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Your Tailored Pharmacovigilance Agenda

Suggested agenda for attendees interested in Pharmacovigilance

Wednesday 26 March

Panel Discussion: Making the Pharmacovigilance Legislation Work – A Temperature Check
9:00-10:00 AM 
This session will explore the expriences of implementation of the new pharmacovigilance legislation from the point of view of multiple stakeholders. The new legislation has had impact across a broad range of safety related activities, however this session will focus on areas where we have seen fundamental changes. The session will be conducted as a panel discussion where views from a PRAC member, a Member State Competent Authority, the industry and a patient perspective will be heard. The panel will consider if the objectives of the new legislation are yet being met, in particular with respect to the need to consider risks in the context of benefit, the increased focus on management of risk in the post-marketing environment and the role of Pharmacovigilance Risk Assessment Committee (PRAC). The panel will also discuss their views on the impact of the transparency measures on communication and decision-making.

Thinking Beyond Old Pharmacovigilance Boundaries
11:00 AM-12:30 PM
Explore opportunities where pharmacovigilance scientists might bring their expertise into the drug development design space. Incorporating the voice of the patient into safety study design and identifying benefit/risk attributes early in development will be discussed.

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Surviving Safety and Quality Inspections in the Era of Globalisation: Harmonising Systems and Processes Across Company Units

11:00 AM-12:30 PM
Receive details of at case studies from large Pharma on implementing processes for monitoring and ensuring compliance with safety submissions globally.

Regulatory Town Hall Meeting
2:00 PM-3:30 PM

Put burning questions to expert regulators about transparency, implementation of pharmacovigilance legislation, latest changes to clinical trial legislation, innovation – products in the pipeline and EU-enlargement with Croatia.

Current Industry Practice For Benefit/Risk Governance
4:00-5:30 PM
A case study will be used to illustrate changes made to a company’s existing safety risk governance model to include expanded functional stakeholders necessary to align on a comprehensive benefit/risk characterisation. The session will also review the ongoing debate regarding the qualitative vs. quantitative methods used for benefit/risk evaluations and the importance of standardised process.

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Regulatory Intelligence in Practice – How Regulatory Authorities Inform About Decision Making
4:00-5:30 PM
This session will take a look at some of the hidden treasures found on regulatory agency websites , discuss potential changes regarding provisions of information, and address how stakeholders can get the most out of what is available. Attendees will also consider differences between agencies and regions (EMA, National Agency, HMA initiatives, US, Canada) and use a case study to illustrate different approaches, e.g. with regard to the types of information published on outcome of assessment work.

Thursday 27 March Transparency in the Pharmaceutical Sector – What Have We Learned?
9:00-10:30 AM
This panel discussion will address recent developments in the transparency domain, such as the increased visibility of the ‘all trials campaign’ and the release of Periodic Safety Upgrade Reports (PSURs). Has increased transparency led to greater levels of public trust in the pharma regulators and does it help patients make informed choices regarding taking specific medicines?

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The Changing Face of the EMA – Inside and Out: An Overview of the New Structure and Expectations from the Changes

9:00-10:30 AM
In 2013, the EMA embarked on a journey to re-shape the organisation and prepare for the future. The agency’s internal structure has been re- designed to better support the European medicines network and work of the agency's scientific committees, to better share data held by the agency, and to better meet the needs of the agency’s stakeholders. This session will provide an update on the transition to the new structure and practical insight into some of the changes that are underway to its operating processes, including the reinforced product team concept and what it will mean for applicant companies.

Moving From Risk Management to Benefit/Risk Management Planning
11:00 AM-12:30 PM
Find out about regulatory guidance and recommendations and how this changes planning of the risk management strategy and the study portfolio from industry, regulatory and research centre perspectives.

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How to Realise Biosimilars’ Full Potential
11:00 AM-12:30 PM
If not adequately addressed pharmacovigilance, naming and traceability can limit the potential of biosimilars before it is fully realised. This session will review these three independent but interlinked challenges, providing case studies to reflect on what needs to be done to ensure the conversation remains focused on patient safety first.

Periodic Benefit Risk Evaluation Reporting – Has it Achieved What it Set Out to Do?
2:00-3:30 PM
The Periodic Benefit Risk Evaluation Report’s main objective is to present a comprehensive, concise, and critical analysis of new or emerging information on the risks of the medicinal product, and on its benefit in approved indications, to enable an appraisal of the product’s overall benefit-risk profile. This session will evaluate whether this aim is being met, with regulatory and industry perspectives and a panel discussion.

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BIG DATA, Ehealth Records And Taxonomy
2:00-2:30 PM
Find out about the goal of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on benefit/risk.

Risk Minimisation and its Effectiveness – What is State of the Art and What is Realistic?
4:00-5:30 PM
Receive an overview of different perspectives regarding advances in pharmaceutical risk minimisation – regulatory, academia, and CIOMS IX. 

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Risk Perception, Risk Acceptance and Known Active Substances
4:00-5:30 PM
Our decisions, although based on the same safety information on medicines, show diversity that implies. Our risk perception and risk acceptability differs across the EU depending on interested groups, cultural background and tradition. We will discuss the risk perception and risk acceptability from the points of view of a National Competent Authority (NCA), a patient, and industry and try to find common points of understanding of risk acceptance, and consequences in practice linked mostly to medicines with known active substances.