Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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12 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Pre-Conference Tutorials, Monday, March 8, 2010, 09:00 - 12:30 This medium/high level tutorial is aimed at those who wish to increase their PSUR preparation skills and to be prepared for the challenges the new regulations will bring. TUTORIAL 5 OPERATION OF EUROPEAN REGISTRATION PROCEDURES: CENTRALISED, MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES Truus Janse-de Hoog, Staff Member MEB, European Cluster, Chair CMD(h), Medicines Evaluation Board, The Netherlands European Medicines Agency instructor invited Presented by representatives from a national authority and the European Medicines Agency, this tutorial will provide a pragmatic view on how EU registration procedures work. The basic principles of the centralised, mutual recognition and decentralised procedures will be explained. Hints and tips will be given on how to avoid delays in the procedures and how to prepare for submission of applications that can involve 30 Member States. Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Understand the basic principles of centralised, decentralised and mutual recognition procedures • Recognise the difficulties that can be experienced during the operation of these procedures and apply practical solutions • Describe the main differences in the procedures and decision-making processes Target Audience Regulatory affairs, pharmaceutical industry personnel and students TUTORIAL 6 INTERACTIONS BETWEEN THE REGULATORY REGIME AND THE LEGAL PRINCIPLES GOVERNING INTELLECTUAL PROPERTY, COMPETITION AND PRODUCT LIABILITY FOR NON-LAWYERS Geneviève Michaux, Of Counsel, Covington & Burling, Belgium Interactions between, on the one hand, the regulatory regime and, on the other hand, intellectual property, competition and product liability rules are increasing. As a result, those matters can no longer be approached in isolation, and a more comprehensive perspective is required when addressing regulatory issues. This tutorial will explain key concepts of the laws governing intellectual property, competition, and product liability and discuss how they relate to the regulatory pharmaceutical regime. This tutorial is designed for non-lawyers with considerable regulatory experience and for regulatory lawyers who want to learn the basics of intellectual property, competition and product liability rules as they apply in the pharmaceutical sector. Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Explain and discuss the basics of intellectual property competition and product liability rules applicable to medicinal products • Identify and better address the regulatory issues that present an intellectual property, competition or product liability aspect Target Audience All persons involved in regulatory affairs and in-house regulatory lawyers TUTORIAL 7 QUALIFIED PERSON FOR PHARMACOVIGILANCE (QPPV): WHAT DO YOU NEED TO KNOW? Keith Wibley, Director Pharmacovigilance, NDA Regulatory Science Ltd., UK Janet Hormbrey, Executive Director, EU Qualified Person for Risk Management & Pharmacovigilance, Merck Sharpe & Dohme, Belgium EU legislation and the detailed guidance in Volume 9A require all marketing authorisation holders to have a qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of a marketing authorisation holder’s (MAH’s) pharmacovigilance system in the EU, as well as this system’s interfaces with other regions of the world. Although acknowledged to be a vital function, there is little practical guidance on how QPPV responsibilities should best be discharged, while maintaining compliance with regulatory requirements. The responsibilities of the QPPV apply wherever there is an active MA for a product authorised in the EU/EEA. Thus the role in many companies has a global impact. During this tutorial we will discuss and advise on current practice to help address issues such as: • What does being qualified mean in practice for the QPPV and their organisation? • What are appropriate contractual obligations and job description to cover points such as 24-hour availability, workload, personal indemnity, delegation and adequate back up? • How QPPV activities should be documented to ensure adequate quality assurance • How inspectors and regulatory authorities regard the QPPV role and their expectations for the level of the QPPV’s involvement in the global PV system • How recent changes to Volume 9A impact the QPPV role • How to make the QPPV role work in practice using examples from both large and small companies and external contract QPPVs • When a QPPV changes, what to do and how to notify authorities • How to optimise interactions between the company as a whole and the QPPV to obtain adequate mutual oversight and support • What should be the QPPV’s input into post-authorisation commitments, postauthorisation studies, PIPs and risk management plans? • How should the interface between the QPPV and different functions such as regulatory affairs, clinical development, product quality, QA and marketing work in practice? • How to ensure the appropriate authority and influence for a QPPV in different types of organisation • How the QPPV function relates to national nominated individuals for safety The speakers will also update the audience about whether there should be an appropriate forum to allow QPPVs across the industry to interact and share best practices to the mutual benefit of public health and industry alike. Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Explain legal, regulatory and business implications surrounding the QPPV function in order to permit the effective implementation of this role • Describe the expectations different stakeholders have of a QPPV • Understand the different approaches taken by various companies and the influence company size and product portfolio can have on this • Gain better insight into the evolving requirements of regulators and inspectors Target Audience Professionals in companies who are involved in running or setting up pharmacovigilance operations in the EU/EEA, or with responsibilities for postmarketing clinical safety and who are involved in: pharmacovigilance; clinical research; risk management; medical product safety assessment; data analysis; epidemiology; labelling; quality assurance and compliance; QPPVs; Deputy QPPVs; and contract research organisations and consultants
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Pre-Conference Tutorials, Monday, March 8, 2010, 09:00 - 12:30 TUTORIAL 8 ADAPTIVE DESIGNS FOR CONFIRMATORY CLINICAL TRIALS Norbert Benda, Statistical Methodologist, Novartis Pharma AG, Switzerland This tutorial will give an introduction to the theory and practice of adaptive designs for pivotal clinical trials. Adaptive designs allow for mid-course design modifications such as the adjustment of sample size, the dropping of treatment arms or the selection of a subpopulation. We will review and discuss statistical methodology that allows such adaptations without compromising the overall type I error rate. All methods will be illustrated by examples. Several case studies will be presented, explaining in detail both methodological and practical issues which arise in designing and analysing an adaptive clinical trial. Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Understanding the principles, opportunities and challenges for adaptive designs • Understand operational considerations Target Audience Clinical project team members within drug development TUTORIAL 9 IMPLEMENTATION OF THE EU VARIATION REGULATION: WHY – WHEN – WHAT Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, Denmark Peter Bachmann, Senior Expert, European Drug Regulatory Affairs and German Member of the CMD(h), BfArM, Germany The EU variation regulation came into force 1 January, 2009 and is mandatory to use from 1 January, 2010. What is the first impression on whether the implementation will provide a simpler, clearer and more flexible regulation for variations within Quality – Safety and Efficacy? Learning Objectives At the conclusion of this tutorial, attendees will be able to obtain an overview of: • Key issues from the EU variation regulation and implementation guidelines • How is the EU variation regulation compared to the US system? • Whether the implementation will give a simpler, clearer and more flexible regulation for variations within Quality – Safety and Efficacy? • Changes to biologicals compared to chemical entities – any differences? • What is a regulatory pre-approved protocol? Target Audience People involved in lifecycle management regulatory issues of late-stage development drug products and lifecycle management of approved products within quality/production, safety, clinical and regulation. TUTORIAL 10 ORPHAN DRUGS IN THE EU: FROM DESIGNATION TO MARKETING AUTHORISATION Katrin Rupalla, Associate Director, Regulatory Affairs Europe, Celgene International SARL, Switzerland Jordi Llinares, Head of Orphan Medicines, European Medicines Agency, EU In this tutorial you will hear about the orphan drug legal framework in general and what are the latest updates. In addition, this tutorial is meant to provide an overview of the orphan drug application process from designation to approval of marketing authorisation and its practical implications based on recent examples. This also includes in-depth review and analyses of topics such as orphan market exclusivity, similarity and significant benefit. Speakers will include experts from the European authorities, but you will also hear from industry representatives about the strategic aspects, experiences and learnings with regard to regulatory framework for orphan drugs in the EU. Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Apply the information they have obtained on procedures and requirements for an orphan drug application in the EU and US • Identify and respond to potential issues that may arise during an orphan designation procedure Target Audience This tutorial will be of interest to all those who would like to hear about the latest update of the orphan drug legal framework in the EU and most recent experience with regard to practical implications. They will be, in general, professionals from drug regulatory affairs, clinical science and public affairs. TUTORIAL 11 SIGNAL DETECTION METHODS FOR BEGINNERS – OVERVIEW AND CASE STUDIES Steve Jolley, Principal, SJ Pharma Consulting, USA Jacinta Aniagolu, Director, Pharmacovigilance & Risk Management, Synowledge, LLC, USA This tutorial will provide a theoretical and methodological review of the application of signal detection and data mining techniques to safety surveillance. An overview of strategies and specific situation applications will be presented. Highlights: • Recommended approach to signal detection and use of data mining techniques • Use of visualisation tools to enhance signal detection • Comparison of approaches for a large and small company Specific topics covered will include: • Analysis of demographics, risk assessment, dose effects, product interactions, and differences from known background rates • Strategies for incorporating all relevant data sources, including clinical trials, individual case reports, PSURs, external databases (FDA, WHO), and registries • Understanding the benefit/risk ratio of a product and how to discover product adverse event relationships • Measuring the strength of the relationship of the adverse event and the drug using the Bayesian Confidence Propagation Neural Network algorithm (BCPNN) • Illustration of the power of technology that can not only provide overall analysis, but also “drill down” to specific patient records Learning Objectives At the conclusion of this tutorial, attendees will be able to: • Recognise the basic concepts of data mining and principles of signal detection • Outline how to apply these techniques within their company • Discuss data mining techniques to analyse large volumes of adverse event report data Target Audience Clinical safety professionals involved in pharmacovigilance; pharmacoepidemiology; regulatory affairs; quality assurance; medical product safety assessment; labelling 13
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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