RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT SEPTEMBER 2017 I VIENNA

Transcription

1 4TH ANNUAL RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT SEPTEMBER 2017 I VIENNA Pharmacovigilance Industry Market GROWTH, TRENDS AND ANALYSIS Safety Evaluation Regulatory Affairs Patient Support Programs PV Inspection and Audit Readiness Silver Sponsors Organized by

2 SPEAKERS PANEL INCLUDE Luke Keitel Head of Global Quality & Compliance APCER Life Sciences Magnus Nord VP Global Patient Safety CVMD AstraZeneca Martin Henzl Director Baxter Heike Schoepper MD, PhD, MBA Head of GDS-PV Management, Research & Development, Global Medical Affairs and Global Drug Safety Biopharma Jean Marie Heim MD Toxicologist, Group Medical Director, Global Pharmacovigilance and Epidemiology Bristol Myers Squibb Katalin Timár-Horváth Managing Director ComFit Europe Kft. Dr.Reinhard Fesharek Head of Global Clinical Safety & Pharmacovigilance CSL Behring Jan Cleerbout Director, Medical Safety Officer Johnson & Johnson Sandra Meyer Pharmacovigilance Alliance Head Novartis Karsten Lollike Corporate Vice President NovoNordisk Pilar Carrero Vice President, QPPV Office Novo Nordisk Kristof Vanfraechem Global Head International Pharmacovigilance Felix Arellano Global Head of Pharmacovigilance and Drug Safety Lydie Marcelon Deputy Director Pharmacoepidemiology and Risk Management Sanofi Pasteur Melanie Essavez-Roulet Country Quality Oversight Lead, Global Pharmacovogilance Sanofi Katharina Hartmann Head Pharmacovigilance Vaccines Takeda Pharmaceutical Company Limited Monika Manske Associate Director, Global Pharmacovigilance Governance, Head Pharmacovigilance Quality System Mylan PRE-CONFERENCE WORKSHOPS 12 September 2017 (15:00-16:00) The future trends 12 September 2017 (16:00-17:00) Risk Minimization Measures (RMM) New technologies and innovative methods in pharmacovigilance are emerging, but do you know how to utilize them? Dive deeper into safety and risk management issues and solutions in the EU through real-world experiences Enlightened evolution of regulatory science that speeds needed products to prescribers and patients Future strategies for growth in Pharma Engagement of patients in the future product development and regulatory processes Utilize new approaches to present benefit-risk data and communication of risk-benefit messages to health care providers, patients and consumers Individual consideration of each safety concern which is described in the safety specification needs Determining the most suitable risk minimization measure When are you successful with your RMM? How to measure evaluate effectiveness of RMM? What are the contributing factors Seriousness and severity of the potential AEs Its preventability or the clinical actions required to mitigate the risk

3 DAY 1 Wednesday 13 September :20 Registration and Morning Coffee 08:50 Opening Remarks from the Chairperson 09:00 SPEED NETWORKING SESSION Don t forget your business cards! GREAT 15 MINUTES ICE-BREAKING AND NETWORKING ACTIVITY to meet your peers before we start. 09:15 CASE STUDY Innovative approach to clinical development Current developments in the field of dengue prevention and control Methods to improve dengue situation in the region Katharina Hartmann Head Pharmacovigilance Vaccines Takeda Pharmaceutical Company Limited 10:00 CASE STUDY Case study - New Vaccine Launch: How to improve PV awareness and reporting in low middle income countries? The introduction of a new Dengue vaccine was targeting the first launched in low and middle income countries through mass vaccination campaigns. The LMIC countries have heterogeneous PV systems and some require capacity building. In this context, the ultimate objective is to avoid to jeopardize the mass vaccination campaign after launch due to a lack of information regarding the safety of the vaccine / minimize the risk of media crisis and false signal. Stimulation of AEs reporting by patients/hcp is critical to further characterize the safety profile of our new vaccine in real life setting. Implement an easy-to-use web and interactive solution to collect the PV data from HCP through PC, tablets and smartphones. Set-up a prospective multi-national non-interventional post-authorization safety study consisted of a Cohort Event Monitoring using standardized data collection instruments through patient cards to be distributed to vaccines & electronic Case Report Form to be filled in by HCPs. Melanie Essavez-Roulet Country Quality Oversight Lead, Global Pharmacovogilance Sanofi Lydie Marcelon Deputy Director Pharmacoepidemiology and Risk Management Sanofi 10:45 NETWORKING COFFEE BREAK 11:15 CASE STUDY What is automation in pharmacovigilance? Pharmaceutical companies are continually tasked with gathering more safety information and responding to evolving and often changing - requiremenets more quickly. PV organisations must decide whether their current systems for handling safety information across rely too much on manual methods. This presentation is intended as a discussion into the possibilities and challenges of automation in PV Modern work platforms are emerging on the market Transition to automation: is that simple? What is the organisational impact of this transformation Pilar Carrero Vice President, QPPV Office Novo Nordisk 12:00 CASE STUDY Finding the optimal benefit-risk balance What is the expected and actual (individual) benefit for a specific patient? What is the weight of evidence that supports that a risk exists? How serious is the risk and does the risk outweigh the benefit? How often is it that the risk will occur and is it preventable? Will it decrease/disappear after a drug is stopped or will the risk increase over time? Are there any other treatment options where the benefit-risk balance is more favorable or less favorable? Heike Schoepper, MD, PhD, MBA Head of GDS-PV Management Research & Development Global Medical Affairs and Global Drug Safety Biopharma 12:45 LUNCH 14:00 CASE STUDY Best practices in the field of PSMF New regulations in emerging markets Reviewing EU requirements Highlighting the importance of the master file in communication Revising techniques Monika Manske Associate Director, Global Pharmacovigilance Governance, Head Pharmacovigilance Quality System Mylan 14:45 PRESENTATION Quality Assurance Auditing in Pharmacovigilance Pharmacovigilance has become a complex global web of regulations, systems, and partnerships. This presentation will review the current factors driving the need to be inspection-ready and the role of quality assurance auditing in demonstrating a compliant organization to regulators around the world. Luke Keitel Head of Global Quality & Compliance APCER Life Sciences

4 DAY 1 Wednesday 13 September :30 PRESENTATION Presentation by: Make the most out of your Summit networking and create meaningful business connections! Katalin Timár-Horváth Managing Director ComFit Europe Kft. Features of Summit App 16:15 NETWORKING COFFE BREAK 16:45 CASE STUDY Taking PV Outsourcing to the Next Level through Partnership Growing demands on Pharmacovigilance as well as finite resources have prompted organizations to accelerate efficiency initiatives, including the outsourcing of operational tasks and support activities. Following a value stream assessment, we took the next step: Partnership with a vendor providing the computerized system in a Software as a Service model, all case processing and most other operational support. This presentation summarizes our experience in setting up this partnership and managing it for the first 18 months. Transformation of Pharmacovigilance at Baxter Streamlining interfaces with vendors through partnership Managing vendor service levels Deploying PV applications in Software as a Service models Martin Henzl Director Baxter 17:30 DISCUSSION Interactive Panel Discussion In this session, the audience has an opportunity to ask questions and have an open interactive discussion with the discussion panellists. Implementing a readiness program for the Eudravigilance Upgrade Benefits and challenges of the new system Developing a communication plan to ensure all necessary information is circulated Magnus Nord AstraZeneca Martin Henzl Baxter Lydie Marcelon Sanofi Pasteur Monika Manske Mylan See Minute by Minute Programme Connect online with other Delegates and Speakers before, during and after the Summit ARE YOU A SOLUTION PROVIDER? Allan Lloyds provides a range of options for the relevant industry Solution Providers to participate in our events. We provide you with an unrivalled opportunity to develop meaningful relationships with decision makers and create a competitive advantage to gain maximum return on investment. Showcase your products or technologies with our sponsorship possibilities accessible by all summit delegates. TO BOOK YOUR STAND Contact please Mr. Sam Khalaf on or bus.dev@allanlloyds.com Add most interesting Sessions to your Calendar 18:15 RECEPTION Cocktail reception All attendees will have a great opportunity to discuss with their peers.

5 DAY 2 Thursday 14 September :20 Registration and Morning Coffee 08:50 Opening Remarks from the Chairperson 09:15 CASE STUDY Signal detection and strategies Overview of requirements and methods, current issues and stakeholders Jan Cleerbout Director, Medical Safety Officer Johnson & Johnson 10:00 CASE STUDY The country staff as a strategic opportunity in patient centric risk management Kristof Vanfraechem Global Head International Pharmacovigilance 10:45 NETWORKING COFFEE BREAK 11:15 CASE STUDY Learnings from PV Inspections (Europe and Arabic League) Feedback from PV inspections are part of shaping the PV systems. The presenter will discuss findings from EMA PV Inspection, especially focus on IT-systems. The presenter will also highlight major findings from global PV inspections especially in Arabic countries where new PV legislation is enforced. PV Inspections EMA Arabic League IT-Systems Literature Monitoring OC of in-coming cases Karsten Lollike Corporate Vice President NovoNordisk 12:00 CASE STUDY Delivering Strategic Clinical Drug Safety and PhV - Learnings from AstraZeneca The last few years AstraZeneca-MedImmune has developed the clinical drug safety and pharmacovigilance organisation to shift focus from routine license-to-operate and pharmacovigilance activities, to strategic support for decision-making for drug projects and products. This has included advancing predictive and reactive scientific approaches in drug safety, launching a new operating model and organisational structure and reducing the procedural framework over 60%, key learnings and case studies from this journey will be presented. Refocus from Routine License-to-operate activities to Strategic support for decision-making Novel Predictive Statistical methods and Mechanistic PK-PD modeling for safety Using Large Data Networks for Clinical Drug Safety and PhV-Risk Management Reducing the Procedural framework in a major global pharmaceutical company Off-shoring vs Outsourcing of routine safety tasks Magnus Nord VP Global Patient Safety CVMD AstraZeneca 12:45 LUNCH 14:00 CASE STUDY Innovation in PV SM as a platform for pharma companies to create awareness Further opportunities to identify drug safety issues directly with patients What can be achieved with the above Felix Arellano Global Head of Pharmacovigilance and Drug Safety 14:45 CASE STUDY Global regulatory landscape for PV how has it evolved and where is it headed? Europe - EMA requiring name of qualified person (QPPV); PV system master file (PSMF) and serious adverse events to be submitted within 15 calendar days Will product safety become more standardized globally and how? Sandra Meyer Pharmacovigilance Alliance Head Novartis 15:30 CASE STUDY Benefit risk assessments during life cycle of a product This presentation will guide you through how to establish general company-wide oversight and consistency in benefit risk assessments during life cycle of a product starting from early stage development until post- approval space. Different situations where structured benefit : risk framework can help and support good decision making, from go / no-go decisions, stage gate decisions, risk management decisions etc. What elements do we ideally include in benefit: risk discussions / decisions, what data do we need to generate and how we integrate different perspectives (individual patients, populations, health authorities, payers, company, etc.) Dr. Reinhard Fesharek Head of Global Clinical Safety & Pharmacovigilance CSL Behring

6 DAY 2 Thursday 14 September :15 CASE STUDY Successful risk-benefit assessment Jean Marie Heim MD Toxicologist, Group Medical Director, Global Pharmacovigilance and Epidemiology Bristol Myers Squibb 17:00 NETWORKING COFFEE BREAK 17:30 DISCUSSION Interactive Roundtable Discussion All attendees will have a great opportunity to discuss a selection of the most interesting topics addressed during the conference in small groups with their peers. Every table will nominate a head of table, which will summarize the topic discussed, present the main puzzles, and questions posed. PV perspectives Justifying the use of additional risk minimization tools when routine measures cannot ensure the favourable benefit-risk ratio of a medicine The process of planning and implementing additional risk minimisation tools or programs these measures should facilitate and strengthen the cooperation between the patient and the physician as much as possible Use of process and outcome indicators Applying of additional measures that may be used simultaneously making up a complex program Allan Lloyds is the leading provider of the most diversified business intelligence events. Quality has always been our priority and we understand every industry is unique with different needs and challenges. We turn events into a unique experience based on interaction, discussions and networking. Today, we are trusted by senior experts within Fortune 500 companies as a top business enriching interaction event provider. Our summits bring in a diverse group of speakers and initiate sessions on topics going beyond any usual case studies. These summits can change the course of your business and lead to a sustainable relation between your company and customers. All Attendees Discuss with your peers and share knowledge 18:15 CLOSING REMARKS FROM THE CHAIRPERSON Things to do in Vienna: No visit to Vienna is complete without a visit of this magnificent palace Schoenbrunn Palace. The gardens are a must. Did you know Vienna also has a Walk of Fame? Instead of containing celebrities like in LA, this walk of fame is full of composers who had some sort of connection with Vienna. Visit massive cathedral is the true centerpiece of Vienna - St. Stephen s Cathedral VENUE VIENNA I am looking forward to welcoming you personally at the Risk Management and Pharmacovigilance Summit in September! Sidonia Jamborova Production Manager

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