspective Dr Joanna Haas, Vice President, Pharmacovigilance, Genzyme
RISK MANAGEMENT PRINCIPLES TO PHARMACOVIGILANCE: Securing the safety of products Dr John Ferguson, Vice President, Pharmacovigilance, Millennium Pharmaceuticals
PV QUALITY ASSURANCE: Case study - PV QA tools and techniques implemented by large pharmaceuticals Brian Dinardo, Partner, Drug Safety Group, LLC
TOOLS TO HELP MINIMISE RISK IN PHARMACOVIGILANCE: Developing a risk conscious environment Professor Ragnar Lofstedt, Director, King’s Centre for Risk Management
FUTURE OF PHARMACOVIGILANCE IN EUROPE: What will happen next? Dr Birgitt Gellert, Drug Safety Manager, Bayer Vital
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