Dammika Peiris, Senior Pharmacovigilance Manager and Head of Chugai Pharma Europe

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1 Key Speakers: Paul Dolin, Head of Pharmacoepidemiology, Takeda Pharmaceuticals Dr. Katrin Freund, Project Excellence Manager (Social Media) Drug Safety & Epidemiology, Novartis Pharma GmbH Dr. Heike Schoepper, Head Global Drug Safety Regions, Merck Serono Karina Corware, Associate Safety Risk Lead(ASRL), Safety Surveillance & Risk Management, Pfizer Jean Kilgour-Christie,, Director, Deputy EU QPPV Global Pharmacovigilance, Takeda Dr. György Zörényi, Safety Medical Director, Oncology, AstraZeneca Dr. Ruxandra Rogosca, Global Pharmacovigilance Manager, Omega Pharma Michael Richardson, VP International GPV & E and EU QPPV, BMS Veronica Fjellström, Deputy QPPV, Bluefish Pharmaceuticals Bawan A. Ahmed, Senior Pharmaceutical Assessor, Kurdistan Regional Government-Iraq Dammika Peiris, Senior Pharmacovigilance Manager and Head of Chugai Pharma Europe Pharmacovigilance Office, Chugai Pharma UK Ltd Amer Alghabban, Vice President GxP Quality Assurance, Compliance and Training, Karyopharm Jackie Roberts, Director - Regulatory, PHV and Medical, Actavis Robert L Bencher, Director, Myriad-RBM, Inc. John Parkinson, Consultant Expert, Healthcare Data (Former Director CPRD, MHRA) Bob Peeters, IPM Private Sector Senior Manager, WCO Professor Saad Shakir, Director, Drug Safety Research Unit Sally Shorthose, Partner, UK, Bird & Bird Dr. Oleksandr Karpenko, Managing Director, Olexacon Pipasha Biswas - Director & QPPV, Symogen Limited Dr Ennis LEE Senior Partner, TranScrip Suzanna Gamwell, Client Advocate, Creation Healthcare

2 This year's forum is the place to gain the latest information Current regulatory trends in Inspections of the Signal Detection, Post-Authorisation Safety Studies(Pass) And Internal Audit. Use of social media in Pharmacovigilance. Incorporating Data Mining Technology in Spontaneous Reporting System. Strategic Pharmacovigilance pre and post product life cycle. Contemporary Regulatory scenario across Europe. Outsourcing Pharmacovigilance. Premium Sponsor Exhibitors Media Partners

3 14th June :40 09:20 Networking Coffee and Registration Chairperson's opening remarks: Paul Dolin, Head of Pharmacoepidemiology, Takeda Pharmaceuticals 09:30 Pharmacovigilance and Drug Safety- Global market overview Dr. Oleksandr Karpenko, Managing Director, Olexacon 10:00 Outsourcing Pharmacovigilance Jean Kilgour-Christie, Director, Deputy EU QPPV Global Pharmacovigilance, Takeda 10:30 11:00 Networking Coffee Connection between pharmaceutics and adverse reactions to medications Bawan A. Ahmed, Senior Pharmaceutical Assessor, Kurdistan Regional Government-Iraq 11:30 Implementing changes in pharmacovigilance regulations Dr Ennis LEE Senior Partner, TranScrip 12:00 Post approval signal management Karina Corware, Senior Manager, Associate Safety Risk Lead in Safety Surveillance and Risk Management in World Wide Safety Strategy, Pfizer 12:30 13:50 Networking Lunch Pharmacovigilance compliance: Considerations of a local affiliate through mergers and acquisitions Jackie Roberts, Director Regulatory, PHV and Medical, Actavis

4 14:20 The Utilisation of Biomarkers to Assess Drug Induced Liability What testing strategies are being implemented to ensure safe and effective therapies? How are biological tools helping reduce attrition rates? When will the government bodies require additional testing methods to be implemented? Who will pay for these tests and how will they be deployed in clinical practice? Robert L Bencher, Director, Myriad-RBM, Inc. 14:50 Current regulatory trends in inspections of Signal Detection, Post-Authorisation Safety Studies (PASS) and internal PV audit: Best practice in Signal Detection mind the gap 3rd anniversary of Module VIII (PASS) - impact on companies Efficient and effective internal PV audits be prepared Dr. Heike Schoepper, Head Global Drug Safety Regions, Merck Serono 15:20 15:50 Networking Tea Effective Patient Safety through Drug Safety Dr. Ruxandra Rogosca, Global Pharmacovigilance Manager, Omega Pharma 16:20 Panel Discussion: Pharmacovigilance- Future vision, goals and challenges Moderator- Michael Richardson, VP International GPV&E and EU QPPV, BMS Dr. Heike Schoepper, Head Global Drug Safety Regions, Merck Serono Dammika Peiris, Senior Pharmacovigilance Manager and Head of Chugai Pharma Europe Pharmacovigilance Office, Chugai Pharma UK Ltd 17:10 17:20 18:20 Chairperson's closing remarks Networking Drinks End of Day One

5 15th June :40 Networking Coffee and Registration 09:00 Chairperson's opening remarks Suzanna Gamwell, Client Advocate, Creation Healthcare 09:10 Challenges In Pre-Marketing Pharmacovigilance between the Science and Regulations Risk Management Plans ICSR causality assessment SUSAR reporting DSUR preparation Amer Alghabban, Vice President GxP Quality Assurance, Compliance and Training, Karyopharm 09:40 Challenges in Signal Management Activities Pipasha Biswas - Director & QPPV, Symogen Limited 10:10 Safety Data Exchange Agreement (SDEA) Veronica Fjellström, Deputy QPPV, Bluefish Pharmaceuticals 10:40 Networking Coffee 11:10 A Researcher's perspective of Risk Management Planning Fulfilling the need for innovation. Understanding the local health services in practice. Study design considerations. Real-life case examples. Prof Saad Shakir, Director, Drug Safety Research Unit 11:40 Effective and proactive risk minimization in early and late phase Oncology studies: a benefit for the whole life cycle of the product? Is effective risk minimization feasible in clinical trials? What tools do we have for effective risk minimization in clinical development? Can we measure the effectiveness of risk minimization in clinical trials? Does effective risk minimization have any benefit for the submission process/ labeling and post marketing risk management? Dr. György Zörényi, Safety Medical Director, Oncology, AstraZeneca 12:10 The WCO: anti-counterfeiting program and the use of technologies The IPM platform: a gateway of information and actionable resources IPR trainings and interception operations with customs Interoperability of track&trace and authentication technologies for customs agents Bob Peeters, IPM Private Sector Senior Manager, WCO 12:40 Networking Lunch

6 14:00 Social Media: Chances and Challenges for Pharmacovigilance Social media networks/platforms: New fields for the pharmaceutical industry How to manage AE reporting of information from the digital world Using Social Media for collecting AE information Dr. Katrin Freund, Project Excellence Manager (Social Media) Drug Safety & Epidemiology, Novartis Pharma GmbH 14:30 2nd Care Pharmacovigilance- Drugs and Devices Secondary Care- need for Pharmacoepi/vigilance Access to secondary care data Cardiovascular drugs and devices John Parkinson, Consultant Expert, Healthcare Data (Former Director CPRD, MHRA) 15:00 Contemporary Regulatory scenario across Europe Sally Shorthose, Partner UK, Bird & Bird 15:30 Chairperson's closing remarks 15:40 Networking Tea & End of Conference HOW TO REGISTER Online: Please use the discount voucher code to avail extra 50 off online registration. Call: +44 (0) Early Bird Registration Standard Registration (1st March 1st May 2016) Vat (From 2nd May 2016) Vat For group discounts and bookings, please info@recunnect.com For full terms and conditions, please visit