This 3-hour interactive course will enable you to:

• Gain an in-depth understanding of risk management programmes to enable you to define goals and objectives for optimal risk planning
• Learn from successful business models for risk management programmes and how to avoid industry pitfalls
• Make the business case for executing registry initiatives for different products to meet a broad range of objectives
• Determine how to use patient registries for costeffective and efficient risk management plans
• Examine the opportunities and challenges of using patient registries with take-home case studies

Course Leader: Director, Oxon Clinical Epidemiology Services and Consultant Geriatrician (Formerly, Director of Epidemiology and Evidence-Based Medicine, GSK)

Chairpersons Opening Remarks

Director of Clinical Science, AstraZeneca

How to streamline processes and ensure your safety reporting exceeds the requirements of global regulatory authorities every time

• Learn why the electronic communication for expedited reporting of ADRs is essential from the regulator’s point of view
• How to evaluate the effectiveness of electronic transmission of ADRs
• Identify the requirements for a high quality electronic transmission of ADRs for fast and effective data analysis
• Learn step-by-step methods for the implementation and recommendation of electronic reporting of ADRs for seamless safety reporting
• Proven techniques for analysing the advantages and problems of electronic transmission of ADRs

Head of Pharmacovigilance Unit, Paul-Ehrlich Institute

Understand drug safety data and systems to ensure compliance with EU regulations, directives and guidelines

• Harness future developments in the changing regulatory environment
• Identify safety system requirements and use this to implement and execute efficient pharmacovigilance plans
• Expert tips for understanding the investigation of safety data by inspectors and ways to anticipate or avoid risks
• Powerful methods for enhancing the quality aspects of your safety data to ensure compliance

Principal consultant and Managing Director, Elliot Brown Consulting

Discover how your pharmacovigilance systems must be organised in order to meet and anticipate regulatory
requirements

• Gain an understanding of the pharmacovigilance system in Germany as a model for regulatory requirements
• Evaluate differences between German and European requirements as an example of national divergences
• Up-to-date analysis of risk-management systems within the pharmaceutical industry e.g. “Rote Hand Brief” in Germany,
  comparable to “Dear Doctor Letters”

Head of Affairs Clinical Research Drug Safety, German Pharmaceutical Industry Association (BPI)

CASE STUDY: Clinical drug safety: Integrate your safety risk management strategy from clinical drug development into your pharmacovigilance plans

• Effective techniques for identifying your requirements for pre-approval clinical safety and risk management activities
• Easy-to-develop methods for gathering relevant safety data towards pharmacovigilance planning through drug safety review teams, cumulative safety reviews and safety signals
• Hear how early risk management strategies evolve into regulatory risk management
• Innovative plans for facilitating drug marketing authorisation applications using information collected from drug development risk management plans

Head of Safety and Risk Management Sandwich Site, Pfizer

Hear the latest developments from the ICH Points to Consider Working Group for Data Retrieval of MedDRA Coded Data

• Discover the impact of legacy data conversion on MedDRA coded data
• Hear about organisation specific data is addressed by MedDRA MSSO
• Find out the most up-to-date information on the use of grouping terms, the impact of granularity, multi-axiality on output results and general principles for data retrieval

Chairman of the PtC Expert Working Group and Director Global Drug Safety, Bayer Healthcare

Learn how to optimise data in registries as an essential risk management tool

• The basics: Learn about types of registries, their role in your risk management plan and how to ensure they are set up correctly
• Discover the most important factors in designing and utilising registries which allow you to take full advantage of their potential
• Ways to track ROI and continuing improvements from registry initiatives
• Best-practice guidelines for implementing risk management plans that guarantee efficient safety standards

Director, Oxon Clinical Epidemiology Services and Consultant Geriatrician (Formerly, Director of Epidemiology and Evidence-Based Medicine, GSK)

Quintiles Workshop

November 22nd, 4.45pm-6.45pm

Pharmacovigilance after market authorization, a new world: Definitions, processes and thoughts

Chair: Dr. Herve Laurent, Senior VP SRS Europe, Quintiles

Co-Chair: Professor Saad Shakir MB ChB LRCP&S FRCP FFPM FISPE MRCGP, Director, Drug Safety Research Unit, Southampton, UK


During this workshop you will learn:

• The difference between safety and Pharmacovigilance
• The difference in Pharmacovigilance before and after market  authorization.
• Post-marketing Pharmacovigilance is a real concern: how do we move  from small patient numbers to “real life” patients and reporting.
• The difference in processes between pre- and post-marketing Pharmacovigilance
• The difference between adverse events and adverse effects, including case studies
• How we can control Pharmacovigilance reporting of naieve investigators
• How we can track Pharmacovigilance reporting in the post-marketing era
• How can a CRO help small and large Pharma in post-marketing Pharmacovigilance
  

Networking Cocktail Party

6.45pm - 8pm

Chairpersons Opening Remarks:

Head of Special Projects, AstraZeneca

From Safety to Pharmacovigilance

During this presentation, the focus will be on:
The history of pharmacovigilance
The difference in Pharmacovigilance before and after market authorization.
Proactive pharmacovigilance planning

Dr. Hervé Laurent, Senior VP SRS Europe, Quintiles

CASE STUDY: Learn why EDC is a necessary device for improving safety reporting and how to implement a successful EDC reporting system

• Gain an in-depth understanding of EDC adverse event reporting from a comparison with paperbased reporting
• Determine who can access certain data-sets for the safety data review – and understand the implications of multiple access
• Understand the implications of external safety data in EDC trials and how to manage this data effectively
• Key essentials for reconciling final Serious Adverse Events (SAE) between your clinical and drug safety database for integrated data analysis

Global Head of Data Acquisition and Management, Bayer Healthcare

European Databases: Where are we? Where have we been? Where are we going?

• Understand EudaVigilance and how it links to ICH requirements
• Learn how the EudraCT database can be used for effective data management
• Hear how to take advantage of European databases and how your company can optimise their usage

Manager of Department Information Processing, Boehringer Ingelheim

Safety Profiling: the pitfalls and solutions of real-world data

• Effective methods for understanding safety data in trial real-world populations
• Efficacy to Effectiveness – Understand the risk benefit balance
• Learn how to identify and overcome observational pitfalls such as channelling and confounding
• Hear detailed information of real-world randomised database tracking studies for effective drug safety data analysis

Client Services Director, MEMO

Is the EU ready for the electronic reporting of Adverse Drug Reactions?

• Discover what the current requirements are for the electronic reporting of ADRs and the challenges that need be addressed
• Learn from Boots Healthcare’s experiences of implementing successful electronic reporting systems
• Understand how to overcome obstacles arising from regulatory authorities not being fully prepared for electronic submission of safety reporting

Head of Pharmacovigilance, Boots Healthcare

PANEL SESSION: Discuss techniques for enhancing your drug safety knowledge management

• Discover how a Community of Practice
  Approach to drug safety delivers efficient
  knowledge management results
• Expert tips on terminologies to internalise and
  communicate drug safety knowledge
• The “Drug Safety Knowledge Audit” - Proven
  techniques for evaluating how well your
  organisation responds to and understands drug
  safety data
• “Opening the Box on Drug Safety Technology” -
  Emerging technologies building the Drug Safety
  Body of Knowledge
• Cost-effective approaches to pharmacovigilance
  and risk management planning

Moderator: InnovationWell Community of Practice Manager, Douglas Connect
PLUS 4 senior pharmaceutical representatives from Europe and the USA!

CASE STUDY: Risk Management Plans: An effective process for their preparation and implementation

• Gain an in-depth understanding of risk management plans for marketed drugs
• Practical steps for evaluating the objectives and goals of risk management plans in order to assess when they are necessary
• Essential questions when implementing a process for risk management planning development and execution

Head of Pharmacovigilance, Ipsen

Risks and opportunities of Phase IV risk management programs

• Hear expert suggestions for overcoming methodological challenges of Phase IV risk management programmes
• Identify how your risk management plans can be utilised for a new promotion tool
• Are target populations for Phase IV risk management programmes the same as the population of users?
• Risk management programmes: the route for long-term product market viability

Associate Professor, Faculty of Pharmacy University of Montreal

CASE STUDY: Overcome internal communication challenges: Powerful methods for the implementation of fast and effective safety reporting processes

• Learn how to structure your internal communications for efficient processing of safety reports
• Find out how to analyse safety signals for compliance with labelling requirements
• Identify the correct method for evaluating the safety reporting of your drugs for changes in promotional representations

Affiliate Head of Pharmacovigilance and Regulatory Medical Affairs, Sanofi-Aventis

The future of drug safety management

• Discuss how drug safety management requires quality up front for long-term gains
• The latest inter-connected tools evaluated indepth: Intelligent databases speaking to Clinical & Regulatory Databases
• Transparency is a must: Understand your new customers, the patients and how to meet their demands for complete openness of drug safety information
• Communication strategy: the new era of the emerging Cinderella or how to drive your business for the best benefit-risk ratio

Director of Clinical Safety, PharmaMar